Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Recruiting

CT.gov ID

NCT06106750

Collaborator

(none)

122

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma, Hilar Biliary Stricture Hilar Cholangiocarcinoma Klatskin Tumor Biliary Disease Bile Duct Diseases Bile Duct Stenosis	Device: Endoscopic nasobiliary duct cutting Device: Bilateral plastic stent	N/A

Detailed Description

The early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. Effective palliative treatment can significantly improve their quality of life and survival time. The method of cutting nasobiliary ducts with endoscopic scissors has many advantages. Firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. Secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. The use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nasobiliary duct cutting Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then, extracting the severed nasobiliary duct and retaining the portion inside it.	Device: Endoscopic nasobiliary duct cutting Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then extracting the severed nasobiliary duct and retaining the portion inside the duct.
Active Comparator: Bilateral plastic stent Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis	Device: Bilateral plastic stent Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis

Arm

Intervention/Treatment

Experimental: Nasobiliary duct cutting

Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then, extracting the severed nasobiliary duct and retaining the portion inside it.

Device: Endoscopic nasobiliary duct cutting

Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then extracting the severed nasobiliary duct and retaining the portion inside the duct.

Active Comparator: Bilateral plastic stent

Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis

Device: Bilateral plastic stent

Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis

Outcome Measures

Primary Outcome Measures

The occurrence of cholangitis [1 month]
Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP).
Clinical success [1 month]
Clinical success was defined that the decrease in the total bilirubin level to less than 50% of the pretreatment value within 1 week or to less than 75% within 1 month.

Secondary Outcome Measures

Re-intervention [6 month]
Re-intervention was defined that endoscopic or percutaneous procedure to improve biliary drainage for jaundice or cholangitis after successful placement.
Adverse events [1 month]
ERCP-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients over 18 years old and under 80 years old who were planned to carry out ERCP for malignant hilar biliary duct stenosis
Clinically and pathologically confirmed malignant hilar biliary duct stenosis
MRCP determines Bismuth classification: II-IV type
Comply with research procedures and sign the informed consent form

Exclusion Criteria:

The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment
The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical)
The patient is currently suffering from cholangitis
The patient is participating in other clinical trials
Inability to provide informed consent