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

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.