Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Endoscopic nasobiliary duct cutting
* Device: Bilateral plastic stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasobiliary duct cutting<br>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<br>* 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.<br>|
| Active Comparator: Bilateral plastic stent<br>Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis | Device: Bilateral plastic stent<br>* Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of cholangitis | Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP). | 1 month | 
| Clinical success | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intervention | Re-intervention was defined that endoscopic or percutaneous procedure to improve biliary drainage for jaundice or cholangitis after successful placement. | 6 month | 
| Adverse events | ERCP-related adverse events | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Retrograde Cholangiopancreatography, Nasobiliary Duct, Stent, Endoscopic Drainage