Endoscopic Management of Esophageal Wall Defects

Esophageal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571541
• Other study ID #: 1509223988
• Status: Recruiting
• Start date: July 1, 2014
• Est. completion date: July 1, 2025

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: Martha Mendez
• Email: mwmendez[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient with spontaneous or iatrogenic esophageal wall defect

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Esophageal Fistula
• Esophageal Perforation
• Fistula

Intervention

Device:
• Stenting
Effect of endoscopic stenting on healing of esophageal wall defects

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of esophageal wall defect	Resolution of esophageal wall defect	7/1/2014 to 7/1/2022