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OpenTrials
Completed

NCT Number: NCT04571541

Endoscopic Management of Esophageal Wall Defects

The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

About this study

Esophageal wall defects are a rare but potentially life-threatening subset of luminal pathology which usually require timely intervention in order to reduce the known associated high morbidity and mortality. These defects can be due to surgical and endoscopic procedures, such as post-operative leaks and fistulas and perforations complicating endoscopic dilation. In addition, defects can occur spontaneously due to Boerhaave's syndrome or following chemoradiation treatments of esophageal or other chest malignancies. Surgical management was historically the mainstay of therapy for these defects with conservative management remaining an alternative in poor surgical candidates. Over the last several years however, interventional endoscopy has played an increasing role in treatment of esophageal wall defects, with endoscopic stenting quickly becoming a viable alternative. Temporary stents including the fully covered self-expandable metal stents (FC-SEMS), partially covered self-expandable metal stents (P-SEMS) and self-expandable plastic stents (SEPS) have all been successfully used and have become increasingly regarded as the new standard of care.

Indiana University is a tertiary referral center is a destination for complex thoracic surgery, oncology and esophageal disease referrals. The innovative luminal endoscopy team started employing a several modalities including flexible endoscopic suturing and stenting to close esophageal defects. To our knowledge, there is a dearth of data on outcomes associated with multi-modality esophageal defect closure techniques and little to no data comparing this approach to the current standard of care of stenting alone or surgery.

Who can participate

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

Inclusion criteria

  • Any patient with spontaneous or iatrogenic esophageal wall defect

Exclusion criteria

  • None

Treatment and study plan

Stenting

Device

Effect of endoscopic stenting on healing of esophageal wall defects

Primary outcomes

  1. Resolution of esophageal wall defect

    Time frame: 7/1/2014 to 7/1/2022

    Resolution of esophageal wall defect

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Outcomes of Endoscopic Management of Esophageal Wall Defects at a Large Referral Center

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2020
Registry last updated
Feb 18, 2026

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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