Accelerated Vs Step-Up Endoscopic Treatment for Large Pancreatic Walled-Off Necrosis: A Single-Center Randomized Trial (Accelerate Trial)

Aims Pancreatic walled-off necrosis (WON) is a complication of acute necrotizing pancreatitis often resulting in prolonged hospitalization. While the endoscopic step-up approach with endoscopic ultrasound guided transmural drainage followed by, if necessary, endoscopic necrosectomy, has become gold standard for treating WON, a recent study suggests that performing necrosectomy immediately after drainage yields favorable outcomes. We hypothesize that an accelerated treatment algorithm for patients with large WON could reduce hospital length of stay (LOS) and decrease the incidence of major complications. An interim analysis was performed after treatment of 25 patients according to protocol.

Methods This single-center, randomized trial enrolled patients with WON>15 cm in diameter from November 2022 to April 2024. Patients were randomized to either conventional step-up or an accelerated treatment algorithm. Both groups underwent transgastric drainage. In the accelerated group, necrosectomy was performed at the index procedure and repeated as needed until the WON cavity was cleared of necrotic tissue. In the step-up group, subsequent endoscopic necrosectomy or additional drainage was only performed if no clinical improvement was observed. The primary endpoint was a composite of death, major complications (as defined by the TENSION protocol), and LOS exceeding 58 days from the index procedure. Secondary outcomes included mortality, major complications, and LOS.

Results A total of 25 patients were included in this interim analysis: 12 in the accelerated group and 13 in the step-up group. As advised by the review board, the trial was discontinued at the interim analysis due to differences in safety outcomes observed between the groups. The groups were comparable in terms of gender distribution, age, Charlson Comorbidity score, etiology of acute pancreatitis, indication for treatment, and WON size, with an overall median diameter of 21.8 cm [interquartile range (IQR) 20.1-26.6], defined as the largest measured diameter of the WON on cross-sectional imaging. The primary composite outcome occurred in 1 of 12 patients (8.3%) in the accelerated group and in 8 of 13 patients (61.5%) in the step-up group (odds ratio (OR) 0.057; p=0.011). One patient in the step-up group died because of hemorrhage 14 days after index procedure. Major complications were significantly lower in the accelerated group (0.0% vs. 46.2%; p=0.015). In the step-up group, the first encountered major complication occurred a median of 36 days [IQR 19-42] after initial drainage. The median LOS was significantly shorter in the accelerated group (32.5 days [IQR 17.5-38.2] vs. 68.5 days [IQR 35.5-97.8], p=0.039) [1] [2] [3] [4].

Conclusions An accelerated treatment algorithm seems to reduce both the rate of major complications and the LOS compared to a conventional step-up approach, suggesting that a more aggressive treatment approach is preferable in patients with large symptomatic WON.

Publication History

Article published online:
27 March 2025

• References

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