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

Study Overview
=================
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.

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

Conditions
-----------------
Migration of Implant

Intervention / Treatment
-----------------
* Device: Over-The-Scope-Clip (OTSC) Stent Fix


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (Interventional) Patients undergoing Esophageal stenting with over the scope clip (OTSC) stent fix<br>Marking clips will be placed with endoscopy at the upper end of the stricture. In mild stricture cases that allowed the passage of the endoscope, marking clips will also placed in the lower end. A stent that of at least 4 cm longer than the stricture will be used to allow at least a 2-cm extension above and below the proximal and distal tumor margins. The stent positioned over a guidewire and deployed under fluoroscopy guidance and, in some cases, also under endoscopy guidance. Subsequently, the OTSC system will be loaded onto the scope and part of the upper rim of the stent will be suctioned into the transparent cap before releasing the OTSC, grasping both the SEMS and esophageal wall. Investigator will avoid deploying the OTSC in areas of pulsations to prevent potential grasping of the vasculature structure. Only a single OTSC will be placed per participants. | Device: Over-The-Scope-Clip (OTSC) Stent Fix<br>* A stent that of at least 4 cm longer than the stricture will be used to allow at least a 2-cm extension above and below the proximal and distal tumor margins. The stent positioned over a guidewire and deployed under fluoroscopy guidance and, in some cases, also under endoscopy guidance. Subsequently, the OTSC system will be loaded onto the scope and part of the upper rim of the stent will be suctioned into the transparent cap before releasing the OTSC, grasping both the SEMS and esophageal wall. We will avoid deploying the OTSC in areas of pulsations to prevent potential grasping of the vasculature structure<br>|
| No Intervention: (Non- Interventional) Participants undergoing Esophageal stenting without OTSC stent fix<br>This will be the standard procedure of esophageal stent placement under fluro imaging/screening | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal SEMS migration rate at 4 weeks follow up. | Proportion of patients experiencing stent migration at 4 weeks after index procedure. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural time in minutes | Total time required to complete the intended procedure | immediately after procedure | 
| Migration of stent in both groups | Time to migration after stent placement in respective groups | 6 months | 
| Adverse events in both groups apart from stent migration | All the adverse events will be recorded, excluding SEMS migration, which is already an primary outcome measure separately | 6 months | 
| Improvement in dysphagia score | Improvement in dysphagia score at one week post procedure in both the arms | 1 week |