NCT02166970

Brief Summary

In Bismuth II-IV hilar cholangiocarcinoma patients with a predicted survival of longer than 3 months, metallic stent performance is superior to plastic stenting for palliation with respect to outcomes and cost-effectiveness. However, the optimal stent type and the extent of drainage are issues that remain to be definitively decided. The optimal endoscopic management strategy is contentious. The investigators conduct the present study to prospectively in multi-centers compare unilateral (single) with bilateral (multiple) deployment in inoperable malignant biliary obstructions to clarify the clinical outcomes of these two deployment methods using metallic stents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

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

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

June 13, 2014

Last Update Submit

February 27, 2017

Conditions

Klatskin Tumor

Keywords

Hilar tumorMetal stentSingleMultiple

Outcome Measures

Primary Outcomes (1)

  • Reintervention rate when stents occluded

    When the stents occluded after successful single or multiple stent deployment, the outcome measure is assessed.

    2 years

Secondary Outcomes (1)

  • Technical success of single or multiple stents

    1 month

Study Arms (2)

Single stent deployment

EXPERIMENTAL

Metallic stent deployment in hilar obstruction. Insertion of metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).

Device: Metallic stent deployment in hilar obstruction

Multiple stent deployment

ACTIVE COMPARATOR

Metallic stent deployment in hilar obstruction. Insertion of multiple metallic stent to the dominant targeted duct such as right anterior (segments V and VIII), right posterior (segments VI and VII) or left (segments II-IV).

Device: Metallic stent deployment in hilar obstruction

Interventions

Metallic stent deployment in hilar obstructionDEVICE

Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment

Also known as: Single stent insertion, Multiple stent insertion using stent-in-stent method, Multiple stent insertion using side-by-side method
Multiple stent deploymentSingle stent deployment

Eligibility Criteria

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

You may qualify if:

  • age \> 18 years
  • inoperable hilar malignancy

You may not qualify if:

  • age under 18 years
  • uncontrolled coagulopathy
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tae Hoon Lee

Cheonan, 330721, South Korea

Location

Related Publications (1)

  • Lee TH, Kim TH, Moon JH, Lee SH, Choi HJ, Hwangbo Y, Hyun JJ, Choi JH, Jeong S, Kim JH, Park DH, Han JH, Park SH. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video). Gastrointest Endosc. 2017 Nov;86(5):817-827. doi: 10.1016/j.gie.2017.04.037. Epub 2017 May 4.

    PMID: 28479493DERIVED

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Tae Hoon Lee, MD, PhD

    SoonChunHyang University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 18, 2014

Study Start

March 1, 2014

Primary Completion

February 28, 2016

Study Completion

October 30, 2016

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

KR(1)