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

Malignant Biliary Obstruction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869894
• Other study ID #: 4-2013-0204
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: September 29, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. — View Citation

Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant bil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median patency duration	Primary end point : A. Median patency duration	Approximately 6 months later since the date of stent insertion	No
Secondary	6-months patency rate	Secondary end point : A. 6-months patency rate	Approximately 6 months later since the date of stent insertion	No