A RCT of Low MBO Drainage Strategies

NCT ID: NCT06196164

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2026-08-31

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EUS-BD

Endoscopic Ultrasound-guided Biliary Drainage

Group Type: EXPERIMENTAL

EUS-BD

Intervention Type: PROCEDURE

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-BD

Endoscopic Retrograde Cholangiopancreatography

Group Type: OTHER

ERCP-BD

Intervention Type: PROCEDURE

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.

Interventions

EUS-BD

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.

Intervention Type: PROCEDURE

ERCP-BD

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age:18 years old or above;

2. Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;

3. Distal malignant bile duct obstruction (2cm away from the hepatic hilum);

4. Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;

5. The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.

Exclusion Criteria

1. Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;

2. Uncorrectable coagulation abnormalities or bleeding tendencies (INR>1.5 or platelets<50) × 109 /L);

3. 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;

4. Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;

5. Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;

6. Pregnancy, lactation, or planned pregnancy;

7. Refusal to join or inability to provide informed consent;

8. Other researchers evaluated the unsuitability of enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wu Xi

associate professor，M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xi WU

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

K3807

Identifier Type: -

Identifier Source: org_study_id