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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEMS | Experimental | self-expandable metal stent group |
|
| PS | Active Comparator | plastic stent group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biliary stent (self expandable metallic stent) | Device | metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 2 weeks and 4 weeks after stent insertion |
| 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. | at 2 weeks and 4 weeks after stent insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Survival Times | survival times of the patients after the first stent insertion | until patient died or 6 months after the last patient was enrolled |
| Cost Effective Ratio of Metallic and Plastic Stent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| apichat sangchan, MD | Department of Medicine. Faculty of Medicine. KhonKaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Srinagarind Hospital. KhonKaen University. | Muang | KhonKaen | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12838220 | Background | De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3. doi: 10.1067/mge.2003.310. | |
| 7686100 | Background | 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. |
| Label | URL |
|---|---|
| KhonKaen University Ethics Committee for Human Research | View source |
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the patients were excluded from trial after enrollment if CBD canulation is failed.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | SEMS | self-expandable metal stent group |
| FG001 | Plastic Stent | plastic stent group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SEMS | self-expandable metal stent group |
| BG001 | Plastic Stent | plastic stent group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group) | Posted | Mean | 95% Confidence Interval | proportion of participants | at 2 weeks and 4 weeks after stent insertion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEMS | self-expandable metal stent group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholangitis | Hepatobiliary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sphicterotomy bleeding | Hepatobiliary disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assist. Prof. Apichat Sangchan | Khon Kaen University | 66850004651 | apichaz@yahoo.com |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D000069322 | Self Expandable Metallic Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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|
| PS | Device | plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP |
|
|
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
| until the patients expire (Markov model) |
| 12838219 | Background | Freeman ML, Overby C. Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents. Gastrointest Endosc. 2003 Jul;58(1):41-9. doi: 10.1067/mge.2003.292. |
| 22595446 | Derived | Sangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial. Gastrointest Endosc. 2012 Jul;76(1):93-9. doi: 10.1016/j.gie.2012.02.048. Epub 2012 May 15. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Patients Survival Times | survival times of the patients after the first stent insertion | Posted | Median | Inter-Quartile Range | days | until patient died or 6 months after the last patient was enrolled |
|
|
|
|
| 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 | 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 | Posted | Number | cost (US$) per QALY | until the patients expire (Markov model) |
|
|
|
| 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. | 91 participants who had successful stent insertion were analyzed based on per protocol analysis. | Posted | Mean | 95% Confidence Interval | proportion of participants | at 2 weeks and 4 weeks after stent insertion |
|
|
|
|
| 14 |
| 54 |
| 0 |
| 54 |
| EG001 | Plastic Stent | plastic stent group | 21 | 54 | 1 | 54 |
| pancreatitis | Hepatobiliary disorders |
|
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| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |