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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

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Qu, Cheng, Zhang, He, Chen, Tao ORCID: https://orcid.org/0000-0002-5489-6450, Zhu, Yin, Feng, Quanxing, Guo, Feng, Liu, Zhiyong, Li, Gang, Ye, Bo, Zhou, Jing, Cao, Longxiang, Ke, Lu, Tong, Zhi-hiu, Windsor, John and Li, Wei-qin (2020) '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'. Pancreatology. (In Press)

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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.

Item Type: Article
Subjects: QZ Pathology > Manifestations of Disease > QZ 140 General manifestations of disease
WI Digestive System > WI 20 Research (General)
WK Endocrine System > WK 100 Endocrine glands (General)
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI): https://doi.org/10.1016/j.pan.2020.08.012
Related URLs:
Depositing User: Christine Bradbury
Date Deposited: 14 Sep 2020 15:45
Last Modified: 14 Sep 2020 15:45
URI: https://archive.lstmed.ac.uk/id/eprint/15567

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