Comparison of long-term clinical outcomes of external and internal pancreatic stents in pancreaticoduodenectomy: randomized controlled study

Abstract Background To determine the most appropriate pancreatic drainage method, by investigating differences in 12-month clinical outcomes in patients implanted with external and internal pancreatic stents as an extension to a previous study on short-term outcome. Methods This prospective randomized controlled trial enrolled 213 patients who underwent pancreaticoduodenectomy with duct to mucosa pancreaticojejunostomy between August 2010 and January 2014 (NCT01023594). Of the 185 patients followed-up for 12 months, 97 underwent external and 88 underwent internal stenting. Their long-term clinical outcomes were compared. Results Overall late complication rates were similar in the external and internal stent groups ( P  = 0.621). The percentage of patients with >50% atrophy of the remnant pancreatic volume after 12 months was similar in both groups ( P  = 0.580). Factors associated with pancreatic exocrine or endocrine function, including stool elastase level ( P  = 0.571) and rate of new-onset diabetes ( P  = 0.179), were also comparable. There were no significant between-group differences in quality of life, as evaluated by the EORTC QLQ-C30 and QLQ PAN26 questionnaires. Conclusion External and internal stents showed comparable long-term, as well as short-term clinical outcomes, including late complication rates, preservation of pancreatic duct diameters, pancreatic volume changes with functional derangements, and quality of life after surgery.