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

NCT04431427 | Unknown

• 1 other identifier: 05.2020
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Biliary Obstruction

Keywords

Malignant biliary obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of patency, migration and adverse events rate

  12 months

Study Arms (2)

Partially Covered Metal Stent Arm

ACTIVE COMPARATOR

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.

Device: Biliary drainage with PC-SEMS

Uncovered Metal Stent Arm

ACTIVE COMPARATOR

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.

Device: Biliary drainage with U-SEMS

Interventions

Biliary drainage with PC-SEMS DEVICE

partially covered metallic biliary stent insertion during ERCP

Partially Covered Metal Stent Arm

Biliary drainage with U-SEMS DEVICE

Uncovered metallic biliary stent insertion during ERCP

Uncovered Metal Stent Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients who had malignant biliary obstruction with a estimated survival \>4 months

You may not qualify if:

• 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)

Sponsors & Collaborators

• Santi Mangiafico: lead

Related 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.

  PMID: 26526122 RESULT

• 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.

  PMID: 8908550 RESULT

• 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.

  PMID: 26715823 RESULT

• 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.

  PMID: 30086596 RESULT

• 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.

  PMID: 27296728 RESULT

• 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.

  PMID: 22415652 RESULT

• 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.

  PMID: 26880897 RESULT

• 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.

  PMID: 26133200 RESULT

• 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.

  PMID: 24042190 RESULT

• 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.

  PMID: 31863440 RESULT

Central Study Contacts

SILVIA COCCA, MD

CONTACT

00393756213301; cocca.silvia@aou.mo.it

Santi Mangiafico, MD

CONTACT

mangiafico.santi@aou.mo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: February 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: August 1, 2022
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share