Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction

Biliary Obstruction Clinical Trial

— METARSI  

Official title:

Partially Covered Metal Stents Efficacy in the Biliary Drainage of Malignant Extra-hepatic Biliary Obstruction, a Multicentric Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04431427
• Other study ID #: 05.2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: August 2022

Study information

• Verified date: January 2021
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: SILVIA COCCA, MD
• Phone: 00393756213301
• Email: cocca.silvia[@]aou.mo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Malignant obstructions of the bile duct are not rare. The most common and accepted method for biliary drainage is endoscopic stent placement. 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, although data in the literature are discordant. 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. After metallic biliary stent insertion, enrolled patients will be followed for 12 months.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Biliary Obstruction
• Cholestasis, Extrahepatic

Intervention

Device:
• Biliary drainage with PC-SEMS
partially covered metallic biliary stent insertion during ERCP
• Biliary drainage with U-SEMS
Uncovered metallic biliary stent insertion during ERCP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santi Mangiafico

References & Publications (10)

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. Review. Erratum in: Nat Rev Gastroenterol Hepatol. 2017 Nov 02;:. — View Citation

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 — View Citation

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 — View Citation

Dumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, Vanbiervliet G, Costamagna G, Devière J, García-Cano J, Gyökeres T, Hassan C, Prat F, Siersema PD, van Hooft JE. Endoscopic biliary stenting: indications, choice of stents, an — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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 Neoadju — View Citation

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 — View Citation

Zorrón Pu L, de Moura EG, Bernardo WM, Baracat FI, Mendonça EQ, Kondo A, Luz GO, Furuya Júnior CK, Artifon EL. Endoscopic stenting for inoperable malignant biliary obstruction: A systematic review and meta-analysis. World J Gastroenterol. 2015 Dec 21;21(4 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-intervention rate	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	Evaluation of patency, migration and adverse events rate	evaluation of patency, migration and adverse events rate for each arm	12 months