Above or across? trial tests which stent placement keeps bile flowing longer
NCT ID NCT07811791
First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
Cancer near the liver's bile duct junction can block bile flow, causing jaundice and infection. Doctors usually drain the bile with a plastic stent placed through an endoscope. This trial randomly assigns about 70 adults with inoperable high-grade hilar biliary obstruction to one of two stent positions: entirely inside the bile duct above the opening, or across the opening into the intestine. Researchers track how long each stent keeps bile flowing before it blocks again, along with survival and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- plastic biliary stent placement during an endoscopic procedure (ERCP), either above or across the bile duct opening
- What this could lead to
- If one placement method keeps bile flowing longer, doctors could use it to delay repeat procedures and reduce hospital visits for people with inoperable bile duct cancer.
- What could go wrong
- Earlier studies comparing these methods gave mixed results, so the difference may be small or absent. Stents can still block or shift, and this trial enrolls only about 70 people with a specific type of blockage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Feb 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Biliary drainage are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
8 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Chung Shan Medical University Hospital
Taichung, Taiwan
-
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
-
National Cheng Kung University Hospital
Tainan, Taiwan
-
National Taiwan University Cancer Center
Taipei, Taiwan
-
National Taiwan University Hospital (Coordinating Center)
Taipei, Taiwan
-
National Taiwan University Hospital Hsinchu Branch, Biomedical Park Hospital
Hsinchu, Taiwan
-
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
-
Tri-Service General Hospital
Taipei, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which drainage technique works best when cancer blocks the bile duct?
- Can Long-Term tucatinib use remain safe for HER2-Positive cancers?
- Ultrasound inside the body reveals how tumors block the bile duct
- Newer scope technique may outperform standard procedure for Cancer-Related bile duct blockage
- Draining the bile duct: does it improve daily life for cancer patients?
- Immunotherapy-Chemo cocktail shows promise for Hard-to-Treat bile duct cancer