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

NCT ID: NCT02193789

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-06-30

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.

Conditions

Gastroduodenal Anastomosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anastomosis site stricture

anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis

Group Type: EXPERIMENTAL

deployment of through the scope covered metallic stent at the stricture site

Intervention Type: PROCEDURE

Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site

Covered Self-expandable Metallic Stents

Intervention Type: DEVICE

Interventions

deployment of through the scope covered metallic stent at the stricture site

Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site

Intervention Type: PROCEDURE

Covered Self-expandable Metallic Stents

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kee Myung Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sun Gyo Lim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Ki Seong Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Joon Koo Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou university hospital

Suwon, Gyeong-gi Do, South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

AJIRB-MED-MDB-14-059

Identifier Type: -

Identifier Source: org_study_id