Biliary Cancer Clinical Trial
— SEMSOfficial title:
Covered Versus Uncovered Self-conformable Metal Stent for Palliation of Primary Malignant Extra-hepatic Biliary Strictures: a Randomized Multicenter Study
Verified date | October 2016 |
Source | Azienda USL 1 Imperiese |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
The purpose of this study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.
Status | Completed |
Enrollment | 170 |
Est. completion date | September 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Malignant obstructive disease at the level of the extrahepatic bile duct (CBD) - Serum bilirubin >50 micromol/L - Inoperability due to a poor medical condition and/or unresectable disease - = 18 years of age - Willing and able to comply with study procedures and provide written informed consent Exclusion Criteria: - Benign obstruction of the CBD - Malignancy involving intrahepatic ducts or duodenum - Prior gastric bypass or Billroth type I or type II gastric resection - Prior biliary surgery - World Health Organization (WHO) performance score of 4 (100% of time in bed) - international normalized ratio (INR)> 1.5 - Life expectancy of < 90 days |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Italy | General Hospital sanremo | Sanremo | Imperia |
Lead Sponsor | Collaborator |
---|---|
Azienda USL 1 Imperiese | NOCSAE Hospital, Modena, Italy, Ospedali Riuniti Marche Nord, Pesaro, Italy, Papa Giovanni XXIII Hospital, Bergamo, Italy, University of Siena, Italy |
Italy,
Ahmad J, Siqueira E, Martin J, Slivka A. Effectiveness of the Ultraflex Diamond stent for the palliation of malignant biliary obstruction. Endoscopy. 2002 Oct;34(10):793-6. — View Citation
Cubiella J, Castells A, Fondevila C, Sans M, Sabater L, Navarro S, Fernández-Cruz L. Prognostic factors in nonresectable pancreatic adenocarcinoma: a rationale to design therapeutic trials. Am J Gastroenterol. 1999 May;94(5):1271-8. — View Citation
Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. — View Citation
Dumonceau JM, Cremer M, Auroux J, Delhaye M, Devière J. A comparison of Ultraflex Diamond stents and Wallstents for palliation of distal malignant biliary strictures. Am J Gastroenterol. 2000 Mar;95(3):670-6. — View Citation
Ferlitsch A, Oesterreicher C, Dumonceau JM, Deviere J, Leban T, Born P, Rösch T, Suter W, Binek J, Meyenberger C, Müllner M, Schneider B, Schöfl R. Diamond stents for palliation of malignant bile duct obstruction: a prospective multicenter evaluation. Endoscopy. 2001 Aug;33(8):645-50. — View Citation
Isayama H, Kawabe T, Nakai Y, Tsujino T, Sasahira N, Yamamoto N, Arizumi T, Togawa O, Matsubara S, Ito Y, Sasaki T, Hirano K, Toda N, Komatsu Y, Tada M, Yoshida H, Omata M. Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction. Clin Gastroenterol Hepatol. 2006 Sep;4(9):1148-53. Epub 2006 Aug 14. — View Citation
Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M. A prospective randomised study of "covered" versus "uncovered" diamond stents for the management of distal malignant biliary obstruction. Gut. 2004 May;53(5):729-34. — View Citation
Kaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, Canard JM, Fritsch J, Rey JF, Burtin P. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc. 2003 Feb;57(2):178-82. — View Citation
Knyrim K, Wagner HJ, Pausch J, Vakil N. A prospective, randomized, controlled trial of metal stents for malignant obstruction of the common bile duct. Endoscopy. 1993 Mar;25(3):207-12. — View Citation
Park DH, Kim MH, Choi JS, Lee SS, Seo DW, Kim JH, Han J, Kim JC, Choi EK, Lee SK. Covered versus uncovered wallstent for malignant extrahepatic biliary obstruction: a cohort comparative analysis. Clin Gastroenterol Hepatol. 2006 Jun;4(6):790-6. Epub 2006 May 22. — View Citation
Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, Choury AD, Buffet C. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998 Jan;47(1):1-7. — View Citation
Saito H, Sakurai Y, Takamura A, Horio K. [Biliary endoprosthesis using Gore-Tex covered expandable metallic stents: preliminary clinical evaluation]. Nihon Igaku Hoshasen Gakkai Zasshi. 1994 Feb 25;54(2):180-2. Japanese. — View Citation
Shah RJ, Howell DA, Desilets DJ, Sheth SG, Parsons WG, Okolo P 3rd, Lehman GA, Sherman S, Baillie J, Branch MS, Pleskow D, Chuttani R, Bosco JJ. Multicenter randomized trial of the spiral Z-stent compared with the Wallstent for malignant biliary obstruction. Gastrointest Endosc. 2003 Jun;57(7):830-6. — View Citation
Warshaw AL, Fernández-del Castillo C. Pancreatic carcinoma. N Engl J Med. 1992 Feb 13;326(7):455-65. Review. — View Citation
Yoon WJ, Lee JK, Lee KH, Lee WJ, Ryu JK, Kim YT, Yoon YB. A comparison of covered and uncovered Wallstents for the management of distal malignant biliary obstruction. Gastrointest Endosc. 2006 Jun;63(7):996-1000. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the duration of stent patency of a covered vs. an uncovered biliary SEMS placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction. | The Kaplan-Meier method will be used to estimate stent patency in each group and the log-rank test will be used for an unadjusted comparison between groups. Then a Cox proportional hazard model will be constructed to compare time to stent occlusion adjusted for important potential confounders. Stent patency will be calculated in days and will represent the interval between the time of stent insertion and the time of its replacement or the death of the patient with concomitant cholangitis. | minimum follow-up: 4 months | No |
Primary | To evaluate complication rates of covered vs. uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction | Relationships between complication rates and stent type will be examined by the chi-square or the exact Fisher tests. Logistic regression will be used to compare stent complication rates adjusted for important potential confounders. | minimum follow-up: 4 months | Yes |
Secondary | To evaluate the quality of life before and after intervention with covered vs. uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction. | Health-related quality of life (HRQL) will be evaluated by a paired t-test to determine the impact of stent placement (i.e. compare baseline HRQL and month 3 HRQL) by Student's t -test to compare the differences in HRQL at baseline and 3 months between study groups. Linear regression models will be constructed to assess HQRL while adjusting for factors other than stent type. | 3 months | No |
Secondary | To evaluate the survival of patients treated with covered vs. uncovered biliary SEMS for the management of inoperable extrahepatic malignant biliary obstruction. | For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows will be used. | until death | No |
Secondary | To evaluate the cost-effectiveness of covered and uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction | Total direct costs for each study group will be compared and cost effectiveness modelled. For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows) will be used. |
until death | No |
Secondary | To determine the predictors of survival in patients in patients with inoperable extrahepatic malignant biliary obstruction managed with SEMS. | For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows will be used. | minimum follow-up: 4 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06101277 -
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)
|
N/A | |
Completed |
NCT02626195 -
Preoperative Nutritional Support in Malnutritional Cancer Patients
|
N/A | |
Completed |
NCT01401894 -
Perception Prognosis, Goals of Treatment, and Communication
|
N/A | |
Completed |
NCT00551096 -
Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04517448 -
Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
|
||
Recruiting |
NCT04644068 -
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05849480 -
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
|
Phase 1/Phase 2 | |
Completed |
NCT02703714 -
Pembrolizumab and GM-CSF in Biliary Cancer
|
Phase 2 | |
Completed |
NCT01853618 -
Tremelimumab With Chemoembolization or Ablation for Liver Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT05462314 -
Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
|
||
Recruiting |
NCT05517811 -
Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
|
||
Active, not recruiting |
NCT01661114 -
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
|
Phase 2 | |
Recruiting |
NCT01859728 -
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
|
Phase 2 | |
Withdrawn |
NCT04480190 -
Neoadjuvant Therapy in Biliary Adenocarcinoma
|
Phase 1 | |
Completed |
NCT00626158 -
Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers
|
Phase 1 | |
Terminated |
NCT04566133 -
Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC).
|
Phase 2 | |
Recruiting |
NCT02628067 -
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
|
Phase 2 | |
Terminated |
NCT00868998 -
GTX Regimen for Biliary Cancers
|
Phase 2 | |
Terminated |
NCT02908451 -
A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer
|
Phase 1 | |
Completed |
NCT01838109 -
Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery
|
N/A |