Prospective randomized controlled trial comparing laparoscopic versus open pancreaticoduodenectomy for malignant periampullary and pancreatic head lesions

Abstract

Background: Current literature supports the use of laparoscopic pancreaticoduodenectomy (LPD) as an alternative to open pancreaticoduodenectomy (OPD) for pancreatobiliary malignancies. Studies done so far are case series and matched comparisons; a randomized trial analysing two has not been reported. Materials and method: Trial included 64 patients with resectable peri-ampullary or pancreatic head cancer, randomized by computer generated random numbers into either LPD or OPD group during September 2013 to August 2015. Sample size was 32 in each arm, assuming power of study 80% & type I error of 0.05. Primary outcome measure was hospital stay, secondary outcome measures were blood loss, operation time, pathological radicality and complication rate. Results: Mean operative time 260.2 min (±11.10) in OPD, 359.4 min (±13.84) in LPD (p = 0.0308). Mean blood loss 300.6 ml (±46.56) in OPD, 249.8 ml (±22.33) in LPD (p<0.001). Conversion rate of 3.1%. The median length of stay in OPD was 12 days (6–30), LPD of 8 days (5–52) (p = 0.0001). Pancreatic fistula 18.75% in OPD; 15.60% in LPD (p = 0.314), overall complications (Clavien Dindo) 31.25% in OPD; 25% in LPD (p = 0.755) and 3.1% mortality in each arm. Mean nodes retrieved in OPD 17.00 (±1.47), LPD 18.97 (±1.0) with 0.95 CI, p = 0.059. Conclusion: This study establishes safety of LPD in terms of short term outcomes, complications, mortality and oncological radicality to that of OPD, has benefits of shorter hospital stay, reduced blood loss and lesser wound complications. Comparisons in terms of disease free survival and long term survival remains to be seen (NCT02081131).