NCT06106750

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

Cholangiocarcinoma, HilarBiliary StrictureHilar CholangiocarcinomaKlatskin TumorBiliary DiseaseBile Duct DiseasesBile Duct Stenosis

Keywords

Endoscopic Retrograde CholangiopancreatographyNasobiliary DuctStentEndoscopic Drainage

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Re-intervention

    6 month

  • Adverse events

    1 month

Study Arms (2)

Nasobiliary duct cutting

EXPERIMENTAL

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

Bilateral plastic stent

ACTIVE COMPARATOR

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

Device: Bilateral plastic stent

Interventions

Endoscopic nasobiliary duct cuttingDEVICE

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.

Nasobiliary duct cutting
Bilateral plastic stentDEVICE

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

Bilateral plastic stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22895398RESULT

  • 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.

    PMID: 20700608RESULT

  • 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.

    PMID: 33430020RESULT

  • 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.

    PMID: 35081535RESULT

MeSH Terms

Conditions

Klatskin TumorGallbladder DiseasesBile Duct Diseases

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Jianfeng Yang, Doctor

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianfeng Yang, Doctor

CONTACT

(+86)13454132186yjf-1976@163.com, yjf3303@zju.edu.cn

Wangyang Chen

CONTACT

(+86)1886810832922118301@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department director

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)