The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration
- Conditions
- Migration of Implant
- Registration Number
- NCT05899504
- Lead Sponsor
- Asian Institute of Gastroenterology, India
- Brief Summary
New endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration.
- Detailed Description
Participants requiring esophageal SEMS placement for various indications such as stricture (benign, malignant), leaks All participants who require esophageal SEMS placement. Esophago-gastroscopy will be done to assess the feasibility of SEMS placement.
Participants are randomized into two arms- one arm (interventional) use of OTSC stent fix after esophageal SEMS placement or the other arm (non-interventional) esophageal SEMS is placed.
Participants are followed up for 1 year to observe stent migration rate in both the groups.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 108
- All adults (18+ years)
- Have benign, malignant non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
- Ability to consent to stent fixation.
- Patients aged under 18 years of age
- Unable to provide informed consent
- Inherited or acquired coagulopathy likely to affect the risk of bleeding
- Receiving anticoagulant therapy that could not be stopped or bridged prior to procedure
- Breast feeding, pregnant and lactating women's.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Esophageal SEMS migration rate at 4 weeks follow up. 4 weeks Proportion of patients experiencing stent migration at 4 weeks after index procedure.
- Secondary Outcome Measures
Name Time Method Migration of stent in both groups 6 months Time to migration after stent placement in respective groups
Adverse events in both groups apart from stent migration 6 months All the adverse events will be recorded, excluding SEMS migration, which is already an primary outcome measure separately
Improvement in dysphagia score 1 week Improvement in dysphagia score at one week post procedure in both the arms
Procedural time in minutes immediately after procedure Total time required to complete the intended procedure