The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration (NOTSC-01)

Asian Institute of Gastroenterology, India

Status: Not yet enrolling

Conditions: Migration of Implant

Treatments: Device: Over-The-Scope-Clip (OTSC) Stent Fix

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05899504

NOTSC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

(Interventional) Patients undergoing Esophageal stenting with over the scope clip (OTSC) stent fix

Experimental group

Description:

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.

Treatment:

Device: Over-The-Scope-Clip (OTSC) Stent Fix

(Non- Interventional) Participants undergoing Esophageal stenting without OTSC stent fix

No Intervention group

Description:

This will be the standard procedure of esophageal stent placement under fluro imaging/screening