Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Leak; Esophageal Perforation; Endoscopic Vacuum Therapy; Esophageal Perforation, Traumatic; EsoSponge; VACStent
• Intervention / Treatment: Other: Observational

Detailed Description

Transmural defects in the upper gastrointestinal (GI) tract are defined as a disruption or injury extending through all layers of the oesophageal or gastric wall. These defects can result from various causes, including anastomotic leakage (AL) after oesophago-gastric surgery, iatrogenic perforation, Boerhaave syndrome, or trauma. Transmural defects in the upper GI tract are associated with serious consequences, such as leakage of saliva, gastric contents, and bile into the mediastinum, triggering an inflammatory response. Untreated or inadequately managed mediastinitis can lead to serious morbidity, sepsis, and mortality. Therefore, timely diagnosis and treatment of these defects is crucial. There are several treatment options for transmural defects in the upper GI tract. Conservative management involves a nil by mouth protocol, antibiotics, and (percutaneous) drainage. Endoscopic treatments include self-expandable metallic stents (SEMS), through-the-scope clips, over-the-scope clips, suturing with overstitch, and most recently, endoscopic vacuum therapy (EVT). Historically, SEMS has been the most used treatment option for transmural defects in the upper GI tract. However, persisting leakage and complications such as dislocation of the stent are not uncommon. Besides that, not all defects are suitable for stenting and additional percutaneous drainage is often necessary, but not always possible. Surgical treatment, such as a re-anastomosis or resection of the gastric conduit with construction of a cervical esophagostomy is generally required in severely septic patients. The choice of treatment depends on factors such as the location and size of the leakage, severity of symptoms, and presence of conduit ischemia or necrosis. In the past decade, EVT has been established as an effective and safe endoscopic treatment option, and it was found to be superior in terms of success rate in AL healing compared to other treatments. However, the implementation of EVT in clinical practice might be hindered by multiple challenges and questions regarding indications and techniques. This study aims to answer remaining questions and bundle expertise, to be able to determine the best indications and techniques of EVT, to reach the full potential of the treatment.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Roos Pouw, MD, PhD; Phone Number: +3120 4444444; Email: r.e.pouw@amsterdamumc.nl
• Study Contact Backup: Name: Lisanne Pattynama, MD; Phone Number: +3120 4444444; Email: l.m.pattynama@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam University Medical Centers, location VUmc
    • Contact: Roos Pouw, MD, PhD; Email: r.e.pouw@amsterdamumc.nl
    • Sub-Investigator: Lisanne Pattynama, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy	1-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30-day and in-hospital mortality, relation to EVT	6 months (due to possible prolonged hospital stay)
Adverse events	(Severe) adverse events related to EVT	6 months
Treatment cycles	Including number of EVT-related endoscopies, number of used sponges/VACStents	6 months
Duration of treatment	Including duration of treatment in days, hospital stay in days, ICU stay in days	6 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Roos Pouw, MD, PhD, Amsterdam University Medical Center, location VU

Publications and helpful links

Helpful Links

• Pattynama, L. M. D. et al (2024). Multi-modality management of defects in the gastrointestinal tract: Where the endoscope meets the scalpel: Endoscopic vacuum therapy in the upper gastrointestinal tract

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Wounds and Injuries; Gastrointestinal Diseases; Esophageal Diseases; Anastomotic Leak; Esophageal Perforation
• Other Study ID Numbers: 2021.0457

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No