Malignant Biliary ObstructionNCT01869894
A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction
A study testing metallic biliary stent insertion (double bare - S&G Biotech.), metallic biliary stent insertion (single bare - S&G Biotech.) and metallic biliary stent insertion (single bare - Taewoong Medical.) in people with Malignant Biliary Obstruction, run by Yonsei University at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- metallic biliary stent insertion (double bare - S&G Biotech.), metallic biliary stent insertion (single bare - S&G Biotech.) and metallic biliary stent insertion (single bare - Taewoong Medical.)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who had malignant biliary obstruction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul, 120-752
About this study
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
- Conditions
- Malignant Biliary Obstruction
- Being tested
- metallic biliary stent insertion (double bare - S&G Biotech.), metallic biliary stent insertion (single bare - S&G Biotech.), metallic biliary stent insertion (single bare - Taewoong Medical.)
- Keywords
- Malignant biliary obstruction, metal stent, patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metallic biliary stent insertion (double bare - S&G Biotech.)Procedure or surgery
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 or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| uncovered double bare metallic stent (S&G Biotech.) | Active comparator | uncovered double bare metallic stent Receives: 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 Receives: Procedure: metallic biliary stent insertion (single bare - S&G Biotech.) |
| uncovered single bare metallic stent (Taewoong Medical.) | Active comparator | uncovered single bare metallic stent Receives: Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median patency duration
Primary end point : A. Median patency duration
Measured: Approximately 6 months later since the date of stent insertion
Secondary outcomes (1)
6-months patency rate
Secondary end point : A. 6-months patency rate
Measured: Approximately 6 months later since the date of stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869894
- Sponsor's protocol ID
- 4-2013-0204
- Status last verified
- Sep 2015
- First submitted
- 29 May 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
Publications
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.
PubMed 15082593Davids 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.
PubMed 1281903Lee 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.
PubMed 27864713
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT01869894
- Acronym / sponsor ID
- 4-2013-0204
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Malignant biliary obstruction, metal stent, patency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uncovered double bare metallic stent (S&G Biotech.) | Active comparator | Procedure: metallic biliary stent insertion (double bare - S&G Biotech.)uncovered double bare metallic stent |
| uncovered single bare metallic stent (S&G Biotech.) | Active comparator | Procedure: metallic biliary stent insertion (single bare - S&G Biotech.)uncovered single bare metallic stent |
| uncovered single bare metallic stent (Taewoong Medical.) | Active comparator | Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)uncovered single bare metallic stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who had malignant biliary obstruction
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | uncovered double bare metallic stent (S&G Biotech.) |
| 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. | Procedure or surgery | uncovered single bare metallic stent (S&G Biotech.) |
| 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. | Procedure or surgery | uncovered single bare metallic stent (Taewoong Medical.) |
Primary outcome
Median patency duration
Time frame: Approximately 6 months later since the date of stent insertion
Primary end point : A. Median patency duration
1 secondary outcome
6-months patency rate
Time frame: Approximately 6 months later since the date of stent insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Results publication: PubMed 15082593Isayama 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.
- Results publication: PubMed 1281903Davids 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.
- Derived from this study: PubMed 27864713Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metallic biliary stent insertion (double bare - S&G Biotech.), metallic biliary stent insertion (single bare - S&G Biotech.) and metallic biliary stent insertion (single bare - Taewoong Medical.) in people with Malignant Biliary Obstruction, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median patency duration (time frame: Approximately 6 months later since the date of stent insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869894, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.