PMID- 37214030 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230523 IS - 2168-8184 (Print) IS - 2168-8184 (Electronic) IS - 2168-8184 (Linking) VI - 15 IP - 4 DP - 2023 Apr TI - Self-Expandable Metal Stent (SEMS) Versus Lumen-Apposing Metal Stent (LAMS) for Drainage of Pancreatic Fluid Collections: A Randomized Clinical Trial. PG - e37731 LID - 10.7759/cureus.37731 [doi] LID - e37731 AB - Background and aim Endoscopic ultrasound (EUS)-guided drainage is the gold standard approach for the treatment of encapsulated pancreatic collections (EPCs) including pseudocyst and walled-off pancreatic necrosis (WON), and is associated with an equivalent clinical efficacy to surgical drainage with fewer complications and less morbidity. Drainage may be achieved via several types of stents including a fully covered self-expandable metallic stent (SEMS) and lumen-apposing metal stent (LAMS). However, to date there have been no randomized trials to compare these devices. This study aimed to compare the efficacy and safety of the SEMS versus LAMS for EUS-guided drainage of EPCs. Methods A phase IIB randomized trial was designed to compare the SEMS versus LAMS for the treatment of EPCs. Technical success, clinical success, adverse events (AEs), and procedure time were evaluated. A sample size of 42 patients was determined. Results There was no difference between the two groups in technical (LAMS 80.95% vs 100% SEMS, p=0.107), clinical (LAMS 85.71% vs 95.24% SEMS, p=0.606) or radiological success (LAMS 92.86% vs 83.33% SEMS, p=0.613). There was no difference in AEs including stent migration rate and mortality. The procedure time was longer in the LAMS group (mean time 43.81 min versus 24.43 min, p=0.001). There was also a difference in the number of intra-procedure complications (5 LAMS vs 0 SEMS, p=0.048). Conclusion SEMS and LAMS have similar technical, clinical, and radiological success as well as AEs. However, SEMS has a shorter procedure time and fewer intra-procedure complications compared to non-electrocautery-enhanced LAMS in this phase IIB randomized controlled trial (RCT). The choice of the type of stent used for EUS drainage of EPCs should consider device availability, costs, and personal and local experience. CI - Copyright (c) 2023, Lera dos Santos et al. FAU - Lera Dos Santos, Marcos Eduardo AU - Lera Dos Santos ME AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - Proenca, Igor Mendonca AU - Proenca IM AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - de Moura, Diogo Turiani Hourneaux AU - de Moura DTH AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - Ribeiro, Igor Braga AU - Ribeiro IB AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - Matuguma, Sergio Eiji AU - Matuguma SE AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - Cheng, Spencer AU - Cheng S AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - de Freitas Junior, Joao Remi AU - de Freitas Junior JR AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - Luz, Gustavo de Oliveira AU - Luz GO AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - McCarty, Thomas R AU - McCarty TR AD - Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, USA. FAU - Jukemura, Jose AU - Jukemura J AD - Division of Gastrointestinal Surgery, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. FAU - de Moura, Eduardo Guimaraes Hourneaux AU - de Moura EGH AD - Servico de Endoscopia Gastrointestinal do Departamento de Gastroenterologia, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, BRA. LA - eng PT - Journal Article DEP - 20230417 PL - United States TA - Cureus JT - Cureus JID - 101596737 PMC - PMC10191807 OTO - NOTNLM OT - encapsulated pancreatic collection OT - eus-drainage OT - lams OT - lumen-apposing metal stent OT - pancreatic fluid collection OT - pancreatic pseudocyst OT - self-expandable metal stent OT - sems COIS- The authors have declared that no competing interests exist. EDAT- 2023/05/22 13:04 MHDA- 2023/05/22 13:05 PMCR- 2023/04/17 CRDT- 2023/05/22 12:06 PHST- 2023/03/15 00:00 [accepted] PHST- 2023/05/22 13:05 [medline] PHST- 2023/05/22 13:04 [pubmed] PHST- 2023/05/22 12:06 [entrez] PHST- 2023/04/17 00:00 [pmc-release] AID - 10.7759/cureus.37731 [doi] PST - epublish SO - Cureus. 2023 Apr 17;15(4):e37731. doi: 10.7759/cureus.37731. eCollection 2023 Apr.