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Non-invasive Detection of Anastomotic Leakage

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03203434
Enrollment
66
Registered
2017-06-29
Start date
2015-01-01
Completion date
2017-03-01
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak

Keywords

Pancreatic cancer, Esophageal cancer, volatile organic compounds, Field asymmetric ion mobility spectrometry

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.

Interventions

DIAGNOSTIC_TESTUrinary volatile organic compound analysis

Sponsors

Amsterdam UMC, location VUmc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Anastomotic leakagePostoperatively (30-days)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026