Hilar Cholangiocarcinoma
Conditions
Keywords
biliary stent, plastic stent, metallic stent, Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)
Brief summary
The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.
Detailed description
There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (\ 3-9 months). Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.
Interventions
DEVICEbiliary stent (self expandable metallic stent)
metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
DEVICEPS
plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)
Exclusion criteria
* Patients with ASA 4 or 5 * Patients with liver failure. * Patients unable to comply with follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) | at 2 weeks and 4 weeks after stent insertion | Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient. |
| Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) | at 2 weeks and 4 weeks after stent insertion | Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients Survival Times | until patient died or 6 months after the last patient was enrolled | survival times of the patients after the first stent insertion |
| Cost Effective Ratio of Metallic and Plastic Stent | until the patients expire (Markov model) | cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature |
Countries
Thailand
Participant flow
Recruitment details
Between November 2007 and March 2010, one hundred and eight patients who visited medical clinic at Srinagarind hospital, Khon Kaen University were randomized into the study
Pre-assignment details
the patients were excluded from trial after enrollment if CBD canulation is failed.
Participants by arm
| Arm | Count |
|---|---|
| SEMS self-expandable metal stent group | 54 |
| Plastic Stent plastic stent group | 54 |
| Total | 108 |
Baseline characteristics
| Characteristic | Plastic Stent | SEMS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 98 Participants |
| Age Continuous | 57.3 years STANDARD_DEVIATION 11.7 | 62.7 years STANDARD_DEVIATION 10.3 | 60.0 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment Thailand | 54 participants | 54 participants | 108 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 43 Participants | 43 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 1 / 54 |
| serious Total, serious adverse events | 14 / 54 | 21 / 54 |
Outcome results
Primary
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)
Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.
Time frame: at 2 weeks and 4 weeks after stent insertion
Population: All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SEMS | Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) | .7037037 proportion of participants |
| Plastic Stent | Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis) | .46296 proportion of participants |
p-value: 0.01195% CI: [-0.4210726, -0.0604089]Two-sample test of proportion
Primary
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)
Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.
Time frame: at 2 weeks and 4 weeks after stent insertion
Population: 91 participants who had successful stent insertion were analyzed based on per protocol analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SEMS | Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) | 0.822 proportion of participants |
| Plastic Stent | Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis) | 0.543 proportion of participants |
p-value: 0.00495% CI: [-0.4609466, -0.0965414]Two-sample test of proportion
Secondary
Cost Effective Ratio of Metallic and Plastic Stent
cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature
Time frame: until the patients expire (Markov model)
Population: Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SEMS | Cost Effective Ratio of Metallic and Plastic Stent | 10742 cost (US$) per QALY |
| Plastic Stent | Cost Effective Ratio of Metallic and Plastic Stent | 19085 cost (US$) per QALY |
Secondary
Patients Survival Times
survival times of the patients after the first stent insertion
Time frame: until patient died or 6 months after the last patient was enrolled
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SEMS | Patients Survival Times | 126 days |
| Plastic Stent | Patients Survival Times | 49 days |
p-value: 0.0021Log Rank