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SIMULTANEOUS VS SEQUENTIAL DRAINAGE OF MULTIPLE INFECTED PANCREATIC NECROTIC COLLECTIONS IN PATIENTS WITH ACUTE NECROTIZING PANCREATITIS: A RANDOMIZED TRIAL
Date
May 20, 2024
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Background: Minimally invasive step-up approach is the recommended modality of treatment in patients with infected pancreatic necrosis (IPN). Majority of patients with pancreatic collections are having a single IPN, however, some patients with necrotizing pancreatitis have multiple IPNs. In such scenario, whether drainage of all collections simultaneously has better clinical outcome compared to draining collections sequentially as per clinical response has not been explored earlier. We performed a single center, open label, randomized trial to compare sequential drainage vs simultaneous drainage of multiple IPNs in patients with acute necrotizing pancreatitis (ANP).
Methods: All consecutive patients of acute pancreatitis with multiple (>1) confirmed or clinically suspected IPN(size in maximum diameter should be at least 5cm) were screened for inclusion criteria. In simultaneous group(group A), all independent collections were intervened simultaneously using either endoscopic or percutaneous approach depending on location and feasibility. In sequential group (group B), only collection with larger size or gas configuration was intervened using either endoscopic or percutaneous approach depending on location and feasibility. Additional interventions in either group were done as per pre-defined clinical criteria. Primary outcome was the score on Comprehensive Complication Index(CCI) till clinical success. Secondary outcomes were number of interventions required for clinical success, new onset organ failure, major disease/procedure related complications and mortality. End-points were analyzed by intention to treat. (CTRI/2022/07/043878)
Results: 60 patients with multiple IPNs were enrolled(29 patients in group A and 31 in group B). All patients were having an ongoing SIRS (Systemic inflammatory response syndrome) and 66.6%(n=40) patients were having an ongoing organ failure at time of enrollment. Mean CCI was 72.48 ± 28.28 in group A and 64.43 ± 34.91 in group B (p=0.332). Mean number of total interventions (endoscopic, radiological and surgical) was lower in group B(4.55 ± 2.21 vs 3.23 ± 2.14; p=0.022 respectively) compared to group A. Development of new onset organ failure (34.5% vs 38.7%; p=0.734), pancreatic fistula (13.8% vs 9.7%; p=0.65); major bleeding (20.7% vs 6.5%; p=0.11); and requirement of surgical intervention (27.6% vs 22.6%; p=0.655) were equal amongst both groups. Mortality was also equal amongst both the groups (41.3% vs 38.7%; p=0.833).
Conclusion: In patients with multiple large IPNs requiring interventions, initially only larger collection or collection with gas configuration should be intervened along with continuation of the supportive treatment. Sequential drainage tailored according to the clinical response has equivalent clinical outcome with fewer requirement of interventions compared to simultaneous drainage of all collections.
Methods: All consecutive patients of acute pancreatitis with multiple (>1) confirmed or clinically suspected IPN(size in maximum diameter should be at least 5cm) were screened for inclusion criteria. In simultaneous group(group A), all independent collections were intervened simultaneously using either endoscopic or percutaneous approach depending on location and feasibility. In sequential group (group B), only collection with larger size or gas configuration was intervened using either endoscopic or percutaneous approach depending on location and feasibility. Additional interventions in either group were done as per pre-defined clinical criteria. Primary outcome was the score on Comprehensive Complication Index(CCI) till clinical success. Secondary outcomes were number of interventions required for clinical success, new onset organ failure, major disease/procedure related complications and mortality. End-points were analyzed by intention to treat. (CTRI/2022/07/043878)
Results: 60 patients with multiple IPNs were enrolled(29 patients in group A and 31 in group B). All patients were having an ongoing SIRS (Systemic inflammatory response syndrome) and 66.6%(n=40) patients were having an ongoing organ failure at time of enrollment. Mean CCI was 72.48 ± 28.28 in group A and 64.43 ± 34.91 in group B (p=0.332). Mean number of total interventions (endoscopic, radiological and surgical) was lower in group B(4.55 ± 2.21 vs 3.23 ± 2.14; p=0.022 respectively) compared to group A. Development of new onset organ failure (34.5% vs 38.7%; p=0.734), pancreatic fistula (13.8% vs 9.7%; p=0.65); major bleeding (20.7% vs 6.5%; p=0.11); and requirement of surgical intervention (27.6% vs 22.6%; p=0.655) were equal amongst both groups. Mortality was also equal amongst both the groups (41.3% vs 38.7%; p=0.833).
Conclusion: In patients with multiple large IPNs requiring interventions, initially only larger collection or collection with gas configuration should be intervened along with continuation of the supportive treatment. Sequential drainage tailored according to the clinical response has equivalent clinical outcome with fewer requirement of interventions compared to simultaneous drainage of all collections.
