Application of Endoscopic Scissors Cutting ENBD Tube in the Treatment of Malignant Hilar Biliary Strictures

NCT ID: NCT03353181

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-12-25

Brief Summary

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

Detailed Description

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The management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.The application of stent (plastic or metallic) has allowed us to achieve successful drainage. However,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. The application of endoscopic cutting technique is considered to reduce these complication.

Conditions

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Endoscopic Retrograde Cholangiopancreatography Klatskin Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic scissors

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

Group Type EXPERIMENTAL

Endoscopic scissors

Intervention Type DEVICE

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

Stent

Standard placement of biliary stent for malignant hilar biliary strictures.

Group Type ACTIVE_COMPARATOR

Biliary stent

Intervention Type DEVICE

Standard placement of biliary stent

Interventions

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Endoscopic scissors

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

Intervention Type DEVICE

Biliary stent

Standard placement of biliary stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Fuzhou General Hospital

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role collaborator

Chengdu PLA General Hospital

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

General Hospital of Beijing PLA Military Region

OTHER

Sponsor Role collaborator

Dongfang Hospital Beijing University of Chinese Medicine

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

ShuGuang Hospital

OTHER

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Department of Gastroenterology, Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 11822021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22895398 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11808135 (View on PubMed)

Other Identifiers

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ENBD-01

Identifier Type: -

Identifier Source: org_study_id

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