Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ovesco Endoscopy AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (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. |
|
| (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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pradev Innovulu, MD | Contact | 9182645727 | pradev32@gmail.com |
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
|
| 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 |