Malignant Distal Biliary Stricture Clinical Trial
Official title:
A Randomized Trial of Partially Covered Versus Uncovered Self Expandable Metal Stents for the Palliation of Malignant Distal Biliary Stricture
| NCT number | NCT02178618 |
| Other study ID # | AJIRB-DEV-DE3-14-001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | June 25, 2014 |
| Last updated | June 27, 2014 |
| Verified date | June 2014 |
| Source | Ajou University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been
used as a principle palliative method of distal biliary obstruction in patients with
pancreaticobiliary cancers. With potentially curative surgical resection being impossible,
the maintenance of successful biliary drainage through patent stent has been regarded as the
key to improve the quality of life and survival of patient, because it could prevent biliary
infection or liver failure, and give patients opportunities for anti-cancer chemotherapy
and/or radiotherapy.
Although SEMSs have been reported to be superior to large bore plastic stents in terms of
stent patency, they still have some controversial issues to resolve in relation to stent
dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to
overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant
higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not
show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs,
despite some clinical results of randomized trials favor to covered SEMSs.
From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting
results have been produced. It was initially assumed that covered SEMSs could cause the
higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic
duct and cystic duct by covering materials. However, no significant difference was found
with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered
SEMSs in several randomized trials and meta-analysis.
The aim of the current study is to compare the cumulative stent patency of partially covered
and uncovered SEMS as a primary objective, and investigate overall patient survival, stent
dysfunction-free patient survival, and incidence of adverse events including stent
dysfunction as secondary objectives.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | January 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: 1. > 20 years 2. malignant biliary obstruction, 2 cm distal to hilum 3. unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal 4. expected survival > 4 months based on Karnofsky performance score. Exclusion Criteria: 1. history of biliary surgery except cholecystectomy 2. history of SEMS placement 3. coagulopathy (INR>1.5, Platelet<50000) 4. duodenal stricture |
N/A
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Ajou University Hospital | Suwon | Gyeong gi do |
| Lead Sponsor | Collaborator |
|---|---|
| Ajou University School of Medicine |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cumulative stent patency | From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months | ||
| Secondary | Overall patient survival | From the date of randomization until the date of death from any cause, assessed upto 12 months | ||
| Secondary | Stent dysfunction free-patient survival | From the date of randomization until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months |