Early on‐demand drainage or standard management for acute pancreatitis patients with acute necrotic collections and persistent organ failure: A pilot randomized controlled trial

Abstract

Background/Purpose The current standard care for acute pancreatitis with acute necrotic collections (ANC) is to postpone invasive intervention for 4 weeks when indicated. However, in patients with persistent organ failure (POF), this delayed approach may prolong organ failure. In this study, we aimed to assess the feasibility and safety of earlier drainage for acute pancreatitis patients with ANC and POF. Methods A single‐center, randomized controlled trial was conducted. Eligible patients were randomly assigned to either the early on‐demand (EOD) group or the standard management (SM) group. Within 21 days of randomization, early drainage was triggered by unremitted or worsening organ failure in the EOD group. The primary endpoint was a composite of major complications/death during 90‐days follow‐up. Results Thirty patients were randomized. Within 21 days of randomization, eight of the 15 patients (53%) in the EOD group underwent percutaneous drainage compared to four of the 15 patients (27%) in the SM group (P = 0.26). The primary outcome occurred in three of the 15 (20%) patients in the EOD group and seven of the 15(46.7%) in the controls (P = 0.25, relative risk 0.43, 95%CI 0.14 to 1.35). Conclusions Although the EOD approach did not result in significant differences between groups, the primary outcome assessed in this trial demonstrated the potential for clinical benefits favoring early drainage.

The optimal timing and intervention to reduce mortality for necrotizing pancreatitis: a systematic review and network meta-analysis

“…We did not identify any non-English articles that met our inclusion criteria. Finally, 10 RCTs were eligible for quality assessment and quantitative synthesis [ 39 – 48 ]. A PRISMA flowchart is presented in Fig.…”

“…The 10 included studies were published from 1984 to 2021, with their respective studies starting from 1982 to 2019 across 6 countries [ 39 – 48 ] (Table 1 ). Ten studies [ 39 – 48 ] were designed as two-arm randomized controlled trials.…”

“…The 10 included studies were published from 1984 to 2021, with their respective studies starting from 1982 to 2019 across 6 countries [ 39 – 48 ] (Table 1 ). Ten studies [ 39 – 48 ] were designed as two-arm randomized controlled trials. A total of 570 participants with necrotizing pancreatitis were randomly assigned to one of the 8 interventions: 4 studies [ 39 , 40 , 47 , 48 ] for early drainage (ED), 2 studies [ 47 , 48 ] for delayed drainage (DD), 5 studies [ 39 – 42 , 46 ] for early surgery (ES), 1 study [ 46 ] for early endoscopic step-up approach (EEU), 1 study [ 45 ] for delayed endoscopic step-up approach (DEU), 3 studies [ 42 , 43 , 45 ] for delayed surgical step-up approach (DSU), 1 study [ 44 ] for delayed endoscopic debridement (DE) and 3 studies [ 41 , 43 , 44 ] for delayed surgery (DS).…”

“…The proportion of males in these studies ranged from 58 to 90.9%, and the mean age of patients ranged from 35.7 to 63 years. The etiology of necrotizing pancreatitis was reported in 7 studies [ 41 , 43 – 48 ], and biliary pancreatitis was the most commonly identified etiology (53.2%, 235/442). The detailed baseline characteristics are shown in Additional file 1 : Appendix S3.…”

Drainage of pancreatic fluid collections in acute pancreatitis: A comprehensive overview

“…A single arm retrospective study evaluated the role of early PCD (< 21 d), with a mean time of intervention of 14.3 ± 2.4 d, for multiple indications, which showed an overall survival rate of 73.1%. More than 50% of the patients survived on PCD alone, whereas 19.2% required additional necrosectomy[ 23 ].…”