Eficacia y seguridad del drenaje endoscópico transmural en pacientes con colecciones líquidas pancreáticas sintomáticas no tributarios a drenaje endoscópico transpapilar / Efficacy and safety of transmural endoscopic drainage in patients with symptomatic pancreatic fluid collections not amenable to transpapillary endoscopic drainage

ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021 y ampliada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 97-IETSI-ESSALUD2022, se ha elaborado el presente dictamen sobre la evaluación de la eficacia y seguridad del drenaje endoscópico transmural en pacientes con colecciones líquidas pancreáticas (CLP) sintomáticas no tributarios a drenaje endoscópico transpapilar. ASPECTOS GENERALES Los aspectos relacionados con la epidemiología, etiología, clasificación, y sintomatología de las CLP han sido previamente detallados en el Dictamen Preliminar de Evaluación de Tecnología Sanitaria N° 002-DETS-IETSI-2021 Eficacia y Seguridad del drenaje endoscópico con prótesis LAMS en pacientes adultos con colecciones líquidas pancreáticas sintomáticas (Instituto de Evaluación de Tecnologías en Salud e Investigación 2021). 3 Tipo de drenaje realizado a partir de la colocación de un stent a nivel de la papila (ampolla de Vater). Este sitio anatómico se encuentra posicionado en la unión entre el conducto biliar y el conducto pancreático, y es donde se produce el vaciamiento de la bilis y enzimas digestivas hacia el intestino delgado. El drenaje de las CLP sintomáticas puede ser realizado mediante los abordajes quirúrgico, percutáneo y endoscópico (Mahapatra and Garg 2019). Sin embargo, los especialistas solicitantes de la institución, señalan que el abordaje endoscópico podría ofrecer un mejor balance riesgo beneficio, con menor tiempo de recuperación, y menor tasa de complicaciones relacionadas, al ser un método menos invasivo que los procedimientos de drenaje quirúrgico y percutáneo. El drenaje endoscópico puede ser realizado por vía transmural o transpapilar3, o una combinación de ambas; sin embargo, la aplicación del drenaje transpapilar requiere que exista comunicación entre la CLP y el conducto pancreático principal, lo cual no ocurre en todos los casos (Tan et al. 2021). Así, en escenarios donde el drenaje transpapilar, ya sea de forma individual o combinada, no es posible, se puede optar por el drenaje de tipo transmural. METODOLOGÍA: Se llevó a cabo una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del drenaje endoscópico transmural en pacientes con CLP sintomáticas no tributarios a drenaje endoscópico transpapilar. La búsqueda bibliográfica se realizó en las bases de datos PubMed, The Cochrane Library. Web of Science y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan ETS y G PC, incluyendo el IETSI, Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), la Agency for Healthcare Research and Quality's (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de Incorporaóáo de Tecnologias no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (lOWiG, por sus siglas en alemán), y Hauté Autorité de Santé (HAS). Además, se realizó una búsqueda de GPC en las páginas web de las principales t\sociedades o instituciones especializadas el manejo de patologías de la cavidad .11 abdominal y gastrointestinales, tales como: European Society of Gastrointestinal . Endoscopy (ESGE), American College of Gastroenterology (ACG), World Gastroenterology Organisation (WGO), y la American Society for Gastrointestinal Endoscopy (ASGE). Finalmente, se realizó una búsqueda en las páginas web de ClinicalTrials.govy la International Clinical Trials Registry Platform, en busca de estudios clínicos en curso o aún no publicados. RESULTADOS: Luego de la búsqueda bibliográfica con fecha 07 de julio del 2022, se incluyeron cuatro GPC, y tres E0. Las GPC incluidas fueron elaboradas por: la Korean Society of Gastrointestinal Endoscopy (KSGE), la Society of Gastrointestinal Endoscopy of India/Indian Endoscopic Ultrasound Club (SGEI/EUS Club), y la European Society of Gastrointestinal Endoscopy (ESGE) (Shah et al. 2021, Oh et al. 2021, Arvanitakis et al. 2018, Dumonceau et al. 2019). Finalmente, se incluyeron tres EO comparativos: Kumar et al. 2014 (Kumar, Conwell, and Thompson 2014), Keane et al. 2016 (Keane et al. 2016), y Tan et al. 2018 (Tan et al. 2018). No se identificaron ETS, revisiones sistemáticas (RS) con o sin metanálisis (MA), ni ECA que cumplieran con los criterios de inclusión para la presente evaluación. CONCLUSIÓN: Por todo lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación aprueba la incorporación del drenaje endoscópico transmural como procedimiento, para su uso en pacientes adultos con necrosis amuralladas sintomáticas, no tributarios a drenaje endoscópico transpapilar. Cabe señalar que, para poder utilizar este procedimiento en la institución, se requiere de la evaluación previa de la eficacia y seguridad comparativa de los dispositivos que permiten la aplicación del drenaje transmural, para determinar técnicamente cual sería la que ofrece el mayor beneficio clínico para la población de interés. En cuanto a la población de pacientes con pseudoquistes pancreáticos sintomáticos, no tributarios a drenaje transpapilar, no se aprueba el uso de drenaje transmural, debido a que, no se identificaron argumentos técnicos suficientes para sustentar su uso en estos pacientes.

Clinical outcomes of acute pancreatitis in elderly patients: An experience of single tertiary center.

BACKGROUND: Although well understanding the course of diseases in geriatric population is of paramount importance in order to provide the optimal treatment, there is only a few studies with controversial results that have been conducted about the course and outcomes of acute pancreatitis (AP) in elderly. We aimed to compare clinical outcomes of AP disease in geriatric age group and to evaluate the risk factors affecting outcomes. METHODS: A total of 336 patients diagnosed with AP, hospitalized and followed-up in our hospital between July/2013-February/2019 were included in this study. Patients aged 65 years and over were assessed as elderly population. Patients' demographic data, comorbidities, duration of hospitalization, local systemic complications, and mortality rates were documented. RESULTS: 196(58.3%) of the patients were female with a mean age of 54.1 ± 17.9 years. The number of patients was 114(33.9%) in the elderly group and 222(66.1%) in the non-elderly group. Although there was no significant difference between both groups in terms of abscess, pseudocyst and necrosis, pancreatic necrosis and systemic complications were higher in the elderly group (p < 0.05). The durations of oral intake and hospitalization were longer, the mortality rate and severity of AP according to the Ranson and Atlanta criteria were significantly higher in the geriatric population (p < 0.05). In addition, age and severity of AP were found to be independent predictive factors of developing complications. CONCLUSIONS: Early recognition of AP is important in the geriatric population. Clinical and laboratory investigations, and early diagnosis in severe patients will be largely helpful in providing close follow-up and the optimal treatment.

Seudoquiste mediastinal y fistulización pleural, excepcional complicación de una pancreatitis / Mediastinal pseudocyst and pleural fistulization, exceptional complication of pancreatitis

Resumen Introducción: Las complicaciones torácicas secundarias a pancreatitis aguda son excepcionales y más aún la presencia de un pseudoquiste mediastinal. Caso Clínico: Hombre de 36 años. Consumidor de marihuana y alcohol. Historia de 6 meses de dolor abdominal y adelgazamiento de 20 kilos. Instalando en la evolución sintomatología respiratoria. Discusión: Se discuten las formas de presentación de esta entidad. Sus etiologías más frecuentes. Se hace énfasis en el rol de la imagenología así como en el análisis del líquido pleural. El enfoque terapéutico es conservador al inicio y en algunos pacientes es quirúrgico en la evolución; con diversas opciones.

Introduction: The thoracic complications secondary to acute pancreatitis are exceptional and even more so the presence of a mediastinal pseudocyst. Case report: 36 year old man. Marijuana and alcohol consumer. History of 6 months of abdominal pain and weight loss of 20 kilos. Installing respiratory symptomatology evolution. Discussion: The forms of presentation of this entity are discussed. Its most frequent etiologies. Emphasis is placed on the role of imaging as well as the analysis of pleural fluid. The therapeutic approach is conservative at the beginning and in some patients it is surgical during evolution; with several options.

Management of pancreatic collections: an update.

Pancreatic fluid collections frequently occur in the context of moderate and severe acute pancreatitis, and may also appear as a complication of chronic pancreatitis, pancreatic surgery or trauma. It is essential to adhere to the Atlanta classification nomenclature that subclassifies them into four categories (acute peripancreatic fluid collections, acute necrotic collections, pseudocysts, and walled-off necrosis) since it has an impact on prognosis and management. Pseudocysts and walled-off pancreatic necrosis are encapsulated pancreatic fluid collections characterized by a surrounding inflammatory wall, which typically develops three to four weeks after the onset of acute pancreatitis. Most pancreatic fluid collections resolve spontaneously and do not require intervention. However, when they become symptomatic or complicated drainage is indicated, and endoscopic ultrasound-guided drainage has become first-line treatment of encapsulated collections. Drainage of pseudocysts is relatively straightforward due to their liquid content. However, in walled-off necrosis the presence of solid necrotic debris can make treatment more challenging and therefore multidisciplinary management in experienced centers is recommended, being a step-up approach the current standard of care. In this review, we aim to address the management of pancreatic fluid collections with an especial focus on endoscopic drainage.

Pancreatic fluid collections: Clinical manifestations, diagnostic evaluation and management.

Pancreatic fluid collections (PFC), including pancreatic pseudocysts and walled-off pancreatic necrosis, are a known complication of severe acute pancreatitis. A majority of the PFCs remain asymptomatic and resolve spontaneously. However, some PFCs persist and can become symptomatic. Persistent PFCs can also cause further complications such as the gastric outlet, intestinal, or biliary obstruction and infection. Surgical interventions are indicated for the drainage of symptomatic sterile and infected PFCs. Management of PFCs has evolved from a primarily surgical or percutaneous approach to a less invasive endoscopic approach. Endoscopic interventions are associated with improved outcomes with lesser chances of complications, faster recovery time, and lower healthcare utilization. Endoscopic ultrasound-guided drainage of PFCs using lumen-apposing metal stents has become the preferred approach for the management of symptomatic and complicated PFCs.

Endoscopic versus laparoscopic drainage of pseudocyst and walled-off necrosis following acute pancreatitis: a randomized trial.

BACKGROUND: Pancreatic fluid collections (PFC) may develop following acute pancreatitis (AP). Endoscopic and laparoscopic internal drainage are accepted modalities for drainage of PFCs but have not been compared in a randomized trial. Our objective was to compare endoscopic and laparoscopic internal drainage of pseudocyst/walled-off necrosis following AP. PATIENTS AND METHODS: Patients with symptomatic pseudocysts or walled-off necrosis suitable for laparoscopic and endoscopic transmural internal drainage were randomized to either modality in a randomized controlled trial. Endoscopic drainage comprised of per-oral transluminal cystogastrostomy. Additionally, endoscopic lavage and necrosectomy were done following a step-up approach for infected collections. Surgical laparoscopic cystogastrostomy was done for drainage, lavage, and necrosectomy. Primary outcome was resolution of PFCs by the intended modality and secondary outcome was complications. RESULTS: Sixty patients were randomized, 30 each to laparoscopic and endoscopic drainage. Both groups were comparable for baseline characteristics. The initial success rate was 83.3% in the laparoscopic and 76.6% in the endoscopic group (p = 0.7) after the index intervention. The overall success rate of 93.3% (28/30) and 90% (27/30) in the laparoscopic and endoscopic groups respectively was also similar (p = 1.0). Two patients in the laparoscopic group required endoscopic cystogastrostomy for persistent collections. Similarly, two patients in the endoscopic group required laparoscopic drainage. Postoperative complications were comparable between the groups except for higher post-procedure infection in the endoscopic group (19 vs. 9; p = 0.01) requiring endoscopic re-intervention. CONCLUSIONS: Endoscopic and laparoscopic techniques have similar efficacy for internal drainage of suitable pancreatic fluid collections with < 30% debris. The choice of procedure should depend on available expertise and patient preference.

Two's a Charm: Endoscopic Therapy of Multiple Pancreatic Pseudocysts.

Pancreatic pseudocysts commonly complicate acute pancreatitis. They can evolve either asymptomatically or with important symptoms. Treatment can be surgical, endoscopic, or percutaneous. The authors present a case report of a 78-year-old man who developed symptoms of an acute abdomen during hospitalization. A CT scan showed two pancreatic pseudocysts (diameters 10 cm and 7.5 cm) that were successfully drained endoscopically. Multiple pancreatic pseudocysts can be treated successfully via an endoscopic approach.

Overview and comparison of guidelines for management of pancreatic cystic neoplasms.

Pancreatic cysts are identified at an increasing frequency. Although mucinous cystic neoplasms represent a pre-malignant condition, the majority of these lesions do not progress to cancer. Over the last 10 years several societies have established guidelines for the diagnosis, initial evaluation and surveillance of these lesions. Here we provide an overview of five commonly used guidelines: 2015 American Gastroenterological Association, 2017 International Association of Pancreatology, American College of Gastroenterology 2018, European Study Group and American College of Radiology. We describe the similarities and differences between the methods used to formulate these guidelines, the population they target and their approaches towards initial evaluation and surveillance of cystic lesions.

A novel lumen-apposing metal stent with an anti-reflux valve for endoscopic ultrasound-guided drainage of pseudocysts and walled-off necrosis: A pilot study.

BACKGROUND: Pancreatic pseudocysts (PC) and walled-off necrosis (WON) are common complications of severe pancreatitis. Endoscopic ultrasound (EUS)-guided drainage has replaced surgery as the standard treatment for PC/WON. We developed a novel lumen-apposing metal stent (LAMS) with an anti-reflux valve to prevent infectious complications caused by food reflux into the cyst cavity. This retrospective study investigated the efficacy and safety of EUS-guided drainage using this LAMS. METHODS: We investigated and compared the treatment outcomes and complications rates between EUS-guided drainage using a novel LAMS (n = 10) versus plastic stents (n = 18) from December 2013 to October 2016. Technical success was defined as successful stent placement without immediate complications. Clinical success was defined as resolution of the PC/WON and disappearance of symptoms. RESULTS: Among 10 patients in LAMS group, 4 patients had complicated PC and 6 patients had WON. In the plastic stent group, 15 and 3 patients had PC and WON, respectively. The median fluid collection size before treatment was 82.5 (interquartile range [IQR], 60.75-118.25) mm and 92.0 (IQR, 75.75-130.25) mm in the LAMS and plastic stent groups, respectively. There were no statistically significant differences in technical success rates (90% vs. 94.4%; p = 0.999), clinical success rates (80% vs. 77.8%; p = 0.999), and complication rates (20% vs. 27.8%; p = 0.999) between the two groups. CONCLUSIONS: Treatment outcomes of EUS-guided drainage using a novel LAMS were feasible despite the significantly high proportion of WON. The LAMS allowed acceptable treatment outcomes for EUS-guided drainage.

Pancreatic enzyme replacement for refractory multiple large pancreatic cysts.

The case was a 47-year-old male with a long history of alcohol abuse but he had stopped drinking alcohol after the first attack of acute pancreatitis. He was referred due to recurrent pancreatitis complicated by pancreatic pseudocysts. Computed tomography (CT) and magnetic resonance cholangiopancreatography (MRCP) imaging was suggestive of chronic pancreatitis and pancreatolithiasis, with multiple large pseudocysts in the head and tail of pancreas.