Postponed or Immediate Drainage of Infected Necrotizing Pancreatitis (POINTER): A Multicenter Randomized Trial

Purpose: Infected necrotizing pancreatitis is a potentially lethal disease treated by a step-up approach, with catheter drainage as first step. Patient outcome may be improved by early catheter drainage, but supporting evidence is limited. Methods: We conducted a multicenter randomized trial in 22 Dutch hospitals, to determine whether immediate catheter drainage is superior to postponed catheter drainage in patients with infected necrotizing pancreatitis. Immediate catheter drainage included treatment with antibiotics and catheter drainage within 24 hours after patients were diagnosed with infected necrosis. Postponed catheter drainage included treatment with antibiotics and supportive treatment, aimed to postpone the drainage procedure until necrosis became walled-off. The primary end point was the Comprehensive Complication Index (CCI), combining all complications during 6 months of follow-up. Results: In total, 104 patients were randomly assigned to immediate catheter drainage (55 patients) or postponed catheter drainage (49 patients). The median CCI was 56.46 (IQR 34.46-80.47) in the immediate drainage group and 48.22 (IQR 39.05-83.29) in the postponed drainage group (P=0.97). No significant difference between the immediate and postponed drainage group was observed in the rate of new-onset organ failure (25% and 22%; RR 1.13, 95%CI 0.57-2.26, P=0.82) and death (13% and 10%; RR 1.25, 95%CI 0.42-3.68, P=0.77). The median number of interventions for infected necrosis was 4 (IQR 2-6) and 1 (IQR 0-5) (P<0.001). The length of intensive care stay was equal in both groups (median 0 days [IQR 0-8] vs. 0 days [IQR 0-8], P=0.76) and total hospital did not differ significantly (median 48 days [36-83] vs. 35 days [21-66], P=0.07). In the postponed drainage group, 19 patients (39%) were successfully treated with antibiotics alone, with 17 surviving patients. Conclusions: Immediate catheter drainage in patients with infected necrotizing pancreatitis is not superior to postponed catheter drainage in reducing CCI. With a postponed catheter drainage strategy including antibiotic treatment, more than one-third of patients may be treated conservatively.