Clinical trial NCT06106750: Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent
Official title: The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholangiocarcinoma, Hilar
Biliary Stricture
Hilar Cholangiocarcinoma
Klatskin Tumor
Biliary Disease
Bile Duct Diseases
Bile Duct Stenosis
Keywords: Endoscopic Retrograde Cholangiopancreatography
Nasobiliary Duct
Stent
Endoscopic Drainage
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The occurrence of cholangitis
timeFrame: 1 month
measure: Clinical success
timeFrame: 1 month
Secondary outcomes:
measure: Re-intervention
timeFrame: 6 month
measure: Adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Jianfeng Yang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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 complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9.
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 cholangiocarcinoma. J Gastroenterol. 2011 Feb;46(2):242-8. doi: 10.1007/s00535-010-0298-1. Epub 2010 Aug 11.
citation: 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.
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 Malignant Hilar Biliary Obstruction: A Multicenter Retrospective Study. Digestion. 2022;103(3):205-216. doi: 10.1159/000521510. Epub 2022 Jan 26.