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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04431427
Other study ID # 05.2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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