Trial document




This trial has been registered retrospectively.
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  DRKS00007701

Trial Description

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Title

Stenosis of arteries supplying the gastric tube as potential risk factor for anastomotic leakage in patients with esophageal carcinoma after Ivor-Lewis esophagectomy

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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.

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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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007701
  •   2015/01/30
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  •   yes
  •   Approved
  •   14-303, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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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]
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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.
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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
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Primary Outcome

anastomotic leakage

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Secondary Outcome

mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/06
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Patients with esophageal cancer and planned curative surgery ( transthoracic esophagectomy and reconstruction by gastric pull-up and intrathoracic esophagogastrostomy)

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Exclusion Criteria

None

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Köln
    • Mr.  Prof. Dr. med.  Wolfgang  Schröder 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Allgemein-, Viszeral- und Tumorchirurgie; Universitätsklinikum Köln
    • Mr.  Prof. Dr. med.  Wolfgang  Schröder 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Allgemein-, Viszeral- und Tumorchirurgie; Universitätsklinikum Köln
    • Mr.  Dr. med.  Sebastian  Brinkmann 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und TumorchirurgieUniversitätsklinik Köln
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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