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Detection of Anastomotic Leakage After Esophageal Surgery

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ClinicalTrials.gov Identifier: NCT00642525
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : March 25, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Anastomotic leakage is a major complication in esophageal surgery. Although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. This is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

Condition or disease Intervention/treatment
Esophageal Cancer Anastomotic Leakage Procedure: Contrast swallow radiography, endoscopy

Detailed Description:
This prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. The investigators will not be aware of the results of the corresponding examination. Sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
Study Start Date : January 2006
Primary Completion Date : September 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
A prospective, blinded, intraindividual controlled study is conducted with patients with transthoracic esophagectomy due to esophageal cancer. A radiographic contrast study is performed prior to endoscopy at the 5th to 7th postoperative day.
Procedure: Contrast swallow radiography, endoscopy
Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines


Outcome Measures

Primary Outcome Measures :
  1. Detection of anastomotic leakage [ Time Frame: 5-7 days after surgical procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary esophageal cancer undergoing transthoracic esophagectomy.

Exclusion Criteria:

  • no transthoracic resection
  • no primary anastomosis
  • recurrent disease
  • refusal to participate
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642525


Locations
Germany
Department of Surgery, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
More Information

Responsible Party: Jens Werner, MD Professor of Surgery, Department of Surgery, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00642525     History of Changes
Other Study ID Numbers: Endoray
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008

Keywords provided by Heidelberg University:
detection of anastomotic leakage
esophageal resection
diagnostic safety

Additional relevant MeSH terms:
Esophageal Neoplasms
Anastomotic Leak
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes