Non-invasive Detection of Anastomotic Leakage

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

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.

Study Overview

• Status: Completed
• Conditions: Anastomotic Leak
• Intervention / Treatment: Diagnostic test: Urinary volatile organic compound analysis

• Study Type: Observational
• Enrollment (Actual): 66

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants had suspected malignancies of the esophagus, pancreas, distal bile duct, ampulla Vateri or duodenum and were scheduled for surgery (i.e. esophagectomy or pancreaticoduodenectomy).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Esophageal anastomotic leakage	Diagnostic test: Urinary volatile organic compound analysis
Esophageal uncomplicated controls	Diagnostic test: Urinary volatile organic compound analysis
Pancreatic anastomotic leakage	Diagnostic test: Urinary volatile organic compound analysis
Pancreatic uncomplicated controls	Diagnostic test: Urinary volatile organic compound analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anastomotic leakage	Postoperatively (30-days)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Study Director: Freek Daams, MD PhD, Amsterdam Umc, Location Vumc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Pancreatic cancer; Esophageal cancer; volatile organic compounds; Field asymmetric ion mobility spectrometry
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: 2014.543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No