Clinical Trial: Esophageal Stent Migration With Endoscopic Suture Fixation Compared to Standard Deployment

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Johns Hopkins University

Current Primary Outcome: Number of participants with Stent Migration as assessed by Symptoms suggestive of stent migration or objective evidence of migration on radiological imaging or endoscopy. [ Time Frame: Up to 6 months ]

Subjects returning to the hospital following stent placement with symptoms suggestive of stent migration such as fever, abdominal or chest pain, nausea/vomiting, and dysphagia with objective evidence of stent migration either on radiological imaging or endoscopy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical success of stent deployment as assessed by the relief of the pre-stent dysphagia [ Time Frame: 4 weeks, 6 months post-stent removal ]
    Dysphagia relief as assessed by the validated dysphagia score
  • Procedure time [ Time Frame: During procedure ]
    Time required for stent placement with/without endostitch
  • Stent insertion complication rate [ Time Frame: 3 days post-stent insertion, 4 weeks post-stent removal ]
    All complications related to stent insertion other than stent migration will be recorded with a preset questionnaire to measure the frequency of complications related to stent insertion.
  • Quality of life [ Time Frame: prior to stent insertion and 6 months post-stent removal ]
    Quality of life as measured by the SF-36 (Short Form health survey) questionnaire


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: April 18, 2016
Date Started: March 2016
Date Completion:
Last Updated: May 11, 2017
Last Verified: May 2017