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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 FixDevice

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

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Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

INVESTIGATOR

Purpose

PREVENTION

Intervention Model

PARALLEL

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

Sponsor Type

OTHER

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

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

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record