Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

Brief Title

Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture

Official Title

Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial

Brief Summary

      The overall median survival of nonresectable malignant hilar obstruction in most series has
      been less than 6 months. Most patients with malignant hilar obstruction present with advanced
      disease, making palliative endoscopic drainage the principal therapeutic option. However, the
      optimal endoscopic management strategy is contentious. Almost all of the published data
      comparing plastic and metallic stents relate to distal tumors (those of the pancreas, common
      bile duct and ampulla). Stent patency, complication rates, and cost-effectiveness have
      favored metallic stents when compared with plastic stents in patients with distal malignant
      obstruction expected to live at least 3 to 6 months.

      There are few comparative study as to whether self-expanding metallic or plastic stent,
      especially DLS (double layer plastic stent) are preferable in the technical success, stent
      patency, and cost-effectiveness for palliating malignant hilar obstruction.

      The study was designed to compare the the technical success, stent patency, and
      cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar
      obstruction.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Stent patency

Secondary Outcome

 All cause complications

Condition

Bile Duct Obstruction

Intervention

SEMS insertion

Study Arms / Comparison Groups

 SEMS
Description:  Self-expandable metallic stent will be inserted for the malignant hilar obstruction.

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

100

Start Date

May 2010

Completion Date

December 2011

Primary Completion Date

July 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Patient over 18 years old

          -  Patient with malignant hilar obstruction

        Exclusion Criteria:

          -  No written informed consent

          -  Patient with uncorrectable severe coagulopathy

          -  Indication for surgical operation

          -  Karnofsky score < 60%
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +82-2-3010-3180, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01125865

Organization ID

SCH-2010-04



Study Sponsor

Soon Chun Hyang University


Study Sponsor

, , 


Verification Date

May 2010