Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

Anastomotic Leak Clinical Trial

Official title:

Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606822
• Other study ID #: 2021.0457
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Roos Pouw, MD, PhD
• Phone: +3120 4444444
• Email: r.e.pouw[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are:

• What is the success rate of EVT for transmural defects in the upper GI tract?

• What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics)

• What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treated with EVT for anastomotic leakage after esophago-gastric surgery

• Signed informed consent form

• 18 years or older

Exclusion Criteria:

• No signed informed consent

Related Conditions & MeSH terms

• Anastomotic Leak
• Esophageal Perforation

Intervention

Other:
• Observational
Collection of data from electronic health record

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Centers, location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate		1-3 years
Secondary	Mortality		1-3 years
Secondary	Adverse events		1-3 years
Secondary	Treatment specifics	Including number of EVT-related endoscopies, number of used sponges/VACStents	1-3 years
Secondary	Treatment specifics	Including days between exchanges, duration of treatment in days, hospital stay in days, ICU stay in days	1-3 years