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Completed

NCT Number: NCT00945516

Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture

The purpose of this study is to determine the feasibility, easy removability, safety, and migration rate of flared end fully covered self-expanding metal stent (FCSEMS) and anchoring FCSEMS for benign biliary stricture.

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Key information

Conditions

Bile Duct Disease Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

Benign biliary strictures (BBS) are usually managed with plastic stents, whereas placement of uncovered metallic stents has been associated with failure related to mucosal hyperplasia. Fully covered self-expanding metal stent(FCSEMS) placement was reported as a useful method for BBS. However, stent migration was a frequent complication of CSEMS placement. Recently, flared end FCSEMS was developed to decrease stent migration, and anchoring CSEMS was newly developed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient over 18 years old
  • Patient with benign bile duct stricture

Exclusion criteria

  • No written informed consent
  • Malignant biliary obstruction
  • Patients with uncorrectable severe coagulopathy
  • Patients with severe cardiopulmonary disease precluding sedation

Treatment and study plan

Bona stent® (Flared end FCSEMS)

Device

Flared end FCSEMS for benign bile duct stricture will be inserted with ERCP.

Other names: Bona stent® (Sewoon medical Co., LTD., Seoul, Korea)

Hanarostent® (Anchoring FCSEMS)

Device

Anchoring FCSEMS for benign bile duct stricture will be inserted with ERCP.

Other names: Hanarostent® (M.I.Tech, Seoul, Korea)

Primary outcomes

  1. Stent migration rate

    Time frame: one year

Secondary outcomes

  1. Feasibility (Technical success rate and functional success rate)

    Time frame: one year

  2. Safety (Procedure related early complications occurred within one month and late complications occurred one month after the procedure)

    Time frame: one year

  3. Removability

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Newly Designed Fully Covered Metal Stent for the Benign Biliary Stricture: Prospective Randomized Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 24, 2009
Registry last updated
Oct 19, 2010

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.

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