NCT02649712

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

January 20, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

January 6, 2016

Last Update Submit

November 18, 2018

Conditions

CholangiocarcinomaGallbladder CarcinomaHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Overall survival

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

  • 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, assessed up to 10 months.

Study Arms (2)

Unilateral stent

ACTIVE COMPARATOR

Patients undergo placement of unilateral biliary stent on day 1.

Device: biliary stent

Bilateral stents

ACTIVE COMPARATOR

Patients undergo placement of bilateral biliary stents on day 1.

Device: biliary stent

Interventions

biliary stentDEVICE

Self-expandable biliary nitinol alloys stent

Bilateral stentsUnilateral stent

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Malignant hilar biliary obstruction;
  • Unresectable cases

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Related Publications (10)

  • 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.

    PMID: 21198916BACKGROUND

  • 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.

    PMID: 23617655BACKGROUND

  • 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.

    PMID: 22873816BACKGROUND

  • 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.

    PMID: 21940566BACKGROUND

  • 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.

    PMID: 22415652BACKGROUND

  • 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.

    PMID: 22484591BACKGROUND

  • 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.

    PMID: 14605106BACKGROUND

  • 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.

    PMID: 19220678BACKGROUND

  • 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.

    PMID: 25880978BACKGROUND

  • 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.

    PMID: 30968181DERIVED

MeSH Terms

Conditions

CholangiocarcinomaGallbladder NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesLiver NeoplasmsLiver Diseases

Study Officials

  • Chi Cao, MD

    Xuzhou Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 7, 2016

Study Start

January 20, 2016

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data available.

Locations

CN(1)