Power morcellation
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. Heute wird nicht mehr diskutiert, ob die Laparoskopie eine Rolle in der gynäko-onkologischen Chirurgie haben kann oder soll. Die Anwendungsbereiche der minimal-invasiven Chirurgie sind heutzutage gut definiert. Zusammenfassend kann man sagen, dass die gesamte Chirurgie der pelvinen Tumoren mit normalen Anatomie laparoskopisch gut durchgeführt werden kann (PortioCa St.1a-b; EndometriumCa St.1 ; stadiative pelvine und paraortocavale Lymphadenektomie; BOT; nicht epitheliale Ovarialtumoren; OvarialCa St. Ia): Vorauszusetzung ist allerdings die adequate Kompetenz des einzelnen Chirurgen. Eventuell kann noch diskutiert werden, ob die klassische Laparoskopie, oder die roboterunterstützte minimal-invasive Chirurgie zu bevorzugen sind. Im Gegensatzt dazu ist die laparotomische Option immer noch für die Tumoren mit lokaler oder topographischer Veränderung der Anatomie (Ovar-Tube-PeritoneumCa im fortgeschrittenem Stadium; übergrosse Ovaralrumoren) und für die uterine Leiomyosarkome notwendig. The use of laparoscopic staging and/or surgery in the field of gynaecological oncology was pioneered in the late 80's and the first reports were published in the early 90's. The issue has been initially most controversial and is still debated, with some justification, considering the possible adverse consequences of surgical mismanagement of gynaecologic malignancy. Since then, a number of papers have confirmed the absence of significant adverse effects on survival after laparoscopic diagnosis or surgery in gynaecological cancers. New developments cover virtually all the basic techniques in cancer surgery. New indications, such as pelvic sentinel node identification, decisional laparoscopy in adnexal malignancies, or the use of pretherapeutic surgical staging of uterine cancers, have been developed in direct relation with the use of laparoscopic techniques. Worldwide interest clearly demonstrates that laparoscopic techniques must now be part of the armamentarium of the gynaecologic oncologist. Postoperative morbidity and recurrence risk do not seem to be affected. Cost-efficiency of laparoscopic procedures is based on the reduction of hospital stay and recovery time, particularly in obese patients. Combined training in gynaecologic oncology and in laparoscopic is more than ever mandatory to avoid the risk of inadequate staging or management of pelvic malignancies. Bull Cancer. 2007 Dec;94(12):1063-71. [Laparoscopic surgery and gynaecological cancers]. Querleu D1, Leblanc E, Ferron G, Narducci F, Rafii A, Martel P. Daher, werden hier nur einzelne spezifische Bereiche der pelvinen minimalinvasiven Onko-Chirurgie behandelt: Risiken der uterinen Manipulation in der minimal-invasiven Chirurgie des EndometriumCa Sentinel node im EndometriumCa Typ 1 und im PortioCa ab St II Die Problematik des Morcellements in den Leiomyofibromen des Uterus “Fagotti score” bei Karzinomen von Ovar-Tube-Peritoneum Die Rolle der Laparoskopie in den rezidivierenden pelvinen Tumoren Risiken der uterinen Manipulation in der minimal-invasiven Chirurgie des Endometriumkarzinoms Uteriner Manipulator • Mobilisiert den Uterus (optimaler Inzidenzwinkel für die Instrumente) • Spannt die anatomischen Strukturen im Operationsbereich • Erhöht die Distanz zwischen Uterus, Harnblase, Ureteren, Darm und vermindert somit das Risiko von Verletzungen • Vereinfacht die Identifizierung der Plica vesicouterina, des Douglas und der Vaginalwand unterhalb der Zervix • Einige Modelle tragen zur Erhaltung des Pneumoperitoneums während der Kolpotomie bei • Kann die transvaginale Extration des Uterus nach der Kolpotomie erleichtern Cohen uterinemanipultor WisapMedicalTechnology uterinemanipultor Storz uterinemanipultors Tintara uterinemanipultor(Storz) ClermontFerrand uterinemanipultor(Storz) ClearViewEthicon uterinemanipultor RUMI/Koh-Ef&icientSystem (Coopersurgical) uterinemanipultor Endometrialcancer FredericAmant,PhilippeMoerman,PatrickNeven,DirkTimmerman, ErikVanLimbergen,IgnaceVergote DepartmentofObstetricsandGynaecology,DivisionofGynaecologicalOncology,UZGasthuisberg,Katholieke Universiteit,Leuven,Belgium. TheLancet08/2005;366(9484):491-505 Poor prognostic histopathological factors for 5-year overall survival in women with endometrial cancer Surgical stage High tumour grade and non-endometrioid-type lesions Depth of myometrial invasion or distance between serosaand tumour Involvement of lower segment Vascular-space involvement Aneuploidy Endometrialcancer FredericAmant,PhilippeMoerman,PatrickNeven,DirkTimmerman, ErikVanLimbergen,IgnaceVergote DepartmentofObstetricsandGynaecology,DivisionofGynaecologicalOncology,UZGasthuisberg,Katholieke Universiteit,Leuven,Belgium. TheLancet08/2005;366(9484):491-505 Omissis ...In the absence of randomised trials on this issue, we believe that laparoscopy is a valuable alternative to laparotomy in a selected group of patients. Manipulation of tumour,including macroscopically involved lymph nodes, shouldbe avoided to prevent the rare occurrence of portsitemetastasis. Furthermore, the use of an intrauterine manipulator should be avoided, since it results in a high frequency of positive peritoneal cytology and might contribute to vaginal-cuff recurrence.147-149 ...omissis 147 Sonoda Y, Zerbe M, Smith A, et al. High incidence of positiveperitoneal cytology in low risk endometrial cancer treated bylaparoscopically assisted vaginal hysterectomy. Gynecol Oncol 2001;80:378–82. 148 Vergote I, De Smet I, Amant F. High incidence of positiveperitoneal cytology in low risk endometrial cancer treated bylaparoscopically assisted vaginal hysterectomy. Gynecol Oncol 2002;84:537–39 149 Schneider A. Vaginal cuff recurrence of endometrial cancer treatedby laparoscopic assisted vaginal hysterectomy. Gynecol Oncol 2004;94:861–63. Servizio Sanitario Regionale Emilia-Romagna 2006 IL PERCORSO DIAGNOSTICO-TERAPEUTICO DELLE PAZIENTI AFFETTE DA TUMORE DELL’ENDOMETRIO. LINEA GUIDA INTERAZIENDALE RUOLO DELL’ENDOSCOPIA NEL TRATTAMENTO DEL CARCINOMA DELL’ENDOMETRIO Da una ricerca medline al 2006 son individuabili circa 100 studi di cui solo 3 prospettici randomizzati per un totale di 308 casi. Non sono presenti attualmente metanalisi. E’ in corso un trial prospettico randomizzato di fase III condotto dal GOG su 2.500 pazienti. L’analisi attuale risente perciò della limitatezza degli studi e della loro eterogeneità. Sono stati riportati casi di metastasi “port-site”, di recidive sulla cupola vaginale, di maggior numero di citologie peritoneali positive post-intervento. Sono indicate alcune attenzioni tecniche per ridurre i possibili rischi quali il non utilizzo di manipolatore uterino, la diatermocoagulazione delle tube all’inizio della procedura, la sutura delle sedi di introduzione dei trocar. Trattandosi in gran parte di segnalazioni isolate non è attualmente calcolabile la reale incidenza di queste possibili complicanze. Int J Gynecol Cancer. 2008 Sep-Oct;18(5):1145-9. doi: 10.1111/j.1525-1438.2007.01165.x. Epub 2008 Jan 22. Does the use of a uterine manipulator with an intrauterine balloon in total laparoscopic hysterectomy facilitate tumor cell spillage into the peritoneal cavity in patients with endometrial cancer? Lim S1, Kim HS, Lee KB, Yoo CW, Park SY, Seo SS. The objective of this study was to determine if total laparoscopic hysterectomy using a uterine manipulator with an intrauterine balloon increases the risk of positive peritoneal washings in patients with endometrial cancer. Three sets of peritoneal washings were obtained during surgery from 46 women with endometrial cancer at the Center for Uterine Cancer, National Cancer Center, Korea, between May 2004 and July 2006: the first before the insertion of the uterine manipulator (premanipulator), the second after clipping the fallopian tubes and inserting the uterine manipulator (postmanipulator), and the third after the removal of the uterus through the vagina (posthysterectomy). The cytology samples were examined by the same cytopathologist for the presence of malignant cells. Two of 46 (4.3%) patients were upstaged to IIIA disease due to positive cytology conversion after the insertion of the uterine manipulator, one after the insertion of the uterine manipulator, and the other after the hysterectomy. However, during the follow-up for 3-28 months (median 18), neither of the 2 patients experienced a tumor recurrence. In conclusion, using a uterine manipulator with an intrauterine balloon during the laparoscopic surgery for endometrial cancer might be associated with positive cytologic conversion. Possible explanations are retrograde seeding of tumor cells into the peritoneal cavity, the pressure effect of the inflatable manipulator tip and spillage of preexited tumor cells More effective preventive methods such as distal tubal clipping or coagulation of the fimbriae may be necessary in treating women with endometrial cancer between the isthmus and the fimbriae. LA DONNA IL FASCINO DELLA GINECOLOGIA MODERNA TRA SALUTE E SICUREZZA DELLA DONNA : AGGIORNAMENTI E NECESSITÀ MONTECATINI TERME 12 - 13 - 14 APRILE 2012 ComunicazionI orali - oncologia ginecologica USO DEL MANIPOLATORE UTERINO E RISCHIO DI SPILLAGE PERITONEALE DI CELLULE NEOPLASTICHE IN CORSO DI ISTERECTOMIA TOTALMENTE LAPAROSCOPICA PER CANCRO DELL'ENDOMETRIO Daniela Lico,Roberta Venturella,Rita Mocciaro,Nicola LaFerrera, Francesco Gallo,Giovanni Prota, Michele Morelli, Fulvio Zullo Università Magna Grecia e di Catanzaro ~ Catanzaro Tumoral Displacement into Fallopian Tubes in Patients Undergoing Robotically Assisted Hysterectomy for Newly Diagnosed Endometrial Cancer DeLair, Deborah M.D.; Soslow, Robert A. M.D.; Gardner, Ginger J. M.D.; Barakat, Richard R. M.D.; Leitao, Mario M. Jr M.D. Robotic surgery is increasingly being performed for endometrial cancer. Robotic hysterectomies (RH), like traditional laparoscopic hysterectomies (LH), involve a significant amount of uterine manipulation. The use of a manipulator is thought to possibly increase the incidence of artifactual tumor displacement beyond the endometrium, including the fallopian tube. The objective of this study was to determine whether there is an association between RH and tumor present in the fallopian tube lumina. All RH and LH cases performed for endometrial cancer from May 2007 to August 2009 were reviewed. Of the cases not converted to laparotomy, 137 RH and 184 LH were identified. Age, body mass index, operative and hysterectomy time, type and grade of tumor, stage, pelvic wash results, and the presence of detached tumor fragments (contaminants) in the lumina of the fallopian tubes were recorded. Appropriate statistical tests were applied. Of the 184 LH, 4 (2.2%) were reported to have detached fragments of tumor in the lumina of the fallopian tubes compared with 16 of the 137 (11.7%) RH cases (P<0.001). The majority of the patients with RH and tumor present in the tubes had Stage I disease (9/16, 56.2%) and Grade 1 tumors (9/16, 56.2%). Four (4/16, 25%) patients had Stage IIIa disease detected by a pelvic wash. Patients with contaminants had a higher body mass index, but the difference was not statistically In conclusion, our data demonstrate an association between RH and tubal contamination. The clinical significance of this phenomenon remains to be determined. significant and was possibly due to small numbers. The role of uterine manipulators in endometrial cancer recurrence after laparoscopic or robotic procedures Christos Iavazzo , Ioannis D. Gkegkes Introduction The evolution of minimally invasive surgery has been established and both laparoscopic- and roboticassisted techniques can be presented as valuable alternatives to traditional approaches for the treatment of gynecological cancers, such as endometrial cancer. During laparoendoscopic procedures, the upward traction to the uterus is considered fundamental. The application of uterine manipulators in hysterectomy can facilitate diverse tasks to lead to a safe and successful surgical outcome. Some authors have raised their concern that the use of uterine manipulators might increase the incidence of tumor cell dissemination among patients with endometrial cancers. Methods We performed a literature search with terms related to the role of uterine manipulators in endometrial cancer recurrence in PubMed and Scopus. Results Six articles were identified dealing with this issue. Even though, the available clinical evidence suggests that the application of uterine manipulators has no clear correlation with the recurrence of the endometrial carcinoma, the existing trials are of low methodological quality. Conclusion Further investigation is necessary for the clarification of the influence of the different types of uterine manipulators in cancer recurrence. Studie Gyn Bz Inzidenz von L1 im histologischem Befund Vergleich zwischen laparotomischer und laparoskopischer LPT K Endometrio totaler Hysterektomie Infiltrazione Linfovascolare SI 2012-2015: 73 Fälle EndometriumCa St I Totale interessamento Linfovascolare Infiltrazione Linfovascolare TOT Infiltrazione Linfovascolare NO LPS + LPT LPS K Endometrio Assenza di Infiltrazione Linfovascolare Infiltrazione Linfovascolare SI Infiltrazione Linfovascolare NO Studie Gyn Bz über die Inzidenz von L1 im histologischem Befund in einem Vergleich zwischen laparotomischer und laparoskopischer totaler Hysterektomie Es konnte gezeigt werden, dass die Anwendung des Uterusmanipulators beim endometrioiden Endometriumkarzinomen FIGO I die Inzidenz der Mikrolymphgefäßinvasion durch neoplastische Zellen (L1) nicht erhöt; doch ist jedenfalls diese so hoch, dass man die Möglichkeit einer Mikrogefäßinvasion durch Mikrotraumata der Cavumwand nicht unterschätzen darf. Daher sollte die Anwendung von nicht/wenig traumatisierenden Uterusmanipulatoren bevorzügt werden. Die Verwendung von Balloonmodellen, welche keine Verletzungen der Uteruswand verursachen, erscheint daher adeguat. Zudem sollte eine präventive isthmische Tubenkoagulation durchgeführt werden Sentinel node beim Endometriumkarzinom Typ 1 und Zervixkarzinom ab St II Sentinel node 1960 GOULD führ das Konzept von Sentinel node ein (Paratiroyd) 1966 CHAIPPA entdeckt die Existenz von primären lymphatischen Zentren in den Hoden. Meherere Studien über die chirurgische Lokalisierung und die histopathologische Auswertung von metastatischen Lymphknoten folgen 1970 KETT verwendet Methylenblau als Kontrastmittel in Fällen von MammaCa und erkennt dass ein Abfluss Richtung axillärer Lymphgefässe und Lymphknoten existiert 1977 CABANAS führt die erste Beschreibung des Sentinel nodes, indem er von einem spezifischen lymphatischen Zentrum im Peniskarzinom berichtet 1992 MORTON berichtet, dass obwohl der primäre Weg der Metastatisierung bei malignen Melanomen der lymphatische Weg ist, ist die RoutineLymphadenektomie im St. I oft negativ. Sentinel node Sentinel node Wichtigkeit des lymphatischen Status bei gynäkologischen Tumoren Lymphknotenmetastasen haben eine negative prognostische Bedeutung und korrelieren mit einer Reduktion des OS der Patientinen. Die Evaluirung des Lymphknotenstatus kann durch Imaging oder chirurgisch erfolgen; letzeres ist allerdings sicherer. Durch Imaging kann es in 25% bei FIGO I e II und 65-90% bei FIGO IIIB zu einer Fehlbewertung kommen CT und MR können in 20-25% zur fehlerhaften Bewertung der paraortocavalen Lymphknoten führen. Die PET hat einen Erkennungsfehler von 22% in Lymphknotenmetastasen < 5 mm Sentinel node Es gibt ausreichend wissenschaftlich publizierte Evidenz bezüglich der SSNB (selektive Biopsie des Sentinelknotens) beim zervikouterinen Karzinom. Bis 2012 sind in Studien 800 registrierten Fällen publiziert (SENTICOL Studie) Mittels SSNB werden im Vergleich zur Standard-Lymphonodektomie ca. doppelt so viele Lymphknotenmetastasen diagnostisiert, vor allem durch die Möglichtkeit: - der Erkennung von aberranten Lymphabflusswegen - der Durchführung von histopathologischer Ultrastadierung und dadurch der Erkennung von Mikrometastasen Sentinel node Sentinel node Sentinel node Lokalisierung Imaging Gammakamera Visualisierung des Farbstoffes in LPS/LPT Sentinel node Intrazervikale Injektionstechnik: In das Zervikalstroma werden 4 ml injeziert, verteilt auf 4 Quadranten, bwz. bei 03 e 09 Uhr. Eventuell wiederholbar mit weiteren 2 ml im Falle unzureichender Färbung Sentinel node Sentinel node Sentinel node Die Technik mit Farbmittel (Methylenblau) allein hat eine Detektionsrate des SN von nur 50% Die Kombination Methylenblau und Radiotracer zeigt bessere Ergebnisse, ist aber schwieriger in der praktischen Durchführbarkeit Sentinel node Sentinel node Sentinel node IDOCYANIN-GRÜN ICG Gynecol Oncol. 2012 Jul;126(1):25-9. doi: 10.1016/j.ygyno.2012.04.009. Epub 2012 Apr 13. Detection of sentinel lymph nodes in patients with endometrial cancer undergoing robotic-assisted staging: a comparison of colorimetric and fluorescence imaging. Holloway RW, Bravo RA, Rakowski JA, James JA, Jeppson CN, Ingersoll SB, Ahmad S. OBJECTIVE: To retrospectively compare results from lymphatic mapping of pelvic sentinel lymph nodes (SLN) using fluorescence near-infrared (NIR) imaging of indocyanine green (ICG) and colorimetric imaging of isosulfan blue (ISB) dyes in women with endometrial cancer (EC) undergoing robotic-assisted lymphadenectomy (RAL). A secondary aim was to investigate the ability of SLN biopsies to increase the detection of metastatic disease. METHODS: Thirty-five patients underwent RAL with hysterectomy. One mL ISB was injected submucosally in four quadrants of the cervix, followed by 0.5 mL ICG [1.25mg/mL] immediately prior to placement of a uterine manipulator. Retroperitoneal spaces were dissected for colorimetric detection of lymphatic pathways. The da Vinci(®) camera was switched to fluorescence imaging and results recorded. SLN were removed for permanent analysis with ultra-sectioning, H&E, and IHC staining. Hysterectomy with RAL was completed. RESULTS: Twenty-seven (77%) and 34 (97%) of patients had bilateral pelvic or aortic SLN detected by colorimetric and fluorescence, respectively (p=0.03). Considering each hemi-pelvis separately, 15/70 (21.4%) had "weak" uptake of ISB in SLN confirmed positive with fluorescence imaging. Using both methods, bilateral detection was 100%. Ten (28.6%) patients had lymph node (LN) metastasis, and 9 of these had SLN metastasis (90% sensitivity, one false negative SLN biopsy). Seven of nine (78%) SLN metastases were ISB positive and 100% were ICG positive. Twenty-five had normal LN, all with negative SLN biopsies (100% specificity). Four (40%) with LN metastasis were detected only by IHC and ultra-sectioning of SLN Il ruolo del verde indocianina per la valutazione del linfonodo sentinella Morosato, Federico (2013) Il ruolo del verde indocianina per la valutazione del linfonodo sentinella. Università di Bologna, Corso di Studio in Ingegneria biomedica - Cesena Obiettivo: dimostrare l'equivalenza tra la sensibilità del Verde Indocianina e quella del Tecnezio radioattivo nella detezione del linfonodo sentinella(LS), nei pazienti affetti da carcinoma mammario allo stadio iniziale. Metodi: linfoscintigrafia con Tc99m-marcato, attraverso Gammacamera e con Verde Indocianina, attraverso Photo Dinamic Eye, per la detezione del LS. Utilizzo della sonda Gamma Probe per la discriminazione dei linfonodi radioattivi da quelli non radioattivi. Analisi statistica dei dati. Risultati: sono stati studiati 200 pazienti per un totale di 387 linfonodi asportati; la sensibilità del ICG risulta essere del 98,09%. Studi statistici hanno confermato la non significatività dei parametri di BMI, taglia mammaria, dose iniettata, tempo iniezione-incisione per il rintracciamento del numero corretto di linfonodi (al massimo 2). Conclusioni: l'elevata sensibilità del ICG permette di affermare l'equivalenza tra la capacità di detezione dei LS con le due sostanze(Tc e ICG). A livello operativo la tecnica con ICG facilita l'asportazione del LS. Data la non significatività della dose di ICG iniettata per la detezione del numero corretto di linfonodi, clinicamente conviene iniettare sempre la dose minima di farmaco. https://youtu.be/-pJvnq_PB24 Herausgegeben am 03. August 2014 SN mapping in early stage endometrial cancer with ICG using the Storz HD Camera with ICG technology. Operator: Alessandro Buda, MD. Assistants: Rodolfo Milani, Professor; Cuzzocrea Marco, MD; Signorelli Mauro, MD. Gynecology Department San Gerardo Hospital, University of Milano-Bicocca, Monza (Ita Sentinel node IDOCYANIN-GRÜN ICG Sentinel node Videoclip Op Gyn Bz Die Problematik der Morcellierung uteriner Leiomyofibrome Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication Recommendations for Health Care Providers: Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids. Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer. Carefully consider all the available treatment options for women with symptomatic uterine fibroids. Thoroughly discuss the benefits and risks of all treatments with patients. For individual patients for whom, after a careful benefit-risk evaluation, laparoscopic power morcellation is considered the best therapeutic option: Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis. Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis. Other Resources: American College of Obstetricians and Gynecologists (ACOG)’s Statement on Choosing the Route of Hysterectomy for Benign Disease November 2009 (Reaffirmed 2011) disclaimer icon Society of Gynecologic Oncology (SGO)’s position statement on morcellation published in December 2013 disclaimer icon American Association of Gynecologic Laparoscopists (AAGL)’s AAGL Member Update: Disseminated Leiomyosarcoma With Power Morcellation 2014 disclaimer icon OUPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication Date Issued: Nov. 24, 2014 Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer and the recommendation that doctors share this information directly with their patients, are part of FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels. Recommendations for Health Care Providers: Be aware of the following new contraindications recommended by the FDA; Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.) Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy. OUPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication Other Resources: FDA News Release: FDA warns against using laparoscopic power morcellators to treat uterine fibroids Recommended Labeling Statements for Laparoscopic Power Morcellators (PDF - 151KB) Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff FDA Obstetrics and Gynecology Panel Meeting Materials-July 10 and 11, 2014 Society of Gynecologic Oncology (SGO)’s position statement on morcellation published in December 2013 American Congress of Obstetricians and Gynecologists (ACOG)’s Statement on Choosing the Route of Hysterectomy for Benign Disease November 2009 (Reaffirmed 2011) American Association of Gynecologic Laparoscopists (AAGL)’s AAGL Member Update: Disseminated Leiomyosarcoma With Power Morcellation 2014 Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication Date Issued: April 17, 2014 If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids. Paul H. Sugarbaker, MD, FACS, FRCS writes: ... When I first heard of the “morcellation technology” for uterine fibromas, I was convinced, as a result of my clinical experience, that unsolvable problems were created as a result of this technology. I have personally taken care of patients who had morcellation of a uterine leiomyosarcoma (ULMS) that was disseminated within the abdomen and pelvis as a result of this technology. It is impossible for me to know how often this occurs but I can say from my experience that it is a reality and that is devastating. The first and foremost requirements of cancer surgery are perfect CLEARANCE and absolute CONTAINMENT of the malignant process. In those unusual patients who have ULMS within a uterine fibroid, these principles of cancer surgery are violated... Copyright © 2014 Liddy Shriver Sarcoma Initiative. Power morcellation Also: das Problem besteht; es sollte allerdins nicht überwertet werden. Im klinischen Alltag geht es im Grunde um zwei Problemfälle: - Endometriumkarzinome, die erst postoperativ durch die histologische Untersuchung erkannt werden. - Atypische uterine Leiomyome oder, viel seltener, uterine Leiomyosarkome die erst postoperativ durch die histologische Untersuchung erkannt werden Diese klinische Probleme werden, vor allem, durch die LSK-Hysterektomie (besonders LaSH) oder LSK-Myomektomie relevant, da sie im Falle von intraabdomineller Morcellierung zur Streuung von Tumorzellen führen könnten. Power morcellation Dem Problem kann im klinisch-praktischen Alltag auf drei Ebenen begegnet werden, die nicht unbedingt alternativ zueinander sind: A) Prävention durch adeguate Diagnostik, um in suspekten Fällen eine Laparoskopie mit Morcellierung zu vermeiden B) Vermeidung der Durchführung von Morcellierung C) Endobag-Morcellierung Power morcellation Die Prävention des Steuungsrisikos von Endometriumkarzinomszellen bei Morcellierung nach Hysterektomie, kann leicht erziehlt werden, indem präoperativ, routinemässig bei programmierten LaTH, LaSH o LAVH wegen Fibromyomatose oder AUB eine ambulante Endometriumbiopsie durchgeführt wird. Dieses Verfahren ist in über 90% der Fällen ambulant mit Anwendung von Einmalinstrumenten, eventuell mit Lokalanästhesie (Emla vaginal oder Mepivakain zervikal) durchführbar. Power morcellation Schwieriger ist die Prävention des Steuungsrisikos von Leiomyosarkomen oder atypischen Leiomyomen während Morcellierung nach LSKMyomektomie oder -Hysterektomie. Es gibt keine bildgebende Technik, die in der Lage ist, benigne Myome von atypischen Myomen oder gar von Leiomyosarkomen mit Sicherheit zu unterscheiden. Doch klinisch-praktisch kann man im Falle von schnell wachsenden Myomen, die im Echo-Doppler eine diffuse Neovaskularisierung nachweisen, eine MRT durchführen lassen; diese kann den V.a. ein Malignom weiter erhärten und die Operation sollte somit laparotomisch durchgeführt werden. Power morcellation Power morcellation Die Vermeidung der Morcellierung entfernt klarerweise in toto das Streuungsrisiko von nicht vorher erkannten Tumorzellen. Es sollten Operationstechniken entwickelt bzw. angewandt werden, die unter Erhalt der positiven Effekten der minimal-invasiven Chirurgie, das geringe Risiko der Streuung neoplastischer zellen zur Gänze ausschließt Das Uterusmyom ist der häufigste solide pelvine Tumor der Frau und betrifft 4 bis 25% der weiblichen Bevölkerung mit Frequenzspitze im Alter 35-50 JJ. Nur nur 10% sind symptomatisch. Das Risiko einer malignen Entartung eines Uterusmyom Richtung Leiomyosarkom ist gering (< 0,2%). In Italien würden 120000 Frauen eine minimal-invasive Chirurgie vorenthalten, um 240 Frauen mit Uterussarkomen adäquat ohne Morcellierung zu operieren. Power morcellation Power morcellation Vermeidung der Morcellierung Alternative Surgical Techniques In an effort to promote surgical techniques that would mitigate the risks of power morcellation, various options have been suggested as potential ways to prevent the dissemination of tissue while maintaining the claimed benefits of minimally invasive procedures. En-bloc resection techniques involve removing tissue completely intact in an attempt to avoid power morcellation and the risk of spreading tissue fragments. To accomplish this, methods such as minilaparotomy, a surgically enlarged ancillary port, or transvaginal extraction may be used. However, each of these procedures comes with its own set of possible complications, and it is unclear whether or not the risk of tissue dissemination is alleviated. Praktisch werden Uterus oder Myom en bloc durch Anwendung von Minilaparotomie (Myomektomie oder LaSH) oder transvaginal (LAVH) entfernt Power morcellation Power morcellation Endobag-Morcellierung Alternative Morcellation Techniques Some industry representatives argue that if power morcellators are left on the market, competition will drive companies to find new solutions that will strive to mitigate the risks. Some proposed methods include vaginal morcellation and transvaginal extraction, but most common were techniques involving various types of containment bags. “In bag morcellation” techniques have been suggested as a means of reducing the risk of tissue dissemination. However, after examining the permeability, integrity, and ability to execute various morcellation techniques within various surgical bags and other “containment strategies,” the FDA could not verify the efficacy of these methods to effectively reduce the morbid and cancer-spreading risks of power morcellation due to a lack of definitive data. Power morcellation Endobag-Morcellierung Alexis Contained Extraction System This new innovation enables minimally invasive procedures by creating a contained environment for manual morcellation. The Alexis contained extraction system features a large specimen containment bag and a guard to protect the bag from sharp instrumentation. Designed as a complete solution for contained manual morcellation, this device is available in several kit configurations to support multi-port, reduced port, and single incision techniques. Power morcellation Endobag-Morcellierung Enclosed morcellation using a large bag www.youtube.com/watch?v=xs9Wj6ou8CE Contained morcellation in a modified Endo Bag https://youtu.be/aLDZj0nRKFM In-Bag Morcellation with LIMAS Safety Isolation bag https://youtu.be/v1rjN1i9NNU “Fagotti score” im Ovar-Tuben-PeritonealKarzinom Primary surgery is the standard treatment for stages I-II The potential indications of neo-adjuvant chemotherapy are confined to stages III-IV Whether performed primary or as an interval debulking procedure, cytoreductive surgery must be complete (leaving no gross macroscopic residual disease), Suboptimal cytoreductive surgery must be avoided (Level 1 Grade A) Recommended pre-treatment assessment of resectability is: Clinical evaluation taking into account the general condition (ECOG score or Karnofsky index) and nutritional status (weight, albumin and pre-albumin tests) of the patient Anaesthesiology workup (ASA score) Laboratory test workup: CA 125, CA 19-9 if mucinous tumor (Expert opinion) Radiological workup: Chest-abdominal-pelvic CT scan MRI is not recommended as part of the standard workup PET scan is not recommended as part of the standard workup for stages III but is optional for some cases of stage IV disease (Expert opinion) Laparoscopy is the best way of assessing initial resectability Findings complete the information provided by imaging and laboratory tests; also provides the histological diagnosis (biopsy) indispensable for therapeutic decision-making (Level 2 Grade A) Use of a carcinomatosis extent evaluation score is recommended -Laparoscopic evaluation: Fagotti score -Median laparotomy with a view to complete cytoreduction: Sugarbaker's Peritoneal Cancer Index (PCI) (Level 2 Grade A) Neoadjuvant chemotherapy can be offered for stage III malignancy if: - There are medical and/or anaesthetic contraindications for primary surgery - Carcinomatosis extent does not allow a primary complete cytoreduction, this has to be assessed by a trained surgical team (Level 1 Grade A) Three courses must be given before surgery is proposed. (Level 2 Grade B). If interval debulking surgery is performed after more than 3 neoadjuvant chemotherapy courses, the procedure must be followed by at least 2 courses of adjuvant chemotherapy. (Expert opinion) Fagotti laparoscopic score (2008) - Omental cake - Peritoneal carcinomatosis - Diaphragmatic carcinomatosis - Mesenteric retraction - Stomach infiltration - Liver metastases Each parameter was attributed a score of 0 to 2. Cytoreduction is incomplete in 100% of patients with a score ≥ 8 Sugarbaker's Peritoneal Cancer Index (PCI from 0 to 39) OBJECTIVE: The aim of this study was to compare carcinomatosis scores, and to determine their relevance to predict resectability, morbidity, and outcome. STUDY DESIGN: From 2005-2008, 61 patients underwent surgery for ovarian cancer. We compared International Federation Gynecology and Obstetrics (FIGO), peritoneal cancer index, Eisenkop, Aletti, Fagotti, and Fagotti-modified scores. RESULTS: There was a strong correlation between the different scores. In predicting resectability, Fagotti-modified and peritoneal cancer index outperformed other scores. We demonstrated a strong association between the occurrence of postoperative complications and Aletti, peritoneal cancer index, and Eisenkop scores (P < .0001). For progression-free survival, we observed significant differences among FIGO, peritoneal cancer index, Eisenkop, Fagotti-modified, and Aletti stages (P < .05). For stage III/IV patients, only Aletti score remains significant to predict resectability. This suggests that complete respectability is more related to the surgical effort than to the extent of the disease. CONCLUSION: Alternative ranking systems provide additional information over FIGO for complete resectability, complications, and survival Am J Obstet Gynecol. 2010 Feb;202(2):178.e1-178.e10. doi: 10.1016/j.ajog.2009.10.856. Comparison of peritoneal carcinomatosis scoring methods in predicting resectability and prognosis in advanced ovarian cancer. Chéreau E1, Ballester M, Selle F, Cortez A, Daraï E, Rouzier R. Fagotti score Video-clip Op Gyn Bz Laparoskopie bei Rezidiven von pelvinen Tumoren Der theoretische Vorteil der chirugischen Behandlung von Rezidiven besteht in der Entfernung von den größeren Tumormassen mit geringeren Mitoseraten und verminderter Neovaskularisation: beide Faktoren verringern die Wirkung einer Chemotherapie. Dabei könnte die Chirurgie auch jene Tumorrezidive behandlen, die großteils aus Chemo-resistenten Zellen bestehen. Klinische Studien berichten über interessante OS-Ergebnisse: 37-66 Monate (kein Aszites; guter Performance-Status; minimal oder gar abwesender Resttumor) Die meisten positiven Ergebnisse sind in den Platin-sensiblen Rezidiven erziehlt worden. Die sekundäre Zytoreduktion sollte bei Progressionen unter Chemotherapie oder innerhalb 6 Monaten nach Chemotherapie (Platin-resistent) nicht durchgführt werden. Eine Metaanalyse von 40 Studien über die Jahre 1983-2007 von 2019 operierten Patientinnen mit Platin-sensitiven Rezidiven, hat die Faktoren untersucht, welche mit dem grössten OS-Zuwachs verbunden sind. Es hat sich ergeben, dass die einzige unabhängige Variable, die “optimale” sekundäre Zytoreduktion ist. Daher ergibt sich die Notwendigkeit, Kriterien zu identifizieren, welche ermöglichen, Patientinenn zu selektieren, bei denen eine “optimale” sekundäre Zytoreduktion mit grosser Wahrscheinlichkeit durchgeführt werden kann. Die Studie Desktop 1 aus dem Jahr 2006 (retrospektive Analyse über 267 Pat. von 26 deutschen Zentren) hat einen “prediction score” von möglicher Sekundärzytoreduktion (AGO* score) vorgeschlagen. Die 3 wichtigsten Parametern sind folgende: A) ECOG** performance status 0 B) Resttumor abwesend nach primärer Zytoreduktion C) Abwesenheit von Aszites Bei Vorliegen aller 3 Parameter, besteht die Möglichkeit, eine vollständige Resektion des Rezidivs zu erreichen Dieser AGO score ist weiterhin in der prospektiven Studie Desktop II validiert worden. * Arbeitsgemeinschaft Gynaekologische Onkologie ** Eastern Cooperative Oncology Group Boston US-MA Weiters können die Evidenzen, über die Anwendung der intraoperativen Chemohyperthermie (HIPEC) in Verbindung mit der Sekundärchirurgie der OvarialCa-Rezidiven genannt werden. Tale tecnica prevede la somministrazione del chemioterapico in soluzione riscaldata a 41° direttamente in cavità peritoneale per un tempo variabile all’incirca dai 30 ai 60 minuti al termine di un intervento chirurgico citoriduttivo definito come ottimale. Die Theorie auf welcher HIPEC basiert, ist das Erreichen hoher Konzentrationen des Chemotherapeutikums in direktem Kontakt mit der Peritonealoberfläche: somit könnten die therapeutischen Effekte verbessert und systemische Nebenwirkungen reduziert werden. L’ipertermia (ovvero la somministrazione di una soluzione chemioterapica precedentemente riscaldata) aumenterebbe inoltre la chemio-sensibilità cellulare esercitando un effetto diretto sulla permeabilità delle membrane. Nell’ambito del trattamento del carcinoma ovarico una recente review ha analizzato i risultati di tale strategia terapeutica ottenuti in19 studi retrospettivi condotti in 10 diverse Istituzioni di riferimento riportando una sopravvivenza globale mediana variabile dai 22 ai 64 mesi, Allerdings sind schwere Morbidität (12-63%), sowie Mortalität (0,9-10%) bei der mit HIPEC behandelten Patientinnen sehr hoch. . Tuttavia la natura retrospettiva di tali esperienze, l’eterogeneità delle popolazioni studiate (pazienti platino-refrattarie e platino-sensibili) e dei farmaci chemioterapici utilizzati (cisplatino, oxaliplatino, paclitaxel, oxorubicina peghilata ecc…) e la variabilità del timing in cui queste procedure sono state effettuate (chirurgia primaria, chirurgia di intervallo, second look, chirurgia secondaria rappresentano i limiti di tale analisi. Nel 2011 è stato invece pubblicato uno studio prospettico monoistituzionale effettuato su una casistica accuratamente selezionata di 41 pazienti con recidiva platino sensibile di carcinoma ovarico sottoposte a citoriduzione secondaria ottimale e successiva HIPEC con Oxaliplatino: i dati mostrano una mediana di intervallo libero da malattia e di sopravvivenza globale rispettivamente di 24 e 38 mesi con un tasso di complicanze del 34.8% e nessun decesso correlato al trattamento. Zusammenfassend, zeigen die in diesem Bereich durchgeführten Studien interessante und zuversichliche Daten, doch unterstreichen sie auch die Notwendigleit der strengen Selektion der Patientinnen und der Konzentration von Fällen nur in Refernzzentren, um die positiven Effekten zu optimieren und die negativen Nebenwirkungen zu reduzieren. Weitere Studien scheinen notwendig zu sein, bevor HIPAC eine klinischpraktisch anwendbare Therapie wird. Mit diesem Ziehl kann HIPEC laparoskopisch in der Form der PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) durchgeführt werden. Die laparoskopisch-chirurgische Behandlung von Rezidiven ist nicht nur durchführbar, sondern sogar häufig zu bevorzügen. Dies aus 2 Gründen: A) Überprüfung der Machbarkeit der Sekundärchhirurgie durch LSKInspektion B) Erleichterung der Sekundärchirurgie durch: – Sichtvergrösserung – Vereinfachung die tieferen Lagen zu erreichen Die HIPEC ist laparoskopisch in der Form der PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) durchführbar https://youtu.be/hXYrxT5omSw https://youtu.be/hXYrxT5omSw LSC nella recidivia pelvica Clip OP-Bilder Gyn Bz Behandlung eines Zentralrezidives nach AdenoCa des ZK, nach primärer Chirurgie in anderem Zentrum LSC nella recidivia pelvica Clip OP-Bilder Gyn Bz Behandlung eines Zentralrezidives von AdenoCa des ZK, nach primärer Chirurgie in anderem Zentrum LSC nella recidivia pelvica Clip OP-Bilder Gyn Bz Behandlung eines Zentralrezidives von AdenoCa des ZK, nach primärer Chirurgie in anderem Zentrum
