Journal of gastroenterology and hepatology · 2025
Nonsuperiority of Simultaneous Compared With Sequential Interventions in Infected Necrotic Collections at Multiple Sites in Acute Necrotizing Pancreatitis: A Randomized Trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Siddharda Bikkina Venkat, Shah Jimil, Gupta Pankaj, Bhujade Harish, Ancil Sanish, Jearth Vaneet, Singh Anupam K, Mandavdhare Harshal S, Sharma Vishal, Sakaray Yashwant Raj, Singh Harjeet, Gupta Rajesh, Gkolfakis Paraskevas, Arvanitakis Marianna, Rana Surinder, Dutta Usha
Аннотация
BACKGROUND: Patients with infected pancreatic necrosis (IPN) may need multiple interventions when the necrotic collection is multifocal. However, the efficacy of simultaneous interventions has not been compared with sequential interventions in this group of patients.
METHODS: We performed a single-center, open-label, superiority, randomized trial at a tertiary-level hospital to compare simultaneous versus sequential intervention of infected necrotic collections involving at least two anatomical sites. In the simultaneous group (Group A), all sites were drained simultaneously. In the sequential group (Group B), only the largest site or the site with gas foci was drained initially. Additional interventions in either group were done based on predefined clinical criteria. The primary outcome was the Comprehensive Complication Index (CCI) until clinical success or death. Secondary outcomes were the number of interventions, major disease-related complications, and mortality. An intention-to-treat analysis was performed.
RESULTS: We assessed 253 patients for eligibility, and 60 patients were enrolled (29 in Group A and 31 in Group B). The mean age was 36.9 ± 13.4 years. The mean CCI was similar among both groups (72.5 ± 28.3 vs. 64.4 ± 34.9; 95% CI, -24.59 to 8.39). The number of interventions in Group B was significantly lower (4.17 ± 2.00 vs. 2.97 ± 1.94; 95% CI, -0.18 to -2.22). Development of new-onset organ failure (34.5% vs. 38.7%), need for surgical intervention (27.5% vs. 22.5%), and mortality (41.3% vs. 38.7%) were not significantly different between the groups.
CONCLUSION: A simultaneous intervention approach aimed at draining multiple sites is not superior to a sequential intervention approach guided by clinical outcomes in patients with IPN involving multiple sites.
TRIAL REGISTRATION: CTRI identifier: CTRI/2022/07/04387.
METHODS: We performed a single-center, open-label, superiority, randomized trial at a tertiary-level hospital to compare simultaneous versus sequential intervention of infected necrotic collections involving at least two anatomical sites. In the simultaneous group (Group A), all sites were drained simultaneously. In the sequential group (Group B), only the largest site or the site with gas foci was drained initially. Additional interventions in either group were done based on predefined clinical criteria. The primary outcome was the Comprehensive Complication Index (CCI) until clinical success or death. Secondary outcomes were the number of interventions, major disease-related complications, and mortality. An intention-to-treat analysis was performed.
RESULTS: We assessed 253 patients for eligibility, and 60 patients were enrolled (29 in Group A and 31 in Group B). The mean age was 36.9 ± 13.4 years. The mean CCI was similar among both groups (72.5 ± 28.3 vs. 64.4 ± 34.9; 95% CI, -24.59 to 8.39). The number of interventions in Group B was significantly lower (4.17 ± 2.00 vs. 2.97 ± 1.94; 95% CI, -0.18 to -2.22). Development of new-onset organ failure (34.5% vs. 38.7%), need for surgical intervention (27.5% vs. 22.5%), and mortality (41.3% vs. 38.7%) were not significantly different between the groups.
CONCLUSION: A simultaneous intervention approach aimed at draining multiple sites is not superior to a sequential intervention approach guided by clinical outcomes in patients with IPN involving multiple sites.
TRIAL REGISTRATION: CTRI identifier: CTRI/2022/07/04387.