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

Ajou University School of Medicine

Status: Completed

Conditions: Gastroduodenal Anastomosis

Treatments: Procedure: deployment of through the scope covered metallic stent at the stricture site; Device: Covered Self-expandable Metallic Stents

Study type: Interventional

Funder types: Other

Identifiers

NCT02193789

AJIRB-MED-MDB-14-059

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

Anastomosis site stricture

Experimental group

Description:

anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis

Treatment:

Device: Covered Self-expandable Metallic Stents

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