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OpenTrials
Completed

NCT Number: NCT01869894

A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction

Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction

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Key information

Conditions

Malignant Biliary Obstruction

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patients who had malignant biliary obstruction

Exclusion criteria

  • The patients who had resectable biliary malignancy
  • The patients who had hilar obstruction
  • The patients who had duodenal obstruction
  • The patients who had other malignancy which is not related to biliary obstruction
  • The patients who had uncontrolled infection
  • The patients who had poor performance (ECOG =3 or 4)
  • The patients who were not acquired informed consent
  • The patients who had technically difficult structure for ERCP

Treatment and study plan

metallic biliary stent insertion (double bare - S&G Biotech.)

Procedure

The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.

metallic biliary stent insertion (single bare - S&G Biotech.)

Procedure

The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.

metallic biliary stent insertion (single bare - Taewoong Medical.)

Procedure

The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.

Primary outcomes

  1. Median patency duration

    Time frame: Approximately 6 months later since the date of stent insertion

    Primary end point : A. Median patency duration

Secondary outcomes

  1. 6-months patency rate

    Time frame: Approximately 6 months later since the date of stent insertion

    Secondary end point : A. 6-months patency rate

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2013
Registry last updated
Oct 1, 2015

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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