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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02193789

Enrollment

Registered

2014-07-18

Start date

2014-06-30

Completion date

2015-06-30

Last updated

2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroduodenal Anastomosis

Keywords

Anastomosis site structure, Stent insertion, Stent migration

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.

Interventions

PROCEDUREdeployment 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

DEVICECovered Self-expandable Metallic Stents

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026