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Cancer of Bile DuctPhase 4NCT01041612

Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

A Phase 4 study testing PTFE Covered ComVi [full covered] Biliary Stent in people with Cancer of Bile Duct and Pancreatic Cancer, run by Taewoong Medical Co., Ltd. at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Bile Duct, Pancreatic Cancer
What is being tested?
PTFE Covered ComVi [full covered] Biliary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
13 sitesin 2 countries
Study dates
Jan 2010to Sep 2012
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

  • Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old
  • Bile duct or gallbladder cancer invading CBD or distal CHD
  • Pancreatic cancer with mid or distal CBD invasion
  • Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
  • First attempt of endoscopic biliary metallic stenting
  • Negative history of biliary tract surgery
  • Life expectancy at least longer than 4 months (Karnofsky score >60%)

Who cannot join

  • Ampullary cancer
  • Klatskin tumor
  • Combined intrahepatic bile duct cancer
  • Patient with hemobilia
  • Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Japan7 sites

  • Gifu University

    Gifu

  • Onomichi General Hospital

    Onomichi

  • Teine-Keijinkai Hospital

    Sapporo

  • The University of Tokyo

    Tokyo

  • Toho University

    Tokyo

  • Tokyo Medical University

    Tokyo

  • Yamaguchi University

    Ube

Other trials in Japan

South Korea6 sites

  • Soon Chun Hyang University School of Medicine

    Bucheon-si

  • Soon Chun Hyang University School of Medicine

    Cheonan

  • Catholic University of Daegu School of Medicine

    Daegu

  • Inha University School of Medicine

    Incheon

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Ajou University School of Medicine

    Suwon

Other trials in South Korea

About this study

Official title: Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Being tested
PTFE Covered ComVi [full covered] Biliary Stent
Keywords
CBD, HBD, cancer of bile duct, pancreatic cancer
Medical subject headings
Bile Duct Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • PTFE Covered ComVi [full covered] Biliary StentDevice

    Also called PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea

    The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.

  • PTFE Covered ComVi [full covered] Biliary StentDevice

    Also called PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea

    The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.

Study groups in NCT01041612
Study groupRoleWhat they receive
Group A: C-SEMS, inserted above SOActive comparator-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
Receives: Device: PTFE Covered ComVi [full covered] Biliary Stent
Group B: C-SEMS, inserted across SOActive comparator-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
Receives: Device: PTFE Covered ComVi [full covered] Biliary Stent

What is being measured

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

  1. Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange

    Measured: one year

Secondary outcomes (1)

  1. Death of patients

    Measured: one year

Timeline

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

  1. First posted1 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

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
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041612
Sponsor's protocol ID
RaMM-BO 2.0
Status last verified
Oct 2016
First submitted
28 Dec 2009
Last updated
21 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Jung Nam Cho, Jimin Han, Ho Gak Kim, IM Hee Shin, Sang Heum Park, Jong Ho Moon, Jin Hong Kim, Don Haeng Lee, Iruru Maetani, Hiroyuki Maguchi, Keiji Hanada, Ichiro Yasuda, Takao Itoi, Hiroyuki Isayama, Dongki Lee. Prospective Randomized Trial Comparing Covered Metal Stent Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction. Gastrointestinal Endoscopy 77(58): AB139-AB140, 2013

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PTFE Covered ComVi [full covered] Biliary Stent in people with Cancer of Bile Duct and Pancreatic Cancer, run by Taewoong Medical Co., Ltd. at 13 sites in 2 countries.

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 7 inclusion and 5 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: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange (time frame: one year). 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 NCT01041612, which also lists 1 linked publication.

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 21 Oct 2016.

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