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AzTrials

Bile Duct ObstructionPhase 4NCT01125865

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

A Phase 4 study testing SEMS insertion and DLS insertion in people with Bile Duct Obstruction and Klatskin's Tumor, run by Soon Chun Hyang University at 4 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bile Duct Obstruction, Klatskin's Tumor
What is being tested?
SEMS insertion and DLS insertion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesSouth Korea
Study dates
May 2010to Dec 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient over 18 years old
  • Patient with malignant hilar obstruction

Who cannot join

  • No written informed consent
  • Patient with uncorrectable severe coagulopathy
  • Indication for surgical operation
  • Karnofsky score < 60%

Trial locations and contacts

4 sites in 1 country.

Do Hyun Park, MD contact

+82-2-3010-3180

dhpark@amc.seoul.kr

Tae Hoon Lee, MD contact

+82-41-570-3662

thlee9@lycos.co.kr

South Korea4 sites, 4 recruiting

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan, 23-20 Bongmyung-dong, 330-721

    Tae Hoon Lee, MD, +82-41-570-3662, thlee9@lycos.co.kr

    Recruiting

  • Eulji University Hospital

    Daejeon, Seo-gu, Dunsan-dong, 302-799

    Sang Woo Cha, MD, +82-42-611-3052, swcha@eulji.ac.kr

    Recruiting

  • Inje University Pusan Paik Hospital

    Pusan, Busanjin-gu, Gaegeum-dong, 614-735

    Jung Sik Choi, MD, +82-51-890-6114, cwj1225@medigate.net

    Recruiting

  • Asan Medical Center

    Seoul, Pungnap-2dong, Songpagu, 388-1

    Do Hyun Park, MD, +82-2-3010-3180, dhpark@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

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

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.

Being tested
SEMS insertion, DLS insertion
Keywords
Malignant hilar stricture
Medical subject headings
Cholestasis, Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEMS insertionDevice

    Also called Bona stent, TaeWoong stent

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

  • DLS insertionDevice

    Also called Olympus DoubleLayer stent

    DoubleLayer plastic stent will be inserted for malignant hilar obstruction.

Study groups in NCT01125865
Study groupRoleWhat they receive
SEMSActive comparatorSelf-expandable metallic stent will be inserted for the malignant hilar obstruction.
Receives: Device: SEMS insertion
DLSActive comparatorDoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.
Receives: Device: DLS insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stent patency

    Interval time (d) from stent insertion to occlusion

    Measured: Up to 2 years

Secondary outcomes (4)

  1. All cause complications

    Early or Late complications

    • asymptomatic hyperamylasemia
    • pancreatitis (mild/moderate/severe)
    • cholecystitis
    • cholangitis
    • recurrent jaundice
    • Internal migration
    • external migration
    • occlusion

    Measured: Up to 2 years

  2. 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

    Measured: Up to 2 years

  3. Mortality

    Measured: Up to 2 years

  4. 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

    Measured: within 24 hr after stent insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionJul 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01125865
Sponsor's protocol ID
SCH-2010-04
Status last verified
May 2010
First submitted
14 May 2010
Last updated
10 Mar 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14648409

  • 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.

    PubMed 7686100

  • 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.

    PubMed 10536130

  • 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.

    PubMed 10202060

  • 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.

    PubMed 9609426

  • 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.

    PubMed 1281903

  • 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.

    PubMed 9468416

  • 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.

    PubMed 12085032

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SEMS insertion and DLS insertion in people with Bile Duct Obstruction and Klatskin's Tumor, run by Soon Chun Hyang University at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Do Hyun Park, MD (+82-2-3010-3180, dhpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stent patency (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01125865, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2011.

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