NCT05899504

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-06-12
• Last updated: 2023-06-12