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

NCT05899504 | Unknown

• 1 other identifier: NOTSC-01
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Migration of Implant

Outcome Measures

Primary Outcomes (1)

• Esophageal SEMS migration rate at 4 weeks follow up.

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

  4 weeks

Secondary Outcomes (4)

• Procedural time in minutes

  immediately after procedure

• Migration of stent in both groups

  6 months

• Adverse events in both groups apart from stent migration

  6 months

• Improvement in dysphagia score

  1 week

Study Arms (2)

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

EXPERIMENTAL

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

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

NO INTERVENTION

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead
• Ovesco Endoscopy AG: collaborator

Central Study Contacts

Pradev Innovulu, MD

CONTACT

9182645727; pradev32@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 migration

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-06