Non-invasive Detection of Anastomotic Leakage

Completed

• Conditions: Anastomotic Leak
• Interventions: Diagnostic Test: Urinary volatile organic compound analysis

• Registration Number: NCT03203434
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

Esophagectomy or pancreaticoduodenectomy is the standard surgical approach for patients with malignant tumors of the esophagus or pancreatic head. These procedures are associated with high morbidity rates, which are strongly correlated with the occurrence of anastomotic leakage. Current diagnostic methods, including clinical, biochemical and radiological techniques are frequently inconclusive. Delay in diagnosis leads to delay in treatment, which ratifies the need for development of novel and accurate non-invasive diagnostic tests for detection of anastomotic leakage. Urinary volatile organic compounds reflect the metabolic status of an individual, which is associated with a systemic immunological response. The aim of this study was to determine the diagnostic accuracy of urinary volatile organic compounds to detect anastomotic leakage after esophagectomy or pancreaticoduodenectomy in an early phase.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Last Update Submitted: 2017-06-28
• Study First Posted: 2017-06-29
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients were aged 18-90 years
• American Society of Anesthesiologists (ASA) physical status of 3 or lower
• All participants were capable to understand the study information and signed written informed consent

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophageal uncomplicated controls	Urinary volatile organic compound analysis	-
Pancreatic uncomplicated controls	Urinary volatile organic compound analysis	-
Pancreatic anastomotic leakage	Urinary volatile organic compound analysis	-
Esophageal anastomotic leakage	Urinary volatile organic compound analysis	-

Primary Outcome Measures

Name	Time	Method
Anastomotic leakage	Postoperatively (30-days)