NCT03353181

Brief Summary

The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

November 21, 2017

Last Update Submit

August 22, 2022

Conditions

Endoscopic Retrograde CholangiopancreatographyKlatskin Tumor

Keywords

Endoscopic Retrograde Cholangiopancreatographyendoscopic drainageendoscopic nasobiliary drainagestent

Outcome Measures

Primary Outcomes (1)

  • occurrence of acute cholangitis

    Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).

    30 days

Secondary Outcomes (2)

  • Clinical success

    30 days

  • Re-intervention

    6 months

Other Outcomes (1)

  • early adverse

    30 days

Study Arms (2)

Endoscopic scissors

EXPERIMENTAL

Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed.

Device: Endoscopic scissors

Stent

ACTIVE COMPARATOR

Standard placement of biliary stent for malignant hilar biliary strictures.

Device: Biliary stent

Interventions

Endoscopic scissorsDEVICE

Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.

Endoscopic scissors
Biliary stentDEVICE

Standard placement of biliary stent

Stent

Eligibility Criteria

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

You may qualify if:

  • Patients age over 18 and able to tolerate ERCP.
  • Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV.
  • No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage.
  • No acute cholangitis before ERCP.
  • Informed consent.

You may not qualify if:

  • The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment.
  • Previous biliary drainage procedure.
  • Inability to provide informed consent.
  • Participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

  • Uchida N, Ezaki T, Fukuma H, Tsutsui K, Kobara H, Bang MH, Ogawa M, Watanabe K, Ono M, Morishita A, Ogi T, Kamata H, Masaki T, Watanabe S, Kuriyama S. Conversion of endoscopic nasobiliary drainage to internal drainage by means of endoscopic scissor forceps. Endoscopy. 2002 Feb;34(2):180. doi: 10.1055/s-2002-19841. No abstract available.

    PMID: 11822021BACKGROUND

  • 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: 22895398BACKGROUND

  • Asanuma Y, Andoh H, Tanaka J, Koyama K. [Biliary tract cancer]. Nihon Rinsho. 2001 Nov;59 Suppl 7:301-6. No abstract available. Japanese.

    PMID: 11808135BACKGROUND

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Zhaoshen Li, M.D

    Changhai Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 27, 2017

Study Start

November 30, 2017

Primary Completion

September 25, 2019

Study Completion

December 25, 2019

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)