Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT02751333
Status:
WITHDRAWN
Last Update Posted:
2017-05-15
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment in the Management of Benign Esophageal Pathology: A Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The reason was the fact that the study was not clinically feasible.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: