Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis

Официальное название

Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)

Обзор

Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.

Подробное описание

Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.

Вмешательства

• Процедура Immediate necrosectomy
  Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the
• Процедура Step-up approach
  Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the step-up approach group, an additional interventional procedure will be withheld for

Первичные конечные точки

• Time to clinical success from randomization [Срок оценки: Six months]

Вторичные конечные точки (12)

• Adverse events [Срок оценки: Five years]
• Mortality [Срок оценки: Five years]
• Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage) [Срок оценки: One day]
• Incidence of biliary and gastrointestinal stricture [Срок оценки: Five years]
• Number and time of interventions [Срок оценки: Six months]
• Indwelling time of endoscopic and percutaneous drainage [Срок оценки: Six months]
• Success rate and operation time of surgical procedures [Срок оценки: Six months]
• Hospital stay and ICU stay [Срок оценки: Six months]
• Duration of antibiotics administration [Срок оценки: Six months]
• Cost of interventions and hospital stay [Срок оценки: Six months]
• Recurrence of WON [Срок оценки: Five years]
• Time to recurrence of WON [Срок оценки: Five years]

Критерии участия

Критерии включения

• Patients with WON defined according to the revised Atlanta classification
• The longest diameter of WON is 4 cm or larger
• Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
• Patients who need drainage for WON
• Age of 18 years or older
• Patients or their representatives provide informed consent
• Patients who visit or are hospitalized at the participating institutions

Критерии исключения

• WON inaccessible by EUS-guided approach
• AXIOS stent has already been placed into the WON prior to the enrollment
• Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5
• Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
• Patients who cannot tolerate endoscopic procedures
• Pregnant women
• Patients considered inappropriate for inclusion by investigators

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 21 центр

• Department of Gastroenterology, The University of Tokyo Hospital — Bunkyō-Ku
• Department of Gastroenterology, Graduate School of Medicine, Juntendo University — Bunkyō-Ku
• Department of Gastroenterology, Aichi Medical University — Aichi
• Department of Gastroenterology, Graduate School of Medicine, Chiba University — Chiba
• Department of Gastroenterology, Gifu Municipal Hospital — Gifu
• Department of Gastroenterology, Gifu Prefectural General Medical Center — Gifu
• First Department of Internal Medicine, Gifu University Hospital — Gifu
• Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Inte — Hyōgo
• … и ещё 13 центров

Публикации

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25. PMID 23100216
• Saito T, Fujisawa T, Ogura T, Kuwatani M, Ohyama H, Takenaka M, Doi S, Iwata K, Hashimoto S, Kamada H, Iwashita T, Shiomi H, Masuda A, Matsubara S, Hayashi N, Maruta A, Kogure H, Inoue T, Yamada R, Shiratori T, Hamada T, Ueno S, Okuda A, Takahashi S, Sugiura R, Kawakubo K, Takahashi K, Kan M, Omoto S, Yamazaki T, Katsukura N, Okuno M, Hinokuchi M, Namima D, Uemura S, Nakano R, Sakai A, Suda K, Yos PMID 41720198
• Sato T, Saito T, Takenaka M, Iwashita T, Shiomi H, Fujisawa T, Hayashi N, Iwata K, Maruta A, Mukai T, Masuda A, Matsubara S, Hamada T, Inoue T, Ohyama H, Kuwatani M, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Ogura T, Nakahara K, Doi S, Chinen K, Isayama H, Yasuda I, Nakai Y; WONDERFUL study group in Japan, collaborators. WONDER-01: immediate necrosectomy vs. drainage-oriented step-up PMID 37226252

Идентификаторы

NCT: NCT05451901 · 2021005P · jRCT1032220055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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