Non-invasive Detection of Anastomotic Leakage

NCT03203434 | Completed

• 1 other identifier: 2014.543
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anastomotic Leak

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage

  Postoperatively (30-days)

Study Arms (4)

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

Interventions

Urinary volatile organic compound analysis DIAGNOSTIC_TEST

Esophageal anastomotic leakage; Esophageal uncomplicated controls; Pancreatic anastomotic leakage; Pancreatic uncomplicated controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Anastomotic Leak; Pancreatic Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Freek Daams, MD PhD

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 29, 2017
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share