Mostafa Adel T Mahmoud, Islam Mohamed, Alshayma Alalawneh, EzzElDien A Ibrahim, Omar Alkasabrah, Abdelrahman Awad, Mohamed Abuelazm, Mohamed Elnaggar, Ismail Elkhattib
Early and late DEN show comparable efficacy and safety. Early DEN may reduce the need for adjunctive percutaneous drainage. However, the low certainty of evidence necessitates further high-quality RCTs to confirm these safety and efficiency findings.
BACKGROUND: The optimal timing of direct endoscopic necrosectomy (DEN) for pancreatic walled-off necrosis (WON) remains uncertain, with practice varying from early intervention to a delayed approach. This systematic review and meta-analysis aims to compare the clinical efficacy and safety of early versus late DEN.
METHODS: We systematically searched Cochrane, PubMed, Scopus, and Web of Science until October 28, 2025, for studies comparing early and late DEN. The primary outcomes were clinical success, technical success, the number of necrosectomy sessions, the need for percutaneous drainage, mortality, and procedure-related adverse events. Pooled estimates were calculated using random- or fixed-effects models and reported as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI). Trial sequential analysis (TSA) was performed, and the certainty of evidence was evaluated.
PROSPERO ID: CRD420251176766.
RESULTS: Eight studies were included, comprising three randomized controlled trials (RCTs) and five cohort studies, involving 745 patients. No significant differences were observed in clinical success (RR 1.04, 95% CI 0.99 to 1.09), technical success (RR 1.01, 95% CI 0.98 to 1.04), number of necrosectomy sessions (MD 0.35, 95% CI -0.50 to 1.19), mortality (RR 1.17, 95% CI 0.61 to 2.27), or overall adverse events (RR 0.91, 95% CI 0.68 to 1.22). TSA indicated firm evidence of no difference for clinical and technical success. In RCTs alone, early DEN was associated with a reduced need for percutaneous drainage (RR 0.44, 0.20 to 0.96). The certainty of evidence was rated as very low for most outcomes.
CONCLUSIONS: Early and late DEN show comparable efficacy and safety. Early DEN may reduce the need for adjunctive percutaneous drainage. However, the low certainty of evidence necessitates further high-quality RCTs to confirm these safety and efficiency findings.