Skip to content

Endoscopic Management of Esophageal Wall Defects

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04571541
Enrollment
150
Registered
2020-10-01
Start date
2014-07-01
Completion date
2025-07-01
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Fistula, Esophageal Perforation

Brief summary

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.

Detailed description

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.

Interventions

DEVICEStenting

Effect of endoscopic stenting on healing of esophageal wall defects

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Any patient with spontaneous or iatrogenic esophageal wall defect

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Resolution of esophageal wall defect7/1/2014 to 7/1/2022Resolution of esophageal wall defect

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026