NCT02751333

Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Esophageal stents are commonly used for benign esophageal pathology, especially strictures or esophageal mucosal defects such as leaks, fistulae, or perforations. The major limiting factor to stent placement is the high migration rate of the stent. Investigators are trying to prospectively evaluate the efficacy of endostitch in preventing stent migration in benign esophageal disease in comparison with standard, fully covered self-expanding metal stents (FCSEMS) placement without fixation.

Detailed description

The use of removable, fully covered self-expanding metal stents (FCSEMS) in the management of benign esophageal pathology has been increasingly applied in recent years. Several studies have shown promising results with its application in esophageal perforation, fistula, or leak, and refractory benign strictures. However, the major limiting factor to successful treatment with FCSEMS in this setting is the substantial migration rates. Different strategies has been used to secure esophageal stents but to little success. Several tertiary institutions including investigators have adopted the use of endostitch (ES) with the OverStitchTM system (Apollo Endosurgery, Austin, Texas) as the preferred method for stent fixation. Animal ex-vivo studies have confirmed the greater anchoring ability and tensile strength with this method when compared to esophageal stenting alone or with through the endoscope clip fixation while retrospective series have shown promising results with lower rates of stent migration when compared to conventional stent insertion. However, although the use of endostitch stent fixation has been used in several centers in the United-States with strong retrospective data (including investigators data), no prospective randomized controlled trial have confirmed its effectiveness in preventing stent migration.

Conditions

• Esophageal Strictures
• Esophageal Leak
• Esophageal Perforation
• Esophageal Fistula
• Endostitch
• Esophageal Stent

Interventions

Type	Name	Description
PROCEDURE	FCSEMS with Endostitch (ES)	The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
PROCEDURE	FCSEMS with No Suturing (NS)	The insertion of FCSEMS with no suturing.
DEVICE	Fully Covered Self-Expanding Metal Stents (FCSEMS)	This is the stent that will be used to treat the esophageal pathology in both groups
DEVICE	EndoStitch (ES) with the OverStitchTM system	This is the device used to apply the stitches to the stent in participants randomized to stent suturing.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-04-26
• Last updated: 2017-05-15

Locations

1 site across 1 country: United States