Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

Zhejiang University

Status: Enrolling

Conditions: Klatskin Tumor; Bile Duct Stenosis; Bile Duct Diseases; Biliary Disease; Biliary Stricture; Hilar Cholangiocarcinoma; Cholangiocarcinoma, Hilar

Treatments: Device: Endoscopic nasobiliary duct cutting; Device: Bilateral plastic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06106750

2023-10

Details and patient eligibility

About

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

Full 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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

122 participants in 2 patient groups

Nasobiliary duct cutting

Experimental group

Description:

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.

Treatment:

Device: Endoscopic nasobiliary duct cutting

Bilateral plastic stent

Active Comparator group

Description:

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

Treatment:

Device: Bilateral plastic stent