- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431427
Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction (METARSI)
Partially Covered Metal Stents Efficacy in the Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction, a Multicentric Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Malignant obstructions of the bile duct are generally caused by: adenocarcinoma of the Vater ampulla, pancreas head cancer, cholangiocarcinoma and external compression secondary to lymph node (LN) metastasis. The management of jaundice and cholangitis, as a result of bile stenosis, is crucial in this group of patients. The most common and accepted method for biliary drainage is endoscopic stent placement with plastic stents or self-expandable metal stents (SEMS). In recent times, the use of SEMS has become more common as it provides longer times of patency and a reduced risk of adverse events such as cholangitic episodes. There are three types of metal stents: fully covered (FC), partially covered (PC) and uncovered (U). PC-SEMS have been recently introduced and compared to FC-SEMS they seem to have a lower risk of migration, however different randomized and non-randomized studies have compared the outcome of U-SEMS vs FC-SEMS with between uncovered and covered stents have produced different results regarding the cumulative patency of stents and endoscopic re-intervention rates. To date, there are few and discordant prospective data on the outcomes of PC-SEMS use in malignant biliary obstructions.
Therefore, the investigators will randomize the participants with biliary obstruction in 2 groups according to the type of stent used: PC-SEMS or U-SEMS (T0 timing).
Then the participants will be followed for total period of 12 months. 2 different timings of follow-up will be considered:
- T1: it will start after stent insertion. The biliary drainage will be considered effective, according to the European guidelines, when the bilirubin values will be < or = 2 mg/dl for a period of at least 6 weeks if the initial bilirubin values were higher than 10 mg/dl or 3 weeks if at the beginning were lower than 10 mg/dl; After this first phase, all the enrolled patients will be divided in 2 groups according to their "fitness" for chemiotherapy: FIT and UNFIT Group.
FIT group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study once every three months.
UNFIT Group: blood test (including total bilirubin, gamma-GT) will be done for follow-up study after 3, 9 and 12 months.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SILVIA COCCA, MD
- Phone Number: 00393756213301
- Email: cocca.silvia@aou.mo.it
Study Contact Backup
- Name: Santi Mangiafico, MD
- Email: mangiafico.santi@aou.mo.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
•The patients who had malignant biliary obstruction with a estimated survival >4 months
Exclusion Criteria:
- The patients who had resectable biliary malignancy
- The patients who had hilar obstruction
- The patients who had duodenal obstruction
- The patients who had International Normalized Ratio (INR)>1.5
- The patients who did not give informed consent
- The patients who had technically difficult structure for Endoscopic retrograde cholangiopancreatography (ERCP)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Partially Covered Metal Stent Arm
The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study.
Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent).
After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.
|
partially covered metallic biliary stent insertion during ERCP
|
Active Comparator: Uncovered Metal Stent Arm
The patients who had extra-hepatic malignant biliary obstruction will be enrolled in our study.
Enrolled patient will be randomized to two group (uncovered metallic stent vs. partially covered metallic stent).
After metallic biliary stent insertion, enrolled patients will be followed until bilirubin values will be under 2 mg/dl.
|
Uncovered metallic biliary stent insertion during ERCP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Re-intervention rate
Time Frame: 12 months
|
Evaluation in both arms of the re-intervention rate considered as any procedure needed for a new drainage of the biliary tree, endoscopic or percutaneous, to replace a dysfunctional stent.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of patency, migration and adverse events rate
Time Frame: 12 months
|
evaluation of patency, migration and adverse events rate for each arm
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bowlus CL, Olson KA, Gershwin ME. Evaluation of indeterminate biliary strictures. Nat Rev Gastroenterol Hepatol. 2016 Jan;13(1):28-37. doi: 10.1038/nrgastro.2015.182. Epub 2015 Nov 3. Erratum In: Nat Rev Gastroenterol Hepatol. 2017 Nov 02;:
- Reisman Y, Gips CH, Lavelle SM, Wilson JH. Clinical presentation of (subclinical) jaundice--the Euricterus project in The Netherlands. United Dutch Hospitals and Euricterus Project Management Group. Hepatogastroenterology. 1996 Sep-Oct;43(11):1190-5.
- Zorron Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonca EQ, Kondo A, Luz GO, Furuya Junior CK, Artifon EL. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(47):13374-85. doi: 10.3748/wjg.v21.i47.13374.
- Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Deviere J, Garcia-Cano J, Gyokeres T, Hassan C, Prat F, Siersema PD, van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018 Sep;50(9):910-930. doi: 10.1055/a-0659-9864. Epub 2018 Aug 7.
- Crippa S, Cirocchi R, Partelli S, Petrone MC, Muffatti F, Renzi C, Falconi M, Arcidiacono PG. Systematic review and meta-analysis of metal versus plastic stents for preoperative biliary drainage in resectable periampullary or pancreatic head tumors. Eur J Surg Oncol. 2016 Sep;42(9):1278-85. doi: 10.1016/j.ejso.2016.05.001. Epub 2016 May 24.
- Mukai T, Yasuda I, Nakashima M, Doi S, Iwashita T, Iwata K, Kato T, Tomita E, Moriwaki H. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci. 2013 Feb;20(2):214-22. doi: 10.1007/s00534-012-0508-8.
- Tsuboi T, Sasaki T, Serikawa M, Ishii Y, Mouri T, Shimizu A, Kurihara K, Tatsukawa Y, Miyaki E, Kawamura R, Tsushima K, Murakami Y, Uemura K, Chayama K. Preoperative Biliary Drainage in Cases of Borderline Resectable Pancreatic Cancer Treated with Neoadjuvant Chemotherapy and Surgery. Gastroenterol Res Pract. 2016;2016:7968201. doi: 10.1155/2016/7968201. Epub 2016 Jan 6.
- Yang MJ, Kim JH, Yoo BM, Hwang JC, Yoo JH, Lee KS, Kang JK, Kim SS, Lim SG, Shin SJ, Cheong JY, Lee KM, Lee KJ, Cho SW. Partially covered versus uncovered self-expandable nitinol stents with anti-migration properties for the palliation of malignant distal biliary obstruction: A randomized controlled trial. Scand J Gastroenterol. 2015;50(12):1490-9. doi: 10.3109/00365521.2015.1057219. Epub 2015 Jul 1.
- Kitano M, Yamashita Y, Tanaka K, Konishi H, Yazumi S, Nakai Y, Nishiyama O, Uehara H, Mitoro A, Sanuki T, Takaoka M, Koshitani T, Arisaka Y, Shiba M, Hoki N, Sato H, Sasaki Y, Sato M, Hasegawa K, Kawabata H, Okabe Y, Mukai H. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol. 2013 Nov;108(11):1713-22. doi: 10.1038/ajg.2013.305. Epub 2013 Sep 17.
- Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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