Non-invasive Detection of Anastomotic Leakage

Anastomotic Leak Clinical Trial

Official title:

Non-invasive Detection of Anastomotic Leakage Following Esophageal and Pancreatic Surgery by Urinary Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203434
• Other study ID #: 2014.543
• Status: Completed
• Phase: N/A
• First received: June 27, 2017
• Last updated: June 28, 2017
• Start date: January 1, 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: June 2017
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Anastomotic Leak

Intervention

Diagnostic Test:
• Urinary volatile organic compound analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic leakage		Postoperatively (30-days)