Trial document
This trial has been registered retrospectively.
DRKS00007701
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
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URL of the Trial
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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
- DRKS00007701
- 2015/01/30
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- yes
- Approved
- 14-303, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
Secondary IDs
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Health Condition or Problem studied
- C15.9 - Malignant neoplasm: Oesophagus, unspecified
- K91.83 - [generalization K91.8: Other postprocedural disorders of digestive system, not elsewhere classified]
Interventions/Observational Groups
- 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
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Prevention
- Single (group)
- N/A
- N/A
Primary Outcome
anastomotic leakage
Secondary Outcome
mortality
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2014/01/06
- 200
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum 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
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Köln
- Mr. Prof. Dr. med. Wolfgang Schröder
- Kerpener Str. 62
- 50937 Köln
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0221-4784803
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- wolfgang.schroeder at uni-koeln.de
- http://www.medizin.uni-koeln.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik und Poliklinik für Allgemein-, Viszeral- und Tumorchirurgie; Universitätsklinikum Köln
- Mr. Prof. Dr. med. Wolfgang Schröder
- Kerpener Straße 62
- 50937 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0221-478-4803
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- wolfgang.schroeder at uni-koeln.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik und Poliklinik für Allgemein-, Viszeral- und Tumorchirurgie; Universitätsklinikum Köln
- Mr. Dr. med. Sebastian Brinkmann
- Kerpener Straße 62
- 50937 Köln
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0221-478-4803
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- sebastian.brinkmann at uk-koeln.de
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end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Klinik für Allgemein-, Viszeral- und TumorchirurgieUniversitätsklinik Köln
- Kerpener Straße 62
- 50937 Köln
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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