Power morcellation

.
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