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

Primary Purpose

Bile Duct Obstruction, Klatskin's Tumor

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SEMS insertion
DLS insertion
Sponsored by
Soon Chun Hyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Obstruction focused on measuring Malignant hilar stricture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Soon Chun Hyang University Cheonan HospitalRecruiting
  • Inje University Pusan Paik HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Eulji University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SEMS

DLS

Arm Description

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

DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.

Outcomes

Primary Outcome Measures

Stent patency
Interval time (d) from stent insertion to occlusion

Secondary Outcome Measures

All cause complications
Early or Late complications asymptomatic hyperamylasemia pancreatitis (mild/moderate/severe) cholecystitis cholangitis recurrent jaundice Internal migration external migration occlusion
Cost-effectiveness
Total Cost for SEMS and DLS group ERCP cost Total ERBD cost (DLS or metal) Total hospitalization cost Cost for session x No. of session Total (DLS vs. metal)cost /session
Mortality
Technical success
Successful insertion of bilateral or unilateral stent insertion. Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs No stent migration within 24 hrs

Full Information

First Posted
May 14, 2010
Last Updated
March 9, 2011
Sponsor
Soon Chun Hyang University
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1. Study Identification

Unique Protocol Identification Number
NCT01125865
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Soon Chun Hyang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Obstruction, Klatskin's Tumor
Keywords
Malignant hilar stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEMS
Arm Type
Active Comparator
Arm Description
Self-expandable metallic stent will be inserted for the malignant hilar obstruction.
Arm Title
DLS
Arm Type
Active Comparator
Arm Description
DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.
Intervention Type
Device
Intervention Name(s)
SEMS insertion
Other Intervention Name(s)
Bona stent, TaeWoong stent
Intervention Description
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
Intervention Type
Device
Intervention Name(s)
DLS insertion
Other Intervention Name(s)
Olympus DoubleLayer stent
Intervention Description
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
Primary Outcome Measure Information:
Title
Stent patency
Description
Interval time (d) from stent insertion to occlusion
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
All cause complications
Description
Early or Late complications asymptomatic hyperamylasemia pancreatitis (mild/moderate/severe) cholecystitis cholangitis recurrent jaundice Internal migration external migration occlusion
Time Frame
Up to 2 years
Title
Cost-effectiveness
Description
Total Cost for SEMS and DLS group ERCP cost Total ERBD cost (DLS or metal) Total hospitalization cost Cost for session x No. of session Total (DLS vs. metal)cost /session
Time Frame
Up to 2 years
Title
Mortality
Time Frame
Up to 2 years
Title
Technical success
Description
Successful insertion of bilateral or unilateral stent insertion. Time to adequate expansion (70% of maximal expanded diameter was dilated state) in metal stent ≤ 24 hrs No stent migration within 24 hrs
Time Frame
within 24 hr after stent insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do Hyun Park, MD
Phone
+82-2-3010-3180
Email
dhpark@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Hoon Lee, MD
Phone
+82-41-570-3662
Email
thlee9@lycos.co.kr
Facility Information:
Facility Name
Soon Chun Hyang University Cheonan Hospital
City
Cheonan
State/Province
23-20 Bongmyung-dong
ZIP/Postal Code
330-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Hoon Lee, MD
Phone
+82-41-570-3662
Email
thlee9@lycos.co.kr
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
State/Province
Busanjin-gu, Gaegeum-dong
ZIP/Postal Code
614-735
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Sik Choi, MD
Phone
+82-51-890-6114
Email
cwj1225@medigate.net
Facility Name
Asan Medical Center
City
Seoul
State/Province
Pungnap-2dong, Songpagu
ZIP/Postal Code
388-1
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD
Phone
+82-2-3010-3180
Email
dhpark@amc.seoul.kr
Facility Name
Eulji University Hospital
City
Daejeon
State/Province
Seo-gu, Dunsan-dong
ZIP/Postal Code
302-799
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Woo Cha, MD
Phone
+82-42-611-3052
Email
swcha@eulji.ac.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
14648409
Citation
Tringali A, Mutignani M, Perri V, Zuccala G, Cipolletta L, Bianco MA, Rotondano G, Philipper M, Schumacher B, Neuhaus H, Schmit A, Deviere J, Costamagna G. A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures. Endoscopy. 2003 Dec;35(12):992-7. doi: 10.1055/s-2003-44601.
Results Reference
background
PubMed Identifier
7686100
Citation
Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8. doi: 10.1055/s-2007-1010295.
Results Reference
background
PubMed Identifier
10536130
Citation
de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999 Oct 28;341(18):1368-78. doi: 10.1056/NEJM199910283411807. No abstract available.
Results Reference
background
PubMed Identifier
10202060
Citation
Yeoh KG, Zimmerman MJ, Cunningham JT, Cotton PB. Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis. Gastrointest Endosc. 1999 Apr;49(4 Pt 1):466-71. doi: 10.1016/s0016-5107(99)70044-1.
Results Reference
background
PubMed Identifier
9609426
Citation
Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest Endosc. 1998 May;47(5):354-62. doi: 10.1016/s0016-5107(98)70218-4.
Results Reference
background
PubMed Identifier
1281903
Citation
Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. doi: 10.1016/0140-6736(92)92752-2.
Results Reference
background
PubMed Identifier
9468416
Citation
Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, Choury AD, Buffet C. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998 Jan;47(1):1-7. doi: 10.1016/s0016-5107(98)70291-3.
Results Reference
background
PubMed Identifier
12085032
Citation
Cheng JL, Bruno MJ, Bergman JJ, Rauws EA, Tytgat GN, Huibregtse K. Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents. Gastrointest Endosc. 2002 Jul;56(1):33-9. doi: 10.1067/mge.2002.125364.
Results Reference
background

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

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