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NCT Number: NCT05606822

Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Centers, location VUmc

Amsterdam, Netherlands

Location status: Recruiting

Location contact

Lisanne Pattynama, MD

SUB_INVESTIGATOR

Roos Pouw, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Collection of data from electronic health record

Primary outcomes

  1. Success rate

    Time frame: 1-3 years

    Successful treatment of EVT for the upper GI defect: closure confirmed via endoscopy

Secondary outcomes

  1. Mortality

    Time frame: 6 months (due to possible prolonged hospital stay)

    30-day and in-hospital mortality, relation to EVT

  2. Adverse events

    Time frame: 6 months

    (Severe) adverse events related to EVT

  3. Treatment cycles

    Time frame: 6 months

    Including number of EVT-related endoscopies, number of used sponges/VACStents

  4. Duration of treatment

    Time frame: 6 months

    Including duration of treatment in days, hospital stay in days, ICU stay in days

Study contacts

Contact information is provided by the study sponsor or research team.

Lisanne Pattynama, MD

CONTACT

[email protected]

+3120 4444444

Roos Pouw, MD, PhD

CONTACT

[email protected]

+3120 4444444

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Nov 7, 2022
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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