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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Malignant Biliary Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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uncovered double bare metallic stent (S&G Biotech.)

uncovered double bare metallic stent

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

uncovered single bare metallic stent (S&G Biotech.)

uncovered single bare metallic stent

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

uncovered single bare metallic stent (Taewoong Medical.)

uncovered single bare metallic stent

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No