NCT01869894

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

May 29, 2013

Last Update Submit

September 29, 2015

Conditions

Malignant Biliary Obstruction

Keywords

Malignant biliary obstructionmetal stentpatency

Outcome Measures

Primary Outcomes (1)

  • Median patency duration

    Primary end point : A. Median patency duration

    Approximately 6 months later since the date of stent insertion

Secondary Outcomes (1)

  • 6-months patency rate

    Approximately 6 months later since the date of stent insertion

Study Arms (3)

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

ACTIVE COMPARATOR

uncovered double bare metallic stent

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

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

ACTIVE COMPARATOR

uncovered single bare metallic stent

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

uncovered single bare metallic stent (Taewoong Medical.)

ACTIVE COMPARATOR

uncovered single bare metallic stent

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

Interventions

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.

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

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

uncovered single bare metallic stent (Taewoong Medical.)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients who had malignant biliary obstruction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Related Publications (3)

  • 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 biliary obstruction. Gut. 2004 May;53(5):729-34. doi: 10.1136/gut.2003.018945.

    PMID: 15082593RESULT

  • 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. doi: 10.1016/0140-6736(92)92752-2.

    PMID: 1281903RESULT

  • Lee HJ, Chung MJ, Park JY, Park SW, Nam CM, Song SY, Bang S. A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction. Surg Endosc. 2017 Aug;31(8):3159-3167. doi: 10.1007/s00464-016-5341-8. Epub 2016 Nov 18.

    PMID: 27864713DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 5, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

KR(1)