Single Versus Multiple Deployment of Metallic Stents for Inoperable Malignant Hilar Biliary Obstruction

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Reintervention rate when stents occluded

Secondary Outcome

 Technical success of single or multiple stents

Condition

Klatskin Tumor

Intervention

Metallic stent deployment in hilar obstruction

Study Arms / Comparison Groups

 Single stent deployment
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

130

Start Date

March 1, 2014

Completion Date

October 30, 2016

Primary Completion Date

February 28, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  age > 18 years

          -  inoperable hilar malignancy

        Exclusion Criteria:

          -  age under 18 years

          -  uncontrolled coagulopathy

          -  inability to provide informed consent
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tae Hoon Lee, MD, PhD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT02166970

Organization ID

Hilar stenting


Responsible Party

Principal Investigator

Study Sponsor

Soon Chun Hyang University


Study Sponsor

Tae Hoon Lee, MD, PhD, Principal Investigator, SoonChunHyang University School of Medicine


Verification Date

February 2017