Detection of Anastomotic Leakage After Esophageal Surgery
Primary Purpose
Esophageal Cancer, Anastomotic Leakage
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Contrast swallow radiography, endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophageal Cancer focused on measuring detection of anastomotic leakage, esophageal resection, diagnostic safety
Eligibility Criteria
Inclusion Criteria:
- Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
Exclusion Criteria:
- no transthoracic resection
- no primary anastomosis
- recurrent disease
- refusal to participate
Sites / Locations
- Department of Surgery, University of Heidelberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
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.
Outcomes
Primary Outcome Measures
Detection of anastomotic leakage
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642525
Brief Title
Detection of Anastomotic Leakage After Esophageal Surgery
Official Title
Radiologic vs. Endoscopic Evaluation of the Conduit After Esophageal Resection: a Prospective, Blinded, Intraindividual Controlled Diagnostic Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Anastomotic Leakage
Keywords
detection of anastomotic leakage, esophageal resection, diagnostic safety
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Contrast swallow radiography, endoscopy
Intervention Description
Contrast swallow radiography is performed using water soluble contrast medium Esophagoscopy is performed according to standard safety guidelines
Primary Outcome Measure Information:
Title
Detection of anastomotic leakage
Time Frame
5-7 days after surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with primary esophageal cancer undergoing transthoracic esophagectomy.
Exclusion Criteria:
no transthoracic resection
no primary anastomosis
recurrent disease
refusal to participate
Facility Information:
Facility Name
Department of Surgery, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Detection of Anastomotic Leakage After Esophageal Surgery
We'll reach out to this number within 24 hrs