Early On-demand Intervention Versus STandard Management among Acute NecrotIzing Pancreatitis Patients CoMplicated by PersIsteNt OrGan Failure: a Multi-center Randomized Trial

 

Version: V2.0
Study design:a multi-center randomized trial
Estimated recruitment: 520
Overall trial start date: 01/03/2019
Overall trial end date: 01/03/2022
Recruitment start date: 13/03/2019
Recruitment start date: 13/03/2021

Summary

The classification of acute pancreatitis and its complications were comprehensively redefined in the Revised Atlanta Classification(RAC) published in 2012. The severity of acute pancreatitis was classified majorly based on the occurrence and duration of “organ failure”. A novel local complication called acute necrotic collection(ANC) was proposed in this version, which denotes “a collection containing variable amounts of both fluid and necrosis associated with necrotizing pancreatitis” according to the RAC guidelines
in patients with POF, namely, the most severe type of AP patients, ANC is very common and it is controversial that if early invasive intervention before confirming infection is beneficial in this entity. Considering the pathophysiology of SAP, despite the sterile nature, ANC always contain numerous enzymes and inflammatory mediators, which play important roles in the development of POF and SIRS. Moreover, previous studies showed that the longer organ failure persists, the higher the mortality and morbidity are. POF is also reported to be associated with the development of infected pancreatic necrosis.
Based on the abovementioned evidence, early intervention is suggested for ANC in some previous studies, but the optimal timing remains unknown. Moreover, in patients with deteriorated organ function, early signs of infection, no matter clinical or biochemical, could be covert, so that the optimal timing might be missed due to long-term search for evidence of infection. Taken together, it is controversial whether delayed strategy in patients showing clinical deterioration before clear signs or evidence of infection is beneficial or even worsen the outcomes.
Therefore, we conducted a randomized, controlled, multi-center study to compare the effect of immediate intervention and standard treatment (delayed strategy) in patients with deteriorated organ failure during the observation period (from randomization to hospital discharge or death).
Clinical interventional study performed in 5 tertiary teaching hospitals. We projected estimated sample size of 116 participants. Patients are randomized to early percutaneous intervention or to standard treatment (1:1 ratio within each participating center and sample size of each center was predefined based on its volume) with a web-based randomization module (Interactive Web-Respond System (IWRS).

Attachments

Pilot study: The timing and indications for drainage in acute pancreatitis patients with acute necrotic collections and persistent organ failure: a pilot randomized controlled trial comparing early on-demand drainage and standard management