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Endoscopic Retrograde CholangiopancreatographyENBDNCT03353181

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

A study testing Endoscopic scissors and Biliary stent in people with Endoscopic Retrograde Cholangiopancreatography and Klatskin Tumor, run by Changhai Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Endoscopic scissors and Biliary stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
30 Nov 2017to 25 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Gastroenterology, Changhai Hospital, Second Military Medical University

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Application of Endoscopic Scissors Cutting Endoscopic Nasobiliary Drainage Tube in the Treatment of Malignant Hilar Biliary Strictures: a Multicenter, Prospective, Randomized Controlled Study

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

Read the detailed description

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.

Being tested
Endoscopic scissors, Biliary stent
Keywords
Endoscopic Retrograde Cholangiopancreatography, endoscopic drainage, endoscopic nasobiliary drainage, stent
Medical subject headings
Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic scissorsDevice

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

  • Biliary stentDevice

    Standard placement of biliary stent

Study groups in NCT03353181
Study groupRoleWhat they receive
Endoscopic scissorsExperimentalEndoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed.
Receives: Device: Endoscopic scissors
StentActive comparatorStandard placement of biliary stent for malignant hilar biliary strictures.
Receives: Device: Biliary stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurrence of acute cholangitis

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

    Measured: 30 days

Secondary outcomes (2)

  1. Clinical success

    Clinical success was defined as a decrease in the total bilirubin level to ≤50% of the pretreatment value within 1 week or to ≤75% within 4 weeks.

    Measured: 30 days

  2. Re-intervention

    Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start30 Nov 2017
  3. Primary completion25 Sep 2019
  4. Study completion25 Dec 2019

Why it stopped: Failure to recruit patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353181
Sponsor's protocol ID
ENBD-01
Acronym
ENBD
Status last verified
Aug 2022
First submitted
21 Nov 2017
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11822021

  • 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.

    PubMed 22895398

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

    PubMed 11808135

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic scissors and Biliary stent in people with Endoscopic Retrograde Cholangiopancreatography and Klatskin Tumor, run by Changhai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence of acute cholangitis (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353181, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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