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

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05899504

Collaborator

Ovesco Endoscopy AG (Industry)

108

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migration of Implant	Device: Over-The-Scope-Clip (OTSC) Stent Fix	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 migrationA 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 (Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (Interventional) Patients undergoing Esophageal stenting with over the scope clip (OTSC) stent fix 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 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
No Intervention: (Non- Interventional) Participants undergoing Esophageal stenting without OTSC stent fix This will be the standard procedure of esophageal stent placement under fluro imaging/screening

Arm

Intervention/Treatment

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

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

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

No Intervention: (Non- Interventional) Participants undergoing Esophageal stenting without OTSC stent fix

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

Outcome Measures

Primary Outcome Measures

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

Procedural time in minutes [immediately after procedure]
Total time required to complete the intended procedure
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asian Institute of Gastroenterology, India
Ovesco Endoscopy AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asian Institute of Gastroenterology, India

ClinicalTrials.gov Identifier:

NCT05899504

Other Study ID Numbers:

NOTSC-01

First Posted:

Jun 12, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 12, 2023