Clinical trial NCT02166970: Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction
Official title: Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Klatskin Tumor
Keywords: Hilar tumor
Metal stent
Single
Multiple
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

First as an unilateral or bilateral stent will be deployed according to criteria.

In bilateral group, stent-in-stent or side-by-side deployment will be included.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* inoperable hilar malignancy

Exclusion Criteria:

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

Primary outcomes:
measure: Reintervention rate when stents occluded
timeFrame: 2 years
Secondary outcomes:
measure: Technical success of single or multiple stents
timeFrame: 1 month
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Tae Hoon Lee
Study officials:
affiliation: SoonChunHyang University School of Medicine
name: Tae Hoon Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.