PMID- 37920889 OWN - NLM STAT- MEDLINE DCOM- 20240215 LR - 20240215 IS - 1440-1746 (Electronic) IS - 0815-9319 (Linking) VI - 39 IP - 2 DP - 2024 Feb TI - Endoscopic ultrasound-guided gallbladder drainage with long-term lumen-apposing metal stent indwell: 1-year results from a prospective nationwide observational study. PG - 360-368 LID - 10.1111/jgh.16392 [doi] AB - BACKGROUND AND AIM: This study aimed to determine safety and risk factors for adverse events (AEs) of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with long-term indwell of lumen-apposing metal stents (LAMS). METHODS: This study is a multicenter prospective observational study on consecutive high surgical-risk patients requiring gallbladder drainage who underwent EUS-GBD with LAMS over 12 months. Centralized telephone follow-up interviews were conducted every 3 months for 1 year. Patients were censored at LAMS removal, cholecystectomy, or death. AE-free survival was determined using log-rank tests. Cumulative risks were estimated using life-table analysis. RESULTS: Eighty-two patients were included (53.7% male, median [interquartile range] age of 84.6 [76.5-89.8] years, and 85.4% with acute cholecystitis). Technical success was achieved in 79 (96.3%), and clinical success in 73 (89%). No patient was lost to follow-up; 45 patients (54.9%) completed 1-year follow-up with in situ LAMS. Median (interquartile range) LAMS indwell time was 364 (47-367) days. Overall, 12 (14.6%) patients presented 14 AEs, including 5 (6.1%) recurrent biliary events (3 acute cholangitis, 1 mild acute pancreatitis, and 1 acute cholecystitis). Patients with pancreatobiliary malignancy had an increased risk of recurrent biliary events (33% vs 1.5%, P = 0.001). The overall 1-year cumulative risk of recurrent biliary events was 9.7% (4.1-21.8%). The 1-year risk of AEs and of severe AEs was 18.8% (11-31.2%) and 7.9% (3.3-18.2%), respectively. Pancreatobiliary malignancy was the single risk factor for recurrent biliary events; LAMS misdeployment was the strongest risk factor for AEs. CONCLUSIONS: Long-term LAMS indwell does not increase the risk of delayed AEs following EUS-GBD. CI - (c) 2023 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd. FAU - Bazaga, Sergio AU - Bazaga S AUID- ORCID: 0000-0002-2984-5176 AD - Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain. AD - Department of Medicine, Universitat Autonoma de Barcelona, Universitat Autonoma de Barcelona, Barcelona, Spain. FAU - Garcia-Alonso, Francisco Javier AU - Garcia-Alonso FJ AUID- ORCID: 0000-0002-1425-8534 AD - Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain. FAU - Aparicio Tormo, Jose Ramon AU - Aparicio Tormo JR AD - Hospital General Universitario de Alicante, Alicante, Spain. FAU - Martinez Moreno, Belen AU - Martinez Moreno B AD - Hospital General Universitario de Alicante, Alicante, Spain. FAU - Sanchiz, Vicente AU - Sanchiz V AD - Hospital Clinico Universitario de Valencia, Valencia, Spain. FAU - Gornals, Joan B AU - Gornals JB AD - Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Spain. FAU - Loras, Carme AU - Loras C AD - Department of Gastroenterology, Hospital Universitari Mutua Terrassa, Fundacio per la Recerca Mutua Terrassa, Terrassa, Spain. AD - Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Barcelona, Spain. FAU - Teran, Alvaro AU - Teran A AD - Hospital Universitario Marques de Valdecilla, Santander, Spain. FAU - Vazquez-Sequeiros, Enrique AU - Vazquez-Sequeiros E AD - Endoscopy Unit, Department of Gastroenterology and Hepatology, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain. FAU - Pedraza Sanz, Rafael AU - Pedraza Sanz R AD - Hospital General Universitario de Castellon, Castellon de la Plana, Spain. FAU - Subtil, Jose Carlos AU - Subtil JC AD - Department of Gastroenterology, Endoscopy Unit, University of Navarra Clinic, University of Navarra, Pamplona, Spain. FAU - Perez-Millan, Antonio AU - Perez-Millan A AD - Hospital General Rio Carrion, Palencia, Spain. FAU - Uceda Porta, Francisco AU - Uceda Porta F AD - Hospital General Universitario de Elche, Alicante, Spain. FAU - Vila, Juan J AU - Vila JJ AD - Complejo Hospitalario de Navarra, Pamplona, Spain. FAU - de la Serna-Higuera, Carlos AU - de la Serna-Higuera C AD - Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain. FAU - Couto-Worner, Ignacio AU - Couto-Worner I AD - Complexo Hospitalario Universitario de A Coruna, A Coruna, Spain. FAU - Guarner-Argente, Carlos AU - Guarner-Argente C AD - Department of Medicine, Universitat Autonoma de Barcelona, Universitat Autonoma de Barcelona, Barcelona, Spain. AD - Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Universitat Autonoma de Barcelona, Barcelona, Spain. FAU - Perez-Miranda, Manuel AU - Perez-Miranda M AD - Department of Gastroenterology, Hospital Universitario Rio Hortega, Valladolid, Spain. CN - RNPAL (Registro nacional de protesis de aposicion luminal, national lumen-apposing metal stent registry) study group LA - eng GR - INT_M_12_23/Gerencia Regional de Salud, Junta de Castilla y Leon/ GR - 1992/A/19/Gerencia Regional de Salud, Junta de Castilla y Leon/ PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20231103 PL - Australia TA - J Gastroenterol Hepatol JT - Journal of gastroenterology and hepatology JID - 8607909 SB - IM MH - Humans MH - Male MH - Aged MH - Aged, 80 and over MH - Female MH - Acute Disease MH - Prospective Studies MH - Treatment Outcome MH - *Pancreatitis/epidemiology/etiology MH - Endosonography/adverse effects/methods MH - *Cholecystitis, Acute MH - Drainage/adverse effects/methods MH - Stents MH - Ultrasonography, Interventional MH - *Neoplasms/etiology OTO - NOTNLM OT - EUS-guided gallbladder drainage (EUS-GBD) OT - endoscopic ultrasound OT - lumen-apposing metal stent (LAMS) OT - prospective nationwide observational study EDAT- 2023/11/03 06:43 MHDA- 2024/02/15 06:43 CRDT- 2023/11/03 04:09 PHST- 2023/10/10 00:00 [revised] PHST- 2023/08/27 00:00 [received] PHST- 2023/10/12 00:00 [accepted] PHST- 2024/02/15 06:43 [medline] PHST- 2023/11/03 06:43 [pubmed] PHST- 2023/11/03 04:09 [entrez] AID - 10.1111/jgh.16392 [doi] PST - ppublish SO - J Gastroenterol Hepatol. 2024 Feb;39(2):360-368. doi: 10.1111/jgh.16392. Epub 2023 Nov 3.