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Gornals JB, Velasquez-Rodriguez JG, Bas-Cutrina F, Garcia Garcia De Paredes A, Esteban JM, Teran A, Gonzalez-Huix F, Perez-Miranda M, Guarner-Argente C, Vila JJ, Garcia-Sumalla A, Foruny JR, Fisac-Vazquez J, Moris M, Miquel-Salas I, De-la-Serna Higuera C, Murzi-Pulgar M, Sanchez-Yague A, Salord S, Ruiz-Osuna S, Busquets J, Sanllorente-Melenchon M, Videla S, Moreno R, Tebe-Cordomi C, Hereu P, Vazquez-Sequeiros E. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial. Surg Endosc 2024; 38:2148-2159. [PMID: 38448625 DOI: 10.1007/s00464-024-10699-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/02/2023] [Accepted: 01/14/2024] [Indexed: 03/08/2024]
Abstract
BACKGROUND Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. METHODS This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n = 31) or the LAMS group (n = 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. CLINICALTRIALS gov, NCT03100578. RESULTS A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88-2.25; p = 0.218) and in the long term (RR, 1.2; 95% CI 0.92-1.58; p = 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p = 0.003). The hospital admission after the index procedure (median difference, - 10 [95% CI - 17.5, - 1]; p = 0.077) and global hospitalization (median difference - 4 [95% CI - 33, 25.51]; p = 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08-0.83], p = 0.015). CONCLUSIONS The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. TRIAL REGISTRATION NUMBER ClinicalTrials.gov, NCT03100578.
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Affiliation(s)
- Joan B Gornals
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Feixa Llarga s/n, 08907, L'Hospitalet, Barcelona, Catalonia, Spain.
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain.
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.
| | - Julio G Velasquez-Rodriguez
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Feixa Llarga s/n, 08907, L'Hospitalet, Barcelona, Catalonia, Spain
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
| | - Francesc Bas-Cutrina
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Feixa Llarga s/n, 08907, L'Hospitalet, Barcelona, Catalonia, Spain
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
| | - Ana Garcia Garcia De Paredes
- Endoscopy Unit, Gastroenterology and Hepatology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain
- Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Jose-Miguel Esteban
- Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico San Carlos, Madrid, Spain
| | - Alvaro Teran
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Marqués de Valdecilla, Santander, Spain
| | - Ferran Gonzalez-Huix
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Arnau de Vilanova, Lleida, Catalonia, Spain
| | - Manuel Perez-Miranda
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain
| | - Carlos Guarner-Argente
- Endoscopy Unit, Digestive Pathology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain
| | - Juan J Vila
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario de Navarra, Pamplona, Spain
| | - Albert Garcia-Sumalla
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Feixa Llarga s/n, 08907, L'Hospitalet, Barcelona, Catalonia, Spain
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
| | - Jose Ramon Foruny
- Endoscopy Unit, Gastroenterology and Hepatology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain
- Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
| | - Joaquin Fisac-Vazquez
- Endoscopy Unit, Department of Digestive Diseases, Hospital Clínico San Carlos, Madrid, Spain
| | - Maria Moris
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitario Marqués de Valdecilla, Santander, Spain
| | - Isabel Miquel-Salas
- Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Arnau de Vilanova, Lleida, Catalonia, Spain
| | | | - Marianette Murzi-Pulgar
- Endoscopy Unit, Digestive Pathology Department, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Catalonia, Spain
| | - Andres Sanchez-Yague
- Endoscopy Unit, Department of Digestive Diseases, Hospital Costa del Sol, Marbella, Spain
| | - Silvia Salord
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Hepato-Bilio-Pancreatic Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Sandra Ruiz-Osuna
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Radiology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Juli Busquets
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Hepato-bilio-Pancreatic Unit, Department of General Surgery, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Mireia Sanllorente-Melenchon
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Clinical Research and Clinical Trial Unit (UICEC), Plataforma Spanish Clinical Research Network (SCRen), Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Sebas Videla
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Clinical Research and Clinical Trial Unit (UICEC), Plataforma Spanish Clinical Research Network (SCRen), Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
- Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Ramon Moreno
- Economics and Finance Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Cristian Tebe-Cordomi
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Biostatistics Department, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
| | - Pilar Hereu
- Universitat de Barcelona (UB), Barcelona, Catalonia, Spain
- Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain
- Clinical Research and Clinical Trial Unit (UICEC), Plataforma Spanish Clinical Research Network (SCRen), Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
- Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Barcelona, Catalonia, Spain
| | - Enrique Vazquez-Sequeiros
- Endoscopy Unit, Gastroenterology and Hepatology Department, Hospital Universitario Ramon y Cajal, Madrid, Spain
- Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
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Zerem E, Kurtcehajic A, Kunosić S, Zerem Malkočević D, Zerem O. Current trends in acute pancreatitis: Diagnostic and therapeutic challenges. World J Gastroenterol 2023; 29:2747-2763. [PMID: 37274068 PMCID: PMC10237108 DOI: 10.3748/wjg.v29.i18.2747] [Citation(s) in RCA: 20] [Impact Index Per Article: 10.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2023] [Revised: 02/07/2023] [Accepted: 04/18/2023] [Indexed: 05/11/2023] Open
Abstract
Acute pancreatitis (AP) is an inflammatory disease of the pancreas, which can progress to severe AP, with a high risk of death. It is one of the most complicated and clinically challenging of all disorders affecting the abdomen. The main causes of AP are gallstone migration and alcohol abuse. Other causes are uncommon, controversial and insufficiently explained. The disease is primarily characterized by inappropriate activation of trypsinogen, infiltration of inflammatory cells, and destruction of secretory cells. According to the revised Atlanta classification, severity of the disease is categorized into three levels: Mild, moderately severe and severe, depending upon organ failure and local as well as systemic complications. Various methods have been used for predicting the severity of AP and its outcome, such as clinical evaluation, imaging evaluation and testing of various biochemical markers. However, AP is a very complex disease and despite the fact that there are of several clinical, biochemical and imaging criteria for assessment of severity of AP, it is not an easy task to predict its subsequent course. Therefore, there are existing controversies regarding diagnostic and therapeutic modalities, their effectiveness and complications in the treatment of AP. The main reason being the fact, that the pathophysiologic mechanisms of AP have not been fully elucidated and need to be studied further. In this editorial article, we discuss the efficacy of the existing diagnostic and therapeutic modalities, complications and treatment failure in the management of AP.
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Affiliation(s)
- Enver Zerem
- Department of Medical Sciences, The Academy of Sciences and Arts of Bosnia and Herzegovina, Sarajevo 71000, Bosnia and Herzegovina
| | - Admir Kurtcehajic
- Department of Gastroenterology and Hepatology, Plava Medical Group, Tuzla 75000, Bosnia and Herzegovina
| | - Suad Kunosić
- Department of Physics, Faculty of Natural Sciences and Mathematics, University of Tuzla, Tuzla 75000, Bosnia and Herzegovina
| | - Dina Zerem Malkočević
- Department of Internal Medicine, Cantonal Hospital “Safet Mujić“ Mostar, Mostar 88000, Bosnia and Herzegovina
| | - Omar Zerem
- Department of Internal Medicine, Cantonal Hospital “Safet Mujić“ Mostar, Mostar 88000, Bosnia and Herzegovina
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