Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration

Study Overview
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Brief Summary
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In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Herein the investigators suggest newly method to prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent stent migration. But it is difficult to remove stent after resolved stricture. So the investigators add the suture between hemoclip and stent. And the investigators cut the suture when stent removal.

Official Title
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The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study

Conditions
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Gastroduodenal Anastomosis

Intervention / Treatment
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* Procedure: deployment of through the scope covered metallic stent at the stricture site
* Device: Covered Self-expandable Metallic Stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subtotal gastrectomy with Billroth-I or Billroth-II anastomosis symptom of gastric outlet obstruction anastomosis site stricture after surgery Exclusion Criteria: patients of the impossible stent insertion due to other complication foreigner no agree a concent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anastomosis site stricture<br>anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis | Procedure: deployment of through the scope covered metallic stent at the stricture site<br>* Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site<br>Device: Covered Self-expandable Metallic Stents<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of symptom (Resolving anastomosis site stricture) | Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet. | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications associated with the procedure | Check all the complications associated with the procedure (e.g. procedure failure, stent migration, no improvement of symptom, etc.) | Up to 1 month (time of stent removal) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastomosis site structure, Stent insertion, Stent migration