Detection of Anastomotic Leakage After Esophageal Surgery

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00642525
First received: March 19, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention
Esophageal Cancer
Anastomotic Leakage
Procedure: Contrast swallow radiography, endoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Detection of anastomotic leakage [ Time Frame: 5-7 days after surgical procedure ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: January 2006
Study Completion Date: October 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642525

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

No publications provided

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
Study First Received: March 19, 2008
Last Updated: March 19, 2008
Health Authority: Ethics Commission, Heidelberg: Germany

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

ClinicalTrials.gov processed this record on July 20, 2014