Biliary Tract NeoplasmsNCT07811791
Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
A study testing Suprapapillary plastic stent placement and Transpapillary plastic stent placement in people with Biliary Tract Neoplasms and Biliary Drainage, run by National Taiwan University Hospital at 8 sites in Taiwan.
Trial summary
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Neoplasms, Biliary Drainage, Malignant Biliary Obstruction
- What is being tested?
- Suprapapillary plastic stent placement and Transpapillary plastic stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 8 sitesTaiwan
- Study dates
- 1 Sep 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Unresectable high-grade malignant hilar biliary obstruction (Bismuth type II, III, or IV) diagnosed by CT, MRI, and/or previous surgical specimen
- Need for biliary drainage due to biliary obstruction (serum total bilirubin ≥2 mg/dL or diagnosis of cholangitis)
- Life expectancy greater than 3 months
- No stent previously placed in the biliary system
- Written informed consent for participation in the study
Who cannot join
- Condition not allowing endoscopic intervention
- Failed biliary cannulation
- Surgically altered anatomy of the upper gastrointestinal tract, excluding Billroth-I reconstruction
- Previous endoscopic or surgical ampullectomy, papilloplasty, or surgical bilioenteric anastomosis
- Previous placement of external biliary drainage (e.g., percutaneous transhepatic biliary drainage)
- Primary sclerosing cholangitis, immunoglobulin G4-associated cholangitis, or primary biliary cholangitis
- Pregnancy
- Patients who opt for self-paid metal stent placement and are judged suitable for metal stents by the treating physician
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Taiwan8 sites
National Taiwan University Hospital Hsinchu Branch, Biomedical Park Hospital
Hsinchu
Sheng Jie Chang, +886-972653951, shawnchang0524@ntuh.gov.tw
Taipei Tzu Chi Hospital
New Taipei City
Chung Shan Medical University Hospital
Taichung
Sheng Jie Chang, +886-972653951, shawnchang0524@ntuh.gov.tw
National Cheng Kung University Hospital
Tainan
National Taiwan University Cancer Center
Taipei
ShengJie Chang, MD, +886-972653951, shawnchang0524@ntuh.gov.tw
National Taiwan University Hospital (Coordinating Center)
Taipei
Yu-Ting Kuo, MD, +886-972652398, sfstruck@gmail.com
Tri-Service General Hospital
Taipei
Sheng Jie Chang, +886-972653951, shawnchang0524@ntuh.gov.tw
Linkou Chang Gung Memorial Hospital
Taoyuan
Sheng Jie Chang, +886-972653951, shawnchang0524@ntuh.gov.tw
About this study
Official title: Suprapapillary Versus Transpapillary Biliary Plastic Stents for Unresectable High-grade Malignant Hilar Biliary Obstruction
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results.
This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.
Read the detailed description
Malignant hilar biliary obstruction (MHBO) is among the most challenging conditions in therapeutic biliary endoscopy. Uncovered self-expandable metal stents provide longer patency but cannot be removed, which complicates reintervention as oncologic therapy prolongs survival. Plastic stents remain a removable, reversible option, though with shorter patency. The suprapapillary (inside) plastic stent concept, proposed in 1998, aims to prolong stent patency and reduce ascending bacterial infection by preserving the sphincter of Oddi, but existing evidence is limited to small trials and retrospective series with inconsistent results, and no adequately powered randomized trial has addressed high-grade hilar obstruction.
This is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial conducted at eight institutions in Taiwan. Patients with unresectable Bismuth type II or higher MHBO are randomized 1:1 to suprapapillary or transpapillary plastic stent placement. Randomization is performed after successful biliary cannulation during ERCP, using a centralized web-based system (REDCap) with stratification by site. The primary endpoint is time to recurrent biliary obstruction (TRBO). Secondary endpoints include overall survival, technical and clinical success, reintervention rate, and adverse events. Participants are followed until recurrent biliary obstruction, death, or the end of the study period.
- Conditions
- Biliary Tract Neoplasms, Biliary Drainage, Malignant Biliary Obstruction, Obstructive Jaundice
- Being tested
- Suprapapillary plastic stent placement, Transpapillary plastic stent placement
- Keywords
- suprapapillary stent, inside stent, transpapillary stent, plastic biliary stent, ERCP, endoscopic biliary drainage, stent patency, time to recurrent biliary obstruction, Bismuth classification
- Medical subject headings
- Biliary Tract Neoplasms, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprapapillary plastic stent placementProcedure or surgery
Also called iPS
Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent). The distal end of the stent remains within the
Transpapillary plastic stent placementProcedure or surgery
Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen. Commercially available, regulatory-approved plastic biliary stents are used; stent size and number are determined by the endoscopist according to the stricture anatomy.
| Study group | Role | What they receive |
|---|---|---|
| Suprapapillary plastic stent (iPS) | Experimental | Endoscopic placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent), with the distal end positioned within the bile duct and the sphincter of Oddi preserved, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction. Receives: Procedure: Suprapapillary plastic stent placement |
| Transpapillary plastic stent (tPS) | Active comparator | Endoscopic placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction. Receives: Procedure: Transpapillary plastic stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrent biliary obstruction (TRBO)
Time from stent placement to recurrent biliary obstruction (RBO), defined as stent occlusion or symptomatic stent migration requiring biliary reintervention. Participants without RBO are censored at death, elective stent removal or exchange, or last follow-up. Estimated by the Kaplan-Meier method.
Measured: From stent placement until RBO, death, or end of follow-up, assessed up to 12 months
Secondary outcomes (4)
Overall survival
Time from stent placement to death from any cause. Participants alive at last follow-up are censored.
Measured: From stent placement until death or end of follow-up, assessed up to 12 months
Technical success rate
Proportion of participants with successful stent placement across or above the stricture in the intended position, confirmed by cholangiography.
Measured: During the index ERCP procedure (Day 0)
Clinical success rate
Proportion of participants with adequate biliary drainage after stent placement, defined as a decrease in serum total bilirubin to less than 50% of the pre-procedure value or below a prespecified threshold.
Measured: Within 14 days after stent placement
Incidence of procedure- and stent-related adverse events
Adverse events including post-ERCP pancreatitis, cholangitis, cholecystitis, bleeding, perforation, and stent migration, graded according to the ASGE lexicon severity grading system.
Measured: ：From stent placement until end of follow-up, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Model description
- Participants are randomized 1:1 to suprapapillary or transpapillary plastic stent placement after successful biliary cannulation during ERCP.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Ting Kuo, Medical doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811791
- Sponsor's protocol ID
- 202604033RINB
- Status last verified
- Jul 2026
- First submitted
- 30 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, in accordance with the informed consent obtained and institutional data protection regulations. Data are stored on the institutional REDCap server of National Taiwan University Hospital and are not permitted to be transferred outside the hospital network. Aggregate results will be published in peer-reviewed journal.
Publications
Angsuwatcharakon P, Kulpatcharapong S, Chuncharunee A, Khor C, Devereaux B, Moon JH, Ratanachu-Ek T, Wang HP, Pausawasdi N, Maydeo A, Itoi T, Ponnudurai R, Ramchandani M, Nakai Y, Seo DW, Ogura T, Tang RS, Kongkam P, Makmun D, Dy F, Ridtitid W, Kuo YT, Pham KC, Oung B, Lee J, Rerknimitr R. The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction. Endosc Int Open. 2024 Sep 16;12(9):E1065-E1074. doi: 10.1055/a-2366-7302. eCollection 2024 Sep.
PubMed 39285860Kovacs N, Pecsi D, Sipos Z, Farkas N, Foldi M, Hegyi P, Bajor J, Eross B, Marta K, Miko A, Rakonczay Z Jr, Sarlos P, Abraham S, Vincze A. Suprapapillary Biliary Stents Have Longer Patency Times than Transpapillary Stents-A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 23;12(3):898. doi: 10.3390/jcm12030898.
PubMed 36769545Kanno Y, Ito K, Nakahara K, Kawaguchi S, Masaki Y, Okuzono T, Kato H, Kuwatani M, Ishii S, Murabayashi T, Hasegawa S, Nagahama M, Iwashita Y, Michikawa Y, Terada S, Kawakami Y, Fujii Y, Kawakubo K. Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial. Gastrointest Endosc. 2023 Aug;98(2):211-221.e3. doi: 10.1016/j.gie.2023.03.007. Epub 2023 Mar 11.
PubMed 36907528Kurita A, Uza N, Asada M, Yoshimura K, Takemura T, Yazumi S, Kodama Y, Seno H. Stent placement above the sphincter of Oddi is a useful option for patients with inoperable malignant hilar biliary obstruction. Surg Endosc. 2022 May;36(5):2869-2878. doi: 10.1007/s00464-021-08576-x. Epub 2021 Jun 2.
PubMed 34076770Pedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0.
PubMed 9852446
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprapapillary Versus Transpapillary Biliary Plastic Stents for Unresectable High-grade Malignant Hilar Biliary Obstruction
- ClinicalTrials.gov ID
- NCT07811791
- Acronym / sponsor ID
- 202604033RINB
- Conditions
- Biliary Tract Neoplasms, Biliary Drainage, Malignant Biliary Obstruction, Obstructive Jaundice
- Keywords
- suprapapillary stent, inside stent, transpapillary stent, plastic biliary stent, ERCP, endoscopic biliary drainage, stent patency, time to recurrent biliary obstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 10 Sep 2026 (actual)
- 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.
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results.
This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.
Detailed description
Malignant hilar biliary obstruction (MHBO) is among the most challenging conditions in therapeutic biliary endoscopy. Uncovered self-expandable metal stents provide longer patency but cannot be removed, which complicates reintervention as oncologic therapy prolongs survival. Plastic stents remain a removable, reversible option, though with shorter patency. The suprapapillary (inside) plastic stent concept, proposed in 1998, aims to prolong stent patency and reduce ascending bacterial infection by preserving the sphincter of Oddi, but existing evidence is limited to small trials and retrospective series with inconsistent results, and no adequately powered randomized trial has addressed high-grade hilar obstruction.
This is an investigator-initiated, multicenter, open-label, parallel-group randomized controlled trial conducted at eight institutions in Taiwan. Patients with unresectable Bismuth type II or higher MHBO are randomized 1:1 to suprapapillary or transpapillary plastic stent placement. Randomization is performed after successful biliary cannulation during ERCP, using a centralized web-based system (REDCap) with stratification by site. The primary endpoint is time to recurrent biliary obstruction (TRBO). Secondary endpoints include overall survival, technical and clinical success, reintervention rate, and adverse events. Participants are followed until recurrent biliary obstruction, death, or the end of the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to suprapapillary or transpapillary plastic stent placement after successful biliary cannulation during ERCP.
| Arm | Type | Receives |
|---|---|---|
| Suprapapillary plastic stent (iPS) | Experimental | Procedure: Suprapapillary plastic stent placementEndoscopic placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent), with the distal end positioned within the bile duct and the sphincter of Oddi preserved, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction. |
| Transpapillary plastic stent (tPS) | Active comparator | Procedure: Transpapillary plastic stent placementEndoscopic placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen, performed during ERCP after successful biliary cannulation for unresectable high-grade malignant hilar biliary obstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Unresectable high-grade malignant hilar biliary obstruction (Bismuth type II, III, or IV) diagnosed by CT, MRI, and/or previous surgical specimen
- Need for biliary drainage due to biliary obstruction (serum total bilirubin ≥2 mg/dL or diagnosis of cholangitis)
- Life expectancy greater than 3 months
- No stent previously placed in the biliary system
Key exclusion criteria (8 listed)
- Condition not allowing endoscopic intervention
- Failed biliary cannulation
- Surgically altered anatomy of the upper gastrointestinal tract, excluding Billroth-I reconstruction
- Previous endoscopic or surgical ampullectomy, papilloplasty, or surgical bilioenteric anastomosis
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 |
|---|---|---|
| Suprapapillary plastic stent placementAlso: iPSEndoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent). The distal end of the stent remains within the | Procedure or surgery | Suprapapillary plastic stent (iPS) |
| Transpapillary plastic stent placementEndoscopic retrograde cholangiopancreatography (ERCP) with placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen. Commercially available, regulatory-approved plastic biliary stents are used; stent size and number are determined by the endoscopist according to the stricture anatomy. | Procedure or surgery | Transpapillary plastic stent (tPS) |
Primary outcome
Time to recurrent biliary obstruction (TRBO)
Time frame: From stent placement until RBO, death, or end of follow-up, assessed up to 12 months
Time from stent placement to recurrent biliary obstruction (RBO), defined as stent occlusion or symptomatic stent migration requiring biliary reintervention. Participants without RBO are censored at death, elective stent removal or exchange, or last follow-up. Estimated by the Kaplan-Meier method.
4 secondary outcomes
Overall survival
Time frame: From stent placement until death or end of follow-up, assessed up to 12 months
Technical success rate
Time frame: During the index ERCP procedure (Day 0)
Clinical success rate
Time frame: Within 14 days after stent placement
Incidence of procedure- and stent-related adverse events
Time frame: ：From stent placement until end of follow-up, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 39285860Angsuwatcharakon P, Kulpatcharapong S, Chuncharunee A, Khor C, Devereaux B, Moon JH, Ratanachu-Ek T, Wang HP, Pausawasdi N, Maydeo A, Itoi T, Ponnudurai R, Ramchandani M, Nakai Y, Seo DW, Ogura T, Tang RS, Kongkam P, Makmun D, Dy F, Ridtitid W, Kuo YT, Pham KC, Oung B, Lee J, Rerknimitr R. The updated Asia-Pacific consensus statement on the role of endoscopic management in malignant hilar biliary obstruction. Endosc Int Open. 2024 Sep 16;12(9):E1065-E1074. doi: 10.1055/a-2366-7302. eCollection 2024 Sep.
- Background: PubMed 36769545Kovacs N, Pecsi D, Sipos Z, Farkas N, Foldi M, Hegyi P, Bajor J, Eross B, Marta K, Miko A, Rakonczay Z Jr, Sarlos P, Abraham S, Vincze A. Suprapapillary Biliary Stents Have Longer Patency Times than Transpapillary Stents-A Systematic Review and Meta-Analysis. J Clin Med. 2023 Jan 23;12(3):898. doi: 10.3390/jcm12030898.
- Background: PubMed 36907528Kanno Y, Ito K, Nakahara K, Kawaguchi S, Masaki Y, Okuzono T, Kato H, Kuwatani M, Ishii S, Murabayashi T, Hasegawa S, Nagahama M, Iwashita Y, Michikawa Y, Terada S, Kawakami Y, Fujii Y, Kawakubo K. Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial. Gastrointest Endosc. 2023 Aug;98(2):211-221.e3. doi: 10.1016/j.gie.2023.03.007. Epub 2023 Mar 11.
- Background: PubMed 34076770Kurita A, Uza N, Asada M, Yoshimura K, Takemura T, Yazumi S, Kodama Y, Seno H. Stent placement above the sphincter of Oddi is a useful option for patients with inoperable malignant hilar biliary obstruction. Surg Endosc. 2022 May;36(5):2869-2878. doi: 10.1007/s00464-021-08576-x. Epub 2021 Jun 2.
- Results publication: PubMed 9852446Pedersen FM, Lassen AT, Schaffalitzky de Muckadell OB. Randomized trial of stent placed above and across the sphincter of Oddi in malignant bile duct obstruction. Gastrointest Endosc. 1998 Dec;48(6):574-9. doi: 10.1016/s0016-5107(98)70038-0.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, in accordance with the informed consent obtained and institutional data protection regulations. Data are stored on the institutional REDCap server of National Taiwan University Hospital and are not permitted to be transferred outside the hospital network. Aggregate results will be published in peer-reviewed journal.
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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.
Yu-Ting Kuo, Medical doctor principal investigator
National Taiwan University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprapapillary plastic stent placement and Transpapillary plastic stent placement in people with Biliary Tract Neoplasms and Biliary Drainage, run by National Taiwan University Hospital at 8 sites in Taiwan.
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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Jie Chang, Medical doctor (+886-972653951, shawnchang0524@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrent biliary obstruction (TRBO) (time frame: From stent placement until RBO, death, or end of follow-up, assessed up to 12 months). 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 NCT07811791, which also lists 5 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 10 Sep 2026.