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

Not Applicable

Completed

• Conditions: Gastroduodenal Anastomosis
• Interventions: Procedure: deployment of through the scope covered metallic stent at the stricture site; Device: Covered Self-expandable Metallic Stents

• Registration Number: NCT02193789
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anastomosis site stricture	deployment of through the scope covered metallic stent at the stricture site	anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis
Anastomosis site stricture	Covered Self-expandable Metallic Stents	anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis

Primary Outcome Measures

Name	Time	Method
Improvement of symptom (Resolving anastomosis site stricture)	Up to 1 month	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.

Secondary Outcome Measures

Name	Time	Method
Complications associated with the procedure	Up to 1 month (time of stent removal)	Check all the complications associated with the procedure (e.g. procedure failure, stent migration, no improvement of symptom, etc.)

Trial Locations

Locations (2)

Ajou university hospital; 🇰🇷 Suwon, Gyeong-gi do, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of