Malignant Biliary ObstructionIRCSMBONCT02001779
IRS(Irradiation Stent) vs. CS(Conventional Stent) Insertion in Inoperable Malignant Biliary Obstruction
A study testing Biliary SEMS loaded with 125I seeds and Conventional biliary SEMS in people with Malignant Biliary Obstruction, run by Zhongda Hospital at 1 site in China.
Trial summary
Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- Biliary SEMS loaded with 125I seeds and Conventional biliary SEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Sep 2016
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical,histological or pathological diagnosis of malignant biliary obstruction
- Unresectability or refusal to be surgically treated
- The Eastern Cooperative Oncology Group(ECOG) scores from 0 to 3
- With symptoms such as jaundice related to biliary obstruction
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Biliary obstruction of Bismuthe-Corlette,type I and II
Who cannot join
- Benign biliary obstruction
- The Eastern Cooperative Oncology Group(ECOG) score of 4
- Biliary tract stricture that could not be dilated enough to pass the delivery system
- Presence of metallic biliary stent or bile duct surgery
- Percutaneous transhepatic cholangiography(PTC) procedure was contraindicated
- Active hepatitis
- Biliary obstruction of Bismuthe-Corlette,type Ⅲ and Ⅳ
- Uncooperative or could not provide authorization and signature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Stent Insertion Combined With or Without Brachytherapy in Patients With Inoperable Malignant Biliary Obstruction
Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.
Read the detailed description
Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical process is usually silent and insidious,only 10-20% patients can be surgically removed once obstructive jaundice occurred.The long-term survival rate after resection remain dismal.Relief of obstructive jaundice plays major role on prognosis in patients without surgical indications.For unresectable patients,stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice.Although a number of new techniques for treatment of malignant biliary obstruction have been developed,there have been no significant differences in survival or quality of life comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic stents insertion,or covered stent versus uncovered stents insertion in such patients.Our previous unicentric clinical trial has demonstrated the safety and technical feasibility of a biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion in the overall survival and stent patency between two groups.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- Biliary SEMS loaded with 125I seeds, Conventional biliary SEMS
- Keywords
- Malignant biliary obstruction, Obstruction/stricture, Stent, Brachytherapy, Bile duct
- Medical subject headings
- Bites and Stings, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary SEMS loaded with 125I seedsDevice
A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.
Conventional biliary SEMSDevice
A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.
| Study group | Role | What they receive |
|---|---|---|
| Biliary SEMS loaded with 125I seeds | Experimental | A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction. Receives: Device: Biliary SEMS loaded with 125I seeds |
| Conventional biliary SEMS | Active comparator | A self-expandable metallic biliary stent is inserted in patients with inoperable malignant biliary obstruction. Receives: Device: Conventional biliary SEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency
Time from stenting to the day when stricture/obstruction of the stent occured or restricture/reobstruction after recanalization the obstructed stent.
Measured: Participants will be followed till die or lost to follow-up,an expected average of a year.
Secondary outcomes (3)
Over survival
Time from stenting to the day when the patients died or lost to the follow-up.
Measured: Participants will be followed till die or lost to follow-up,an expected average of a year.
Clinical success
The rate of relief of the symptoms and signs of the patients.
Measured: Participants will be followed till die or lost to follow-up,an expected average of a year.
Safety
Including technique success rate,side effect/complication,radioactive safety.
Measured: Participants will be followed till die or lost to follow-up,an expected average of a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-jun Teng, Ph.D,MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001779
- Sponsor's protocol ID
- IR-C-STENT-MBO-83272121
- Acronym
- IRCSMBO
- Status last verified
- Feb 2017
- First submitted
- 22 Nov 2013
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhu HD, Guo JH, Huang M, Ji JS, Xu H, Lu J, Li HL, Wang WH, Li YL, Ni CF, Shi HB, Xiao EH, Lv WF, Sun JH, Xu K, Han GH, Du LA, Ren WX, Li MQ, Mao AW, Xiang H, Zhang KX, Min J, Zhu GY, Su C, Chen L, Teng GJ. Irradiation stents vs. conventional metal stents for unresectable malignant biliary obstruction: A multicenter trial. J Hepatol. 2018 May;68(5):970-977. doi: 10.1016/j.jhep.2017.12.028. Epub 2018 Jan 10.
PubMed 29331343
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Stent Insertion Combined With or Without Brachytherapy in Patients With Inoperable Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT02001779
- Acronym / sponsor ID
- IRCSMBO / IR-C-STENT-MBO-83272121
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Malignant biliary obstruction, Obstruction/stricture, Stent, Brachytherapy, Bile duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Dec 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.
Stenting the malignant biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice in patients without surgical indications of malignant biliary obstruction.An unicentral clinical trial has demonstrated the safety and technical feasibility of an irradiation biliary stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.
Detailed description
Malignant biliary obstruction is a common condition caused by various carcinomas.The clinical process is usually silent and insidious,only 10-20% patients can be surgically removed once obstructive jaundice occurred.The long-term survival rate after resection remain dismal.Relief of obstructive jaundice plays major role on prognosis in patients without surgical indications.For unresectable patients,stenting the biliary obstruction is considered to be the preferred palliation modality to relieve pruritus,cholangitis,pain and jaundice.Although a number of new techniques for treatment of malignant biliary obstruction have been developed,there have been no significant differences in survival or quality of life comparing surgery bypass versus plastic stent insertion,metal stent insertion versus plastic stents insertion,or covered stent versus uncovered stents insertion in such patients.Our previous unicentric clinical trial has demonstrated the safety and technical feasibility of a biliary intraluminal irradiation stent insertion in patients with biliary obstruction caused by adenocarcinomas, such a treatment seems have benefits in relieving jaundice and extending survival when compared to a conventional biliary stent.However,the small sample size,the population distribution of two groups will influence the final results in obtaining a powerful statistical conclusion in the overall survival and stent patency between two groups.Therefore,a multicentric study was designed to prospectively compared the responses to the treatment with this irradiation biliary stent versus the conventional biliary self-expandable stent in patients with inoperable malignant biliary obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliary SEMS loaded with 125I seeds | Experimental | Device: Biliary SEMS loaded with 125I seedsA self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction. |
| Conventional biliary SEMS | Active comparator | Device: Conventional biliary SEMSA self-expandable metallic biliary stent is inserted in patients with inoperable malignant biliary obstruction. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical,histological or pathological diagnosis of malignant biliary obstruction
- Unresectability or refusal to be surgically treated
- The Eastern Cooperative Oncology Group(ECOG) scores from 0 to 3
- With symptoms such as jaundice related to biliary obstruction
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Key exclusion criteria (8 listed)
- Benign biliary obstruction
- The Eastern Cooperative Oncology Group(ECOG) score of 4
- Biliary tract stricture that could not be dilated enough to pass the delivery system
- Presence of metallic biliary stent or bile duct surgery
- Percutaneous transhepatic cholangiography(PTC) procedure was contraindicated
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 |
|---|---|---|
| Biliary SEMS loaded with 125I seedsA self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction. | Device | Biliary SEMS loaded with 125I seeds |
| Conventional biliary SEMSA self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction. | Device | Conventional biliary SEMS |
Primary outcome
Patency
Time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.
Time from stenting to the day when stricture/obstruction of the stent occured or restricture/reobstruction after recanalization the obstructed stent.
3 secondary outcomes
Over survival
Time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.
Clinical success
Time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.
Safety
Time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.
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 14 Feb 2017.
- Derived from this study: PubMed 29331343Zhu HD, Guo JH, Huang M, Ji JS, Xu H, Lu J, Li HL, Wang WH, Li YL, Ni CF, Shi HB, Xiao EH, Lv WF, Sun JH, Xu K, Han GH, Du LA, Ren WX, Li MQ, Mao AW, Xiang H, Zhang KX, Min J, Zhu GY, Su C, Chen L, Teng GJ. Irradiation stents vs. conventional metal stents for unresectable malignant biliary obstruction: A multicenter trial. J Hepatol. 2018 May;68(5):970-977. doi: 10.1016/j.jhep.2017.12.028. Epub 2018 Jan 10.
- Individual participant dataSharing planned: No
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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.
Gao-jun Teng, Ph.D,MD principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biliary SEMS loaded with 125I seeds and Conventional biliary SEMS in people with Malignant Biliary Obstruction, run by Zhongda Hospital at 1 site in China.
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 6 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 14 Feb 2017. 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 China. 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?
Patency (time frame: Participants will be followed till die or lost to follow-up,an expected average of a year.). 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 NCT02001779, which also lists 1 linked publication.
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 14 Feb 2017.