Endoscopic therapy in patients with pancreas divisum and acute pancreatitis: a prospective, randomized, controlled clinical trial

Endoscopic endoprosthesis (stent) placement across the minor papilla has been shown to be beneficial in reducing abdominal pain and episodes of pancreatitis in a small group of patients with pancreas divisum and acute recurrent pancreatitis. In a randomized, controlled clinical trial, 19 patients with pancreas divisum and at least 2 documented episodes of pancreatitis were randomized to either dorsal duct stent placement (10 patients—5 women and 5 men) or controls (9 patients— 6 women and 3 men). All other causes of pancreatitis were excluded. Patients were followed at 4-month intervals for evaluation and/or stent exchange during a 1-year period. The following criteria were evaluated during follow-up: number of hospitalizations or emergency room visits, the number of documented episodes of pancreatitis, and gradation of the patient's overall general feeling based on a visual analog scale. Mean follow-up times in the stent and control groups were 28.6 and 31.5 months, respectively (p > 0.05, NS). No patients in the stent group required hospitalization or emergency room visits for abdominal pain only during and following the treatment period. However, in the control group there were five hospitalizations and two emergency room visits for abdominal pain during a similar period (p < 0.05). Pancreatitis was documented with an elevated amylase twice the normal range, one time in the stent group and seven times in the control group (p < 0.05). Based on visual analog scale determinations, 9 of 10 (90%) patients in the stent group reported ≥50% symptomatic improvement compared with 1 of 9 (11%) patients in the control group (p < 0.05). Four of nine patients in the control group did poorly and subsequently had stent placement. These patients did not require hospitalization or suffer any further episodes of pancreatitis for a period ranging from 6 to 53 months. Dorsal pancreatic duct stent placement across the minor papilla in patients with pancreas divisum and acute recurrent pancreatitis resulted in significant objective and subjective clinical improvement compared with controls in a short-term follow-up study.