Partially Covered Metal Stents Efficacy in Biliary Drainage of Malignant Extrahepatic Biliary Obstruction (METARSI): a multicenter randomized controlled trial

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Aims The primary aim of this randomized trial was to compare stent patency in unresectable malignant biliary stricture after placement of partially covered metallic stent (PC-SEMS) vs uncovered metal stent (U-SEMS). Secondary aims were to evaluate the stents performance in terms of migration rate, patient survival in the absence of stent dysfunction, the incidence of early (within 7 days) or late (30 days) complications with these different stents types Methods Prospective multicenter randomized controlled and “non-profit” clinical trial. After determining the inclusion and exclusion criteria, a second investigator acceded the proper randomization list during the procedure. After stent placement (T0), biliary drainage was considered effective reaching bilirubin level less than 2 mg/dl (T1). Subsequently, patients were divided into two groups based on the possibility of oncological treatment: - in patients who were not resectable and cannot be treated with chemotherapy (UNFIT group), follow-up included blood tests and telephone/outpatient evaluation at 3, 9 and 12 months±3 weeks (T2); - in unresectable patients undergoing neo-adjuvant or palliative chemotherapy (FIT group) the follow-up included blood tests and telephone/outpatient evaluation at 3, 6, 9 and 12 months±3 weeks (T2). Results Between March 2021 and February 2023, 256 patients were randomized to receive an uncovered (n. 124) or a partially covered (n. 132) SEMS. Stent placement was successful in all enrolled patients.All the inserted stents were 10 mm in diameter. Within 7 days after stent insertion, two patients developed moderate pancreatitis resolved with medical treatment. Eight patients developed cholangitis: 4 patients in the PC-SEMS group were treated with antibiotic therapy alone, while 4 patients (2 in PC-SEMS and 2 in U-SEMS group), required an endoscopic re-intervention to insert a coaxial biliary plastic stent. Cholecystitis developed in two patients from the PC-SEMS group and required a second ERCP to remove the first stent and insert a new one.Late stent dysfunction occurred in 24 cases (12 patients in both groups). Tumor ingrowth with or without biliary sludge impaction was registered in 22 cases; Median time to late stent obstruction was 270 days (IQR 95-273) in the USEMS group and 193 days (IQR, 111-273) in the PC- SEMS group (p-value 0.78). Conclusions In conclusion our study showed no differences in terms of efficacy and safety between U-SEMS and PC-SEMS. To optimize stents performance, the development of devices that prevent migration, incomplete expansion, biofilm formation and tumor ingrowth are required [ 1 ] [ 2 ] [ 3 ] [ 4 ] [ 5 ] [ 6 ] [ 7 ] [ 8 ] [ 9 ] [ 10 ] [ 11 ] [ 12 ] [ 13 ] [ 14 ] [ 15 ] [ 16 ] [ 17 ] [ 18 ] [ 19 ] [ 20 ] [ 21 ] [ 22 ] [ 23 ] [ 24 ] [ 25 ] [ 26 ] [ 27 ] [ 28 ] [ 29 ] Publication History Article published online: 27 March 2025 © 2025. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

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