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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migration of Implant
• Intervention / Treatment: Device: Over-The-Scope-Clip (OTSC) Stent Fix

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 Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pradev Innovulu, MD; Phone Number: 9182645727; Email: pradev32@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Collaborators: Ovesco Endoscopy AG

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NOTSC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No