Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent

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

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

Study Overview

• Status: Recruiting
• Conditions: Bile Duct Diseases; Hilar Cholangiocarcinoma; Klatskin Tumor; Biliary Disease; Biliary Stricture; Bile Duct Stenosis; Cholangiocarcinoma, Hilar
• Intervention / Treatment: Device: Endoscopic nasobiliary duct cutting; Device: Bilateral plastic stent

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 Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianfeng Yang, Doctor; Phone Number: (+86)13454132186; Email: yjf-1976@163.com, yjf3303@zju.edu.cn
• Study Contact Backup: Name: Wangyang Chen; Phone Number: (+86)18868108329; Email: 22118301@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Hangzhou First People's Hospital
      • Contact: Jianfeng Yang, Doctor; Phone Number: (+86)13454132186; Email: yjf-1976@163.com, yjf3303@zju.edu.cn
      • Contact: Wangyang Chen; Phone Number: (+86)18868108329; Email: 22118301@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Investigators: Principal Investigator: Jianfeng Yang, Doctor, First People's Hospital of Hangzhou

Publications and helpful links

General Publications

• 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 complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9.
• 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 cholangiocarcinoma. J Gastroenterol. 2011 Feb;46(2):242-8. doi: 10.1007/s00535-010-0298-1. Epub 2010 Aug 11.
• 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 Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial. J Clin Med. 2021 Jan 8;10(2):206. doi: 10.3390/jcm10020206.
• 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 Malignant Hilar Biliary Obstruction: A Multicenter Retrospective Study. Digestion. 2022;103(3):205-216. doi: 10.1159/000521510. Epub 2022 Jan 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stent; Endoscopic Retrograde Cholangiopancreatography; Endoscopic Drainage; Nasobiliary Duct
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Biliary Tract Diseases; Constriction, Pathologic; Cholangiocarcinoma; Klatskin Tumor; Bile Duct Diseases; Gallbladder Diseases
• Other Study ID Numbers: 2023-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No