Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106750
• Other study ID #: 2023-10
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: October 2023
• Source: First People's Hospital of Hangzhou
• Contact: Jianfeng Yang, Doctor
• Phone: (+86)13454132186
• Email: yjf-1976[@]163.com, yjf3303[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Biliary Disease
• Biliary Stricture
• Cholangiocarcinoma
• Constriction, Pathologic
• Gallbladder Diseases
• Hilar Cholangiocarcinoma
• Klatskin Tumor

Intervention

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

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (4)

Hakuta R, Kogure H, Nakai Y, Kawakami H, Maguchi H, Mukai T, Iwashita T, Saito T, Togawa O, Matsubara S, Hayashi T, Maetani I, Ito Y, Hasebe O, Itoi T, Hanada K, Isayama H. Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal S — View Citation

Kawakami H, Kuwatani M, Onodera M, Haba S, Eto K, Ehira N, Yamato H, Kudo T, Tanaka E, Hirano S, Kondo S, Asaka M. Endoscopic nasobiliary drainage is the most suitable preoperative biliary drainage method in the management of patients with hilar cholangio — View Citation

Kawashima H, Itoh A, Ohno E, Itoh Y, Ebata T, Nagino M, Goto H, Hirooka Y. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to — View Citation

Sugiura R, Kuwatani M, Hayashi T, Yoshida M, Ihara H, Yamato H, Onodera M, Katanuma A; Hokkaido Interventional EUS/ERCP study (HONEST) group. Endoscopic Nasobiliary Drainage Comparable with Endoscopic Biliary Stenting as a Preoperative Drainage Method for — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of cholangitis	Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP).	1 month
Primary	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	Re-intervention	Re-intervention was defined that endoscopic or percutaneous procedure to improve biliary drainage for jaundice or cholangitis after successful placement.	6 month
Secondary	Adverse events	ERCP-related adverse events	1 month