AzTrials
AzTrials

CholangiocarcinomaNCT02649712

Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction

A study testing biliary stent in people with Cholangiocarcinoma and Gallbladder Carcinoma, run by Xuzhou Central Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
biliary stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
20 Jan 2016to 31 Oct 2018
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Malignant hilar biliary obstruction;
  • Unresectable cases

Who cannot join

  • Bismuth I patients;
  • inability to obtain informed consent;
  • Eastern Cooperative Oncology Group performance status of 4;
  • severe dysfunction in other organs.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

Other trials in China

About this study

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Read the detailed description

Malignant hilar biliary obstruction is a common clinical manifestation and it can be caused by cholangiocarcinoma, gallbladder carcinoma, liver cancer, or other metastatic carcinoma. Most patients with malignant hilar biliary obstruction are unresectable at diagnosis. Biliary stenting has been widely used in palliative treatment of malignant hilar biliary obstruction.

Hilar biliary obstruction usually involves the bifurcation of the biliary tract. Some researchers recommended unilateral stenting for malignant hilar biliary obstruction because drainage of 25% of entire liver can achieve the clinical success of biliary drainage. However, some researchers recommended bilateral stenting for malignant hilar biliary obstruction because some researches demonstrated that bilateral stenting can achieve a longer stent patency.In addition, there was no significant difference in post stenting survival between patients who were treated by unilateral or bilateral stenting. Therefore, it remains under debate whether unilateral or bilateral stenting is better in the treatment of malignant hilar biliary obstruction.

The purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with malignant hilar biliary obstruction who are treated by unilateral or bilateral stenting.

Being tested
biliary stent
Medical subject headings
Cholangiocarcinoma, Gallbladder Neoplasms, Carcinoma, Hepatocellular

What participants receive

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

  • biliary stentDevice

    Self-expandable biliary nitinol alloys stent

Study groups in NCT02649712
Study groupRoleWhat they receive
Unilateral stentActive comparatorPatients undergo placement of unilateral biliary stent on day 1.
Receives: Device: biliary stent
Bilateral stentsActive comparatorPatients undergo placement of bilateral biliary stents on day 1.
Receives: Device: biliary stent

What is being measured

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

  1. Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice)

    Stent dysfunction is suspected when the patient experiences recurrence of jaundice.

    Measured: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months

Secondary outcomes (2)

  1. Overall survival

    From the date of randomization until the date of first documented death from any cause.

    Measured: From the date of randomization until the date of first documented death from any cause, assessed up to 12 months

  2. Stent dysfunction free-patient survival

    From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first.

    Measured: From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 10 months.

Timeline

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

  1. First posted7 Jan 2016 (estimated)
  2. Study start20 Jan 2016
  3. Primary completion31 Oct 2018
  4. Study completion31 Oct 2018

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
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02649712
Sponsor's protocol ID
xzxy20160106
Status last verified
Nov 2018
First submitted
6 Jan 2016
Last updated
20 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make individual participant data available.

Publications

  • Iwano H, Ryozawa S, Ishigaki N, Taba K, Senyo M, Yoshida K, Sakaida I. Unilateral versus bilateral drainage using self-expandable metallic stent for unresectable hilar biliary obstruction. Dig Endosc. 2011 Jan;23(1):43-8. doi: 10.1111/j.1443-1661.2010.01036.x. Epub 2010 Nov 30.

    PubMed 21198916

  • Yasuda I, Mukai T, Moriwaki H. Unilateral versus bilateral endoscopic biliary stenting for malignant hilar biliary strictures. Dig Endosc. 2013 May;25 Suppl 2:81-5. doi: 10.1111/den.12060.

    PubMed 23617655

  • Liberato MJ, Canena JM. Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients. BMC Gastroenterol. 2012 Aug 9;12:103. doi: 10.1186/1471-230X-12-103.

    PubMed 22873816

  • Gwon DI, Ko GY, Sung KB, Yoon HK, Shin JH, Hyoung Kim J, Kim J, Oh JY. Percutaneous biliary metallic stent placement in patients with unilobar portal vein occlusion caused by advanced hilar malignancy: outcome of unilateral versus bilateral stenting. AJR Am J Roentgenol. 2011 Oct;197(4):795-801. doi: 10.2214/AJR.11.6424.

    PubMed 21940566

  • Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8.

    PubMed 22415652

  • Bulajic M, Panic N, Radunovic M, Scepanovic R, Perunovic R, Stevanovic P, Ille T, Zilli M, Bulajic M. Clinical outcome in patients with hilar malignant strictures type II Bismuth-Corlette treated by minimally invasive unilateral versus bilateral endoscopic biliary drainage. Hepatobiliary Pancreat Dis Int. 2012 Apr;11(2):209-14. doi: 10.1016/s1499-3872(12)60150-7.

    PubMed 22484591

  • Inal M, Akgul E, Aksungur E, Seydaoglu G. Percutaneous placement of biliary metallic stents in patients with malignant hilar obstruction: unilobar versus bilobar drainage. J Vasc Interv Radiol. 2003 Nov;14(11):1409-16. doi: 10.1097/01.rvi.0000096762.74047.a6.

    PubMed 14605106

  • Naitoh I, Ohara H, Nakazawa T, Ando T, Hayashi K, Okumura F, Okayama Y, Sano H, Kitajima Y, Hirai M, Ban T, Miyabe K, Ueno K, Yamashita H, Joh T. Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction. J Gastroenterol Hepatol. 2009 Apr;24(4):552-7. doi: 10.1111/j.1440-1746.2008.05750.x. Epub 2009 Feb 12.

    PubMed 19220678

  • Li M, Wu W, Yin Z, Han G. [Unilateral versus bilateral biliary drainage for malignant hilar obstruction: a systematic review and meta-analysis]. Zhonghua Gan Zang Bing Za Zhi. 2015 Feb;23(2):118-23. doi: 10.3760/cma.j.issn.1007-3418.2015.02.009. Chinese.

    PubMed 25880978

  • Fu YF, Zhou WJ, Shi YB, Cao W, Cao C. Percutaneous stenting for malignant hilar biliary obstruction: a randomized controlled trial of unilateral versus bilateral stenting. Abdom Radiol (NY). 2019 Aug;44(8):2900-2908. doi: 10.1007/s00261-019-02010-6.

    PubMed 30968181

Questions about this trial

What is this clinical trial studying?

A study testing biliary stent in people with Cholangiocarcinoma and Gallbladder Carcinoma, run by Xuzhou Central 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 2 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: finished, as of the sponsor's last update on 20 Nov 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Stent patency (Stent dysfunction is suspected when the patient experiences recurrence of jaundice) (time frame: From the date of randomization until the date of first documented stent dysfunction, assessed up to 10 months). 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 NCT02649712, which also lists 10 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 20 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in