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Non-invasive Detection of Anastomotic Leakage

A

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Anastomotic Leak

Treatments

Diagnostic Test: Urinary volatile organic compound analysis

Study type

Observational

Funder types

Other

Identifiers

NCT03203434
2014.543

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

66 participants in 4 patient groups

Esophageal anastomotic leakage
Treatment:
Diagnostic Test: Urinary volatile organic compound analysis
Esophageal uncomplicated controls
Treatment:
Diagnostic Test: Urinary volatile organic compound analysis
Pancreatic anastomotic leakage
Treatment:
Diagnostic Test: Urinary volatile organic compound analysis
Pancreatic uncomplicated controls
Treatment:
Diagnostic Test: Urinary volatile organic compound analysis

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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