Jaundice, ObstructiveNCT06196164
A RCT of Low MBO Drainage Strategies
A study testing EUS-BD and ERCP-BD in people with Jaundice, Obstructive and Cholangiopancreatography, Endoscopic Retrograde, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaundice, Obstructive, Cholangiopancreatography, Endoscopic Retrograde, Endoscopic Ultrasound-Guided Drainage
- What is being tested?
- EUS-BD and ERCP-BD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to Aug 2026
- 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 old or above;
- Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;
- Distal malignant bile duct obstruction (2cm away from the hepatic hilum);
- Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;
- The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.
Who cannot join
- Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
- Uncorrectable coagulation abnormalities or bleeding tendencies (INR>1.5 or platelets<50) × 109 /L);
- There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months;
- Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
- Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
- Pregnancy, lactation, or planned pregnancy;
- Refusal to join or inability to provide informed consent;
- Other researchers evaluated the unsuitability of enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies
The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.
- Conditions
- Jaundice, Obstructive, Cholangiopancreatography, Endoscopic Retrograde, Endoscopic Ultrasound-Guided Drainage
- Being tested
- EUS-BD, ERCP-BD
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-BDProcedure or surgery
We observe the bile duct through endoscopic ultrasound, then puncture through the gastric or duodenum wall and place a guide wire, expanding along the guide wire, finally place a stent between the bile duct and the stomach or intestine for drainage.
ERCP-BDProcedure or surgery
We use a Duodenoscopy to pass through mouth down to the small opening where the bile duct and pancreatic drain. A small narrow catheter is passed through the scope to gain access to the drainage duct , followed by advancement of a wire deep into the duct. A small cut is made at the bile duct opening to help facilitate a stent placed in the bile duct.
| Study group | Role | What they receive |
|---|---|---|
| EUS-BD | Experimental | Endoscopic Ultrasound-guided Biliary Drainage Receives: Procedure: EUS-BD |
| ERCP-BD | Other | Endoscopic Retrograde Cholangiopancreatography Receives: Procedure: ERCP-BD |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent patency time
The interval between the operation day and the occurrence of cholangitis and biliary obstruction
Measured: 0-24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start25 Jan 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, ObstructiveStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Xi, Peking Union Medical College Hospital
- Investigators
- Xi WU, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196164
- Sponsor's protocol ID
- K3807
- Status last verified
- Sep 2025
- First submitted
- 24 Dec 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies
- ClinicalTrials.gov ID
- NCT06196164
- Acronym / sponsor ID
- K3807
- Conditions
- Jaundice, Obstructive, Cholangiopancreatography, Endoscopic Retrograde, Endoscopic Ultrasound-Guided Drainage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Jan 2024 (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.
The purpose of this study is to evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-BD | Experimental | Procedure: EUS-BDEndoscopic Ultrasound-guided Biliary Drainage |
| ERCP-BD | Other | Procedure: ERCP-BDEndoscopic Retrograde Cholangiopancreatography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age:18 years old or above;
- Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;
- Distal malignant bile duct obstruction (2cm away from the hepatic hilum);
- Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;
- The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.
Key exclusion criteria (8 listed)
- Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
- Uncorrectable coagulation abnormalities or bleeding tendencies (INR>1.5 or platelets<50) × 109 /L);
- There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months;
- Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
- Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
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 |
|---|---|---|
| EUS-BDWe observe the bile duct through endoscopic ultrasound, then puncture through the gastric or duodenum wall and place a guide wire, expanding along the guide wire, finally place a stent between the bile duct and the stomach or intestine for drainage. | Procedure or surgery | EUS-BD |
| ERCP-BDWe use a Duodenoscopy to pass through mouth down to the small opening where the bile duct and pancreatic drain. A small narrow catheter is passed through the scope to gain access to the drainage duct , followed by advancement of a wire deep into the duct. A small cut is made at the bile duct opening to help facilitate a stent placed in the bile duct. | Procedure or surgery | ERCP-BD |
Primary outcome
stent patency time
Time frame: 0-24months
The interval between the operation day and the occurrence of cholangitis and biliary obstruction
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 5 Sep 2025.
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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.
Xi WU study director
Peking Union Medical College 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 EUS-BD and ERCP-BD in people with Jaundice, Obstructive and Cholangiopancreatography, Endoscopic Retrograde, run by Peking Union Medical College 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 5 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. 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?
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?
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?
stent patency time (time frame: 0-24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2025.