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Completed

NCT Number: NCT02193789

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou university hospital, Suwon, Gyeong-gi Do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Covered Self-expandable Metallic Stents

Device

Primary outcomes

  1. Improvement of symptom (Resolving anastomosis site stricture)

    Time frame: 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 outcomes

  1. Complications associated with the procedure

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2014
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.