CholangiocarcinomaNCT02659852
A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
A study testing side by side and stent in stent in people with Cholangiocarcinoma and Gallbladder Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer
- What is being tested?
- side by side and stent in stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Jan 2020
- 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
- Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
- older than 20 years old
Who cannot join
- Operable case
- Non-hilar biliary malignant obstruction
- Duodenal obstruction
- Other cancer except biliary malignancy
- uncontrolled infection status
- Eastern Cooperative Oncology Group ≥ 3
- No signed informed consent
- Failed endoscopic approach to duodenum or biliary tract
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University
Seoul, 120-752
Seungmin Bang, MD, 02-2228-5412, Bang7028@yuhs.ac
Moonjae Chung, MD, 82-10-5058-6865, mjchung@yuhs.ac
About this study
Official title: A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.
The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, HCC, AOV Cancer
- Being tested
- side by side, stent in stent
- Keywords
- Hilar malignant biliary obstruction, bilateral metal stent, stent in stent, side by side
- Medical subject headings
- Cholangiocarcinoma, Gallbladder Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
side by sideProcedure or surgery
Stenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously.
stent in stentProcedure or surgery
After first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration.
| Study group | Role | What they receive |
|---|---|---|
| Side by side group | Experimental | Not described Receives: Procedure: side by side |
| Stent in stent group | Active comparator | Not described Receives: Procedure: stent in stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median patency duration
Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent
Measured: 1 year after stent insertion
Secondary outcomes (2)
Overall survival
Measured: 1 year
complication rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659852
- Sponsor's protocol ID
- 4-2015-1072
- Status last verified
- Jan 2019
- First submitted
- 12 Jan 2016
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Law R, Baron TH. Bilateral metal stents for hilar biliary obstruction using a 6Fr delivery system: outcomes following bilateral and side-by-side stent deployment. Dig Dis Sci. 2013 Sep;58(9):2667-72. doi: 10.1007/s10620-013-2671-4. Epub 2013 Apr 27.
PubMed 23625287Kim KM, Lee KH, Chung YH, Shin JU, Lee JK, Lee KT, Shim SG. A comparison of bilateral stenting methods for malignant hilar biliary obstruction. Hepatogastroenterology. 2012 Mar-Apr;59(114):341-6. doi: 10.5754/hge11533.
PubMed 22353496
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
- ClinicalTrials.gov ID
- NCT02659852
- Acronym / sponsor ID
- 4-2015-1072
- Conditions
- Cholangiocarcinoma, Gallbladder Cancer, Pancreatic Cancer, HCC, AOV Cancer
- Keywords
- Hilar malignant biliary obstruction, bilateral metal stent, stent in stent, side by side
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Jan 2016 (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.
Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.
The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar 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 |
|---|---|---|
| Side by side group | Experimental | Procedure: side by side |
| Stent in stent group | Active comparator | Procedure: stent in stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
- older than 20 years old
Key exclusion criteria (8 listed)
- Operable case
- Non-hilar biliary malignant obstruction
- Duodenal obstruction
- Other cancer except biliary malignancy
- uncontrolled infection status
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 |
|---|---|---|
| side by sideStenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously. | Procedure or surgery | Side by side group |
| stent in stentAfter first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration. | Procedure or surgery | Stent in stent group |
Primary outcome
Median patency duration
Time frame: 1 year after stent insertion
Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent
2 secondary outcomes
Overall survival
Time frame: 1 year
complication rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Background: PubMed 23625287Law R, Baron TH. Bilateral metal stents for hilar biliary obstruction using a 6Fr delivery system: outcomes following bilateral and side-by-side stent deployment. Dig Dis Sci. 2013 Sep;58(9):2667-72. doi: 10.1007/s10620-013-2671-4. Epub 2013 Apr 27.
- Background: PubMed 22353496Kim KM, Lee KH, Chung YH, Shin JU, Lee JK, Lee KT, Shim SG. A comparison of bilateral stenting methods for malignant hilar biliary obstruction. Hepatogastroenterology. 2012 Mar-Apr;59(114):341-6. doi: 10.5754/hge11533.
- Individual participant dataSharing planned: No
Related trials for Cholangiocarcinoma
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
BOLD-100 in Combination With FOLFOX With or Without Bevacizumab for the Treatment of Advanced, Solid Tumours
Colorectal Cancer, Pancreatic Cancer
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Ovarian Neoplasms, Breast Neoplasms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing side by side and stent in stent in people with Cholangiocarcinoma and Gallbladder Cancer, 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 2 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median patency duration (time frame: 1 year after 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 NCT02659852, which also lists 2 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 28 Jan 2019.