Early surgery versus current step-up practice for chronic pancreatitis: a multicenter randomized controlled trial

Abstract

Background: Surgical intervention for patients with chronic pancreatitis is currently used as last resort treatment when both medical and endoscopic treatment have failed. We conducted a randomized controlled trial to compare early surgery with the current step-up approach. Methods: We included patients with obstructive chronic pancreatitis and severe pain, who recently started using opioids. Patients with strong opioids for >2 months or weak opioids for >6 months were excluded. Patients were randomized to early surgery (i.e. within 6 weeks) or to the step-up approach (medical treatment, endoscopy if needed, surgery if needed). Primary endpoint was the mean Izbicki pain score. Results: Eighty-eight patients were randomized, 44 to early surgery (41 underwent surgery) and 44 to the step-up approach. Patients in the early surgery group had a lower Izbicki pain score during follow-up compared to patients in the step-up approach (35 vs. 48, P= 0.018). Pain relief during follow-up was achieved in 54% of patients in early surgery and in 33% of patients in the step-up approach (P< 0.001). Fewer interventions were performed in the early surgery group (median 1 vs. 3, P< 0.001). Complications, mortality (0%), hospital admissions, pancreatic function and quality of life were comparable among groups. Conclusions: The preferred treatment strategy for patients with chronic pancreatitis and a dilated pancreatic duct is early surgery within the first months of opioid use, because this provides better pain control with less interventions than the current step-up approach.