Clinical trial NCT02460432: Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
Official title: A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Neoplasms
Biliary Obstruction
Pancreatic Neoplasms
Keywords: Drug-eluting Biliary stent
Covered metalic stent
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.

Detailed description: In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 19 years of age
* Malignant mid or distal biliary obstruction
* Unresectable cancer
* Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
* Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

* Patients who had undergone surgical biliary drainage
* Severe bleeding disorder (e.g. coagulopathy)
* Polypoid lesion or intra-abdominal abscess
* Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Primary outcomes:
measure: Cumulative stent patency during 6months after stent placement
timeFrame: 6 month
Secondary outcomes:
measure: Stent migration
timeFrame: 6 month
measure: Secondary stent insertion due to recurrent biliary obstruction
timeFrame: 6 month
measure: Mean survival
timeFrame: 6 month
measure: Adverse events
timeFrame: 6 month
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
state: Bokji-ro Busanjin-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Haehak-ro Jongno-gu
city: Incheon
country: Korea, Republic of
facility: In Ha University Hospital
state: Inhang-ro Jung-gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-Dong, Gangnam-Gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Dong Ki Lee, Ph.D MD
role: STUDY_CHAIR
affiliation: Samsung Medical Center
name: Kyu Taek Lee, Ph.D MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Sang Hyub Lee, Ph.D MD
role: PRINCIPAL_INVESTIGATOR
affiliation: In Ha University Hospital
name: Don Haeng Lee, Ph.D MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jung Sik Choi, Ph.D MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9.