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Open Access
CC BY 4.0 · Endosc Int Open
DOI: 10.1055/a-2795-7703
Original article

Partially Covered or Uncovered Metal Stent Efficacy in Malignant Unresectable Distal Biliary Obstruction (METARSI): a randomized multicenter trial

Authors

  • Silvia Cocca 

    1   Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Flavia Pigò

    1   Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Helga Bertani 

    2   Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena Policlinico di Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Roberta Rea

    3   Digestive Endoscopy, Campus Bio-Medico University Hospital, Rome, Italy (Ringgold ID: RIN220431)

  • Giuseppina Pontillo

    4   UOC Endoscopia Digestiva, AOU S. Giovanni di Dio e Ruggi d'Aragona, , plesso "Gaetano Fucito", Mercato San Severino (SA), Salerno, Italy

  • Michele Campigotto

    5   Gastroenterologia ed Endoscopia Digestiva, Ospedale Santa Maria di Ca Foncello, Treviso, Italy (Ringgold ID: RIN18703)

  • Giuseppe Grande 

    6   Gastrointestinal and Digestive Unit, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Salvatore Russo

    7   Gastroenterology and Digestive Endoscopy Unit, University Hospital Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Margherita Marocchi

    1   Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Marinella Lupo

    1   Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy (Ringgold ID: RIN208968)

  • Gian Maria Prati

    8   Department of Gastroenterology and Hepatology, AUSL Piacenza, Piacenza, Italy (Ringgold ID: RIN154818)

  • Giovanni Aragona

    9   Gastroenterology and Hepatology Unit, AUSL Piacenza, Piacenza, Italy (Ringgold ID: RIN154818)

  • Raffaele Manta

    10   Gastroenterology and Digestive Endoscopy Unit, ASL Toscana Nord-Ovest, Perugia, Italy

  • Carmelo Barbera

    11   Gastroenterology and Digestive Endoscopy Unit, USL Teramo, Teramo, Italy

  • Fabio Monica

    12   Gastroenterology and Endoscopy Unit, Ospedali di Trieste, Trieste, Italy

  • Francesco Di Matteo

    13   Digestive Diseases, GI Endoscopy Unit, Campus Bio-Medico University Hospital, Rome, Italy (Ringgold ID: RIN220431)

  • Rita Conigliaro

    14   Digestive Endoscopy Unit, Azienda Ospedaliero-Universitaria di Modena Ospedale Civile di Baggiovara, Modena, Italy (Ringgold ID: RIN220340)

  • Santi Mangiafico

    15   Gastroenterology and Endoscopy Unit, Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco, Catania, Italy (Ringgold ID: RIN207758)

Clinical Trial:

Registration number (trial ID): NCT04431427., Trial registry: EU Clinical Trials Register (https://www.clinicaltrialsregister.eu), Type of Study: Randomized, Multi-Center Study


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Background/Study Aim: There is no consensus regarding the optimal selection of self-expandable stents (SEMS) for biliary drainage with endoscopic retrograde cholangiopancreatography (ERCP). This study compares stent dysfunction, patient survival and adverse events in patients with unresectable malignant distal biliary strictures (DBS) treated with ERCP, randomized to partially covered (PC-) or uncovered (U-) SEMS. Patients/Materials and Methods: A prospective multicenter randomized controlled trial in adult patients with DBS (March 2021 - February 2023) with a 12-month follow-up, was performed. Analyses were conducted according to intention-to-treat (ITT) and per-protocol (PP) principles. Procedural and post-procedural outcomes were evaluated using PP analyses and stent patency was evaluated with Kaplan-Meier analysis. Results: Among 261 patients, 130 were randomized to PC-SEMS and 131 to U-SEMS. Baseline features were similar between groups (mean age 73 ± 11 years; 51% male). Most strictures were due to pancreatic adenocarcinoma (75%), and 49% had metastatic disease. Overall, stent dysfunction was comparable (11% vs 14%; P = .70). No significant differences were observed for patient survival (108 vs 100 days). A trend toward higher procedure-related complications was noted with PC-SEMS (2% vs 7%; not significant). Conclusion: PC-SEMS and U-SEMS in unresectable DBS showed comparable patency, survival, and stent dysfunction rates, with tumor ingrowth rarely observed and a trend toward more procedure-related complications in PC-SEMS. In this group with limited survival, there was no observed patency advantage with PC-SEMS. Potential benefit of PC-SEMS in populations with longer prognosis warrants further study.



Publication History

Received: 02 June 2025

Accepted after revision: 22 January 2026

Accepted Manuscript online:
23 January 2026

© . The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Bibliographical Record
Silvia Cocca, Flavia Pigò, Helga Bertani, Roberta Rea, Giuseppina Pontillo, Michele Campigotto, Giuseppe Grande, Salvatore Russo, Margherita Marocchi, Marinella Lupo, Gian Maria Prati, Giovanni Aragona, Raffaele Manta, Carmelo Barbera, Fabio Monica, Francesco Di Matteo, Rita Conigliaro, Santi Mangiafico. Partially Covered or Uncovered Metal Stent Efficacy in Malignant Unresectable Distal Biliary Obstruction (METARSI): a randomized multicenter trial. Endosc Int Open ; 0: a27957703.
DOI: 10.1055/a-2795-7703