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Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

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ClinicalTrials.gov Identifier: NCT05606822
Recruitment Status : Recruiting
First Posted : November 7, 2022
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Roos Pouw, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Endoscopic Vacuum Therapy Anastomotic Leak Esophageal Perforation Esophageal Perforation, Traumatic EsoSponge VACStent Other: Observational

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Endoscopic Vacuum Therapy for Anastomotic Leakage After Upper Gastrointestinal Surgery / Endoscopic Vacuum Therapy for Esophageal Perforation: A Multicenter Retrospective Cohort Study
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Anastomotic leakage after gastrointestinal surgery
No interventions will be administered, as this is an observational study.
 Other: Observational
Collection of data from electronic health record
Esophageal perforation (Boerhaave syndrome, iatrogenic, trauma, other)
No interventions will be administered, as this is an observational study.
 Other: Observational
Collection of data from electronic health record


Outcome Measures
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Primary Outcome Measures :
  1. Success rate [ Time Frame: 1-3 years ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1-3 years ]
  2. Adverse events [ Time Frame: 1-3 years ]
  3. Treatment specifics [ Time Frame: 1-3 years ]
    Including number of EVT-related endoscopies, number of used sponges/VACStents

  4. Treatment specifics [ Time Frame: 1-3 years ]
    Including days between exchanges, duration of treatment in days, hospital stay in days, ICU stay in days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients treated with EVT for a transmural defect in the upper GI tract, including anastomotic leakage, Boerhaave syndrome, iatrogenic perforations, trauma, etc.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05606822


Contacts
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Contact: Roos Pouw, MD, PhD +3120 4444444 r.e.pouw@amsterdamumc.nl
Contact: Lisanne Pattynama, MD +3120 4444444 l.m.pattynama@amsterdamumc.nl

Locations
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Netherlands
Amsterdam University Medical Centers, location VUmc Recruiting
Amsterdam, Netherlands
Contact: Roos Pouw, MD, PhD       r.e.pouw@amsterdamumc.nl   
Sub-Investigator: Lisanne Pattynama, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: Roos Pouw, Principle Investigator, Doctor of Medicine, Doctor of Philosophy, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT05606822    
Other Study ID Numbers: 2021.0457
First Posted: November 7, 2022    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Perforation
Anastomotic Leak
Postoperative Complications
Pathologic Processes
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Wounds and Injuries