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

Asian Institute of Gastroenterology, India108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

108

Conditions

Migration of Implant

Interventions

Over-The-Scope-Clip (OTSC) Stent FixDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Esophageal SEMS migration rate at 4 weeks follow up.

Proportion of patients experiencing stent migration at 4 weeks after index procedure.

Time frame: 4 weeks

Secondary Outcomes

Procedural time in minutes

Total time required to complete the intended procedure

Time frame: immediately after procedure

Migration of stent in both groups

Time to migration after stent placement in respective groups

Time frame: 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

Time frame: 6 months

Improvement in dysphagia score

Improvement in dysphagia score at one week post procedure in both the arms

Time frame: 1 week

Central Contacts

Pradev Innovulu, MD

CONTACT

9182645727 pradev32@gmail.com

Data from ClinicalTrials.gov

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