Early on-demand drainage versus standard management among acute necrotizing pancreatitis patients complicated by persistent organ failure: The protocol for an open-label multi-center randomized controlled trial.

Abstract

INTRODUCTION/AIM:

Pancreatic necrosis occurs in a quarter of patients with acute pancreatitis, many of whom form an acute necrotic collection (ANC). The current standard treatment is to defer percutaneous catheter drainage (PCD) until the latter becomes "walled off," which takes approximately four weeks. The majority of patients that develop persistent organ failure (POF), the primary determinant of mortality, do so within four weeks. To defer PCD until after four weeks may result in a worse outcome because of a missed opportunity to treat early infection and thereby reduce the severity and/or duration of POF. This study is aimed to compare the clinical outcome of the current standard approach with early on-demand PCD in acute necrotizing pancreatitis (ANP) patients with ANC and POF.

METHODS/DESIGN:

This is an open-label, multi-center, parallel, randomized, controlled trial. All patients with ANP who develop POF during the first week of onset will be screened for eligibility. In total, 120 study subjects will be randomized to either early on-demand PCD or standard care. Patients assigned to the former will receive PCD when they show signs of decompensation like new-onset OF, aggravation of pre-existent OF, and persistent OF for more than a week. The primary composite endpoint is major complication and/or death. Patients will be followed until discharge or death with an additional follow-up 90 days after randomization.

DISCUSSION:

This study challenges the standard 4-week delay before PCD and will answer the question whether early on-demand PCD is associated with a lower incidence of major complications and/or death.

• Authors: Cheng Qu, He Zhang, Tao Chen, Yin Zhu, Quanxing Feng, Feng Guo, Zhiyong Liu, Longxiang Cao, Jie Yang, Gang Li, Bo Ye, Jing Zhou, Lu Ke, Zhihui Tong, John Windsor, Weiqin Li, Chinese Acute Pancreatitis Clinical Trials Group(CAPCTG)
• Journal: Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] (Pancreatology) Vol. 20 Issue 7 Pg. 1268-1274 (Oct 2020) ISSN: 1424-3911 [Electronic] Switzerland
• PMID: 32868182 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2020 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Topics

• Adolescent
• Adult
• Aged
• Catheterization
• Drainage (adverse effects, methods)
• Endpoint Determination
• Female
• Humans
• Male
• Middle Aged
• Monitoring, Physiologic
• Multiple Organ Failure (etiology, therapy)
• Pancreatitis, Acute Necrotizing (complications, mortality, therapy)
• Treatment Outcome
• Young Adult