A RCT of Low MBO Drainage Strategies

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:

A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06196164
• Other study ID #: K3807
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Peking Union Medical College Hospital
• Contact: Xi WU, M.D.
• Phone: 13683296860
• Email: wxpumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Jaundice
• Jaundice, Obstructive

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stent patency time	The interval between the operation day and the occurrence of cholangitis and biliary obstruction	0-24months