The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration

The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration- Randomized Controlled Trial- A Pilot Study

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.