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

NCT ID: NCT05899504

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-01-01

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.

Conditions

Migration of Implant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

(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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ovesco Endoscopy AG

INDUSTRY

Sponsor Role: collaborator

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pradev Innovulu, MD

Role: CONTACT

pradev32@gmail.com

9182645727

Other Identifiers

NOTSC-01

Identifier Type: -

Identifier Source: org_study_id