Trial Description Organizational Data

DRKS-ID: DRKS00007701
Date of Registration in DRKS: 2015/01/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
PLEASE NOTE: This trial has been registered retrospectively.
Trial Description
Title
Stenosis of arteries supplying the gastric tube as potential risk factor for
anastomotic leakage in patients with esophageal carcinoma after Ivor-Lewis
esophagectomy
Trial Acronym
[---]*
URL of the trial
[---]*
Brief Summary in Lay Language
En-bloc resection of the esophagus and reconstruction by gastric pull-up and
intrathoracic anastomosis is still associated with high morbidity and mortality in
patients with esophageal cancer. Postoperative complications are mainly due to
anastomotic leakage. Insufficiency of the esophagogastrostomy is primarily
caused by reduced vascularization and consecutive ischemia of the anastomosed
gastric
fundus. Atherosclerosis is a known cause of
ischemia and arteriosclerotic plaques of the celiac trunk and arteria mesenterica
superior might compromise the blood supply of the
gastric tube and esophagogastrostomy. This study is designed to detect the
incidence of arteriosclerotic plaques of the mentioned arteries in routine
preoperative staging computer tomography and to answer the question whether
or not stenosis of the celiac trunk and the arteria mesenterica superior correlate
with the occurence of anastomotic leakage after esophagectomy in cancer
patients.
Brief Summary in Scientific Language
The question whether arteriosclerotic stenosis of the celiac trunk and the arteria
mesenterica superior detected by routine preoperative computer tomography
influence the occurence of anastomotic leakage after Ivor-Lewis-esophagectomy in
patients with esophageal cancer is not answered. The aim of this prospective
study will be to give an answer on incidence of stenosis of the mentioned arteries.
Furthermore the study should answer wether a quantification of stenosis is
possible and wether the occurence of stenosis correlate with anastomotic leakage
after esophagectomy or not.
Organizational Data
DRKS-ID: DRKS00007701
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DRKS-ID: DRKS00007701
Date of Registration in DRKS: 2015/01/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
DRKS-ID: DRKS00007701
Date of Registration in DRKS: 2015/01/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 14-303 , Ethik-Kommission der Medizinischen Fakultät
der Universität zu Köln
Secondary IDs
Health condition or Problem studied
ICD10: C15.9 - Malignant neoplasm: Oesophagus, unspecified
ICD10: K91.83 - [generalization K91.8: Other postprocedural disorders of
digestive system, not elsewhere classified]
Interventions/Observational Groups
Arm 1: Examination of the celiac trunc, its branches and the arteria mesenterica
superior by computer tomography on arteriosclerotic stenosis in patients with
esophageal cancer before planned curative surgical treatment and potential
correlation between stenosis and the occurence of anastomotic leakage after
surgery.
Characteristics
Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: [---]*
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Prevention
Assignment: Single (group)
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
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DRKS-ID: DRKS00007701
Date of Registration in DRKS: 2015/01/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
Primary Outcome
anastomotic leakage
Secondary Outcome
mortality
Countries of recruitment
DE Germany
Locations of Recruitment
University Medical Center Klinik und Poliklinik für Allgemein-, Viszeral- und
Tumorchirurgie, Köln
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2014/01/06
Target Sample Size: 200
Monocenter/Multicenter trial: Monocenter trial
National/International: National
Inclusion Criteria
Gender: Both, male and female
Minimum Age: no minimum age
Maximum Age: no maximum age
Additional Inclusion Criteria
Patients with esophageal cancer and planned curative surgery ( transthoracic
esophagectomy and reconstruction by gastric pull-up and intrathoracic
esophagogastrostomy)
Exclusion criteria
None
Addresses
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DRKS-ID: DRKS00007701
Date of Registration in DRKS: 2015/01/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
Primary Sponsor
Universitätsklinikum Köln
Mr. Prof. Dr. med. Wolfgang Schröder
Kerpener Str. 62
50937 Köln
Germany
Telephone: 0221-4784803
Fax: [---]*
E-mail: wolfgang.schroeder at uni-koeln.de
URL: www.medizin.uni-koeln.de
Contact for Scientific Queries
Klinik und Poliklinik für Allgemein-, Viszeral- und Tumorchirurgie;
Universitätsklinikum Köln
Mr. Prof. Dr. med. Wolfgang Schröder
Kerpener Straße 62
50937 Köln
Germany
Telephone: 0221-478-4803
Fax: [---]*
E-mail: wolfgang.schroeder at uni-koeln.de
URL: [---]*
Contact for Public Queries
Klinik und Poliklinik für Allgemein-, Viszeral- und Tumorchirurgie;
Universitätsklinikum Köln
Mr. Dr. med. Sebastian Brinkmann
Kerpener Straße 62
50937 Köln
Germany
Telephone: 0221-478-4803
Fax: [---]*
E-mail: sebastian.brinkmann at uk-koeln.de
URL: [---]*
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
Klinik für Allgemein-, Viszeral- und TumorchirurgieUniversitätsklinik Köln
Kerpener Straße 62
50937 Köln
Germany
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DRKS-ID: DRKS00007701
Date of Registration in DRKS: 2015/01/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
Institutional budget, no external funding (budget of sponsor/PI)
Klinik für Allgemein-, Viszeral- und TumorchirurgieUniversitätsklinik Köln
Kerpener Straße 62
50937 Köln
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
* This entry means the parameter is not applicable or has not been set.
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