Laparoscopic vs Open pancreaticoduodenectomy: Preliminary results from a randomized controlled trial (PADULAP TRIAL)

Abstract

Background: Good results of laparoscopic pancreaticoduodenectomy (LPD) have been reported in selected patients, but no RCT’s have been published. We present the interim analysis of RCT of laparoscopic vs open pancreaticoduodenectomy (OPD) according to intention to treat PADULAP trial CCT-NAPN-23575. Methods: The PADULAP trial was designed for patients undergoing pancreaticoduodenectomy (PD) for any diagnosis. Main endpoints were length of stay and postoperative results. Of 51 cases eligible, 5 were excluded, 24 underwent LPD and 22 OPD. Results: No differences were found between groups at inclusion. Conversion rate was 32%. Operative time was significantly longer in LPD (496 vs 353 min, p<0.01). In-hospital and 90-days mortality was none in the LPD group, and 9% and 13.6%, respectively in OPD (p=ns). Clinically relevant (grades B and C) pancreatic postoperative fistula (POPF) was 8.3% and 27.3% for LPD and OPD (p=0.01). Reoperation rate was 4.1% in LPD and 18%, respectively (p=0.21). Although postoperative De Oliveira-Clavien complications grades III-IV were 8.3% and 27.3% for LPD and OPD groups, respectively, no significant differences were observed (p=0.09). Harvested lymph nodes were 16 and 17 for LPD and OPD (p=0.67). Length of stay was 14 and 16 days for LPD and OPD groups (p=0.25). Conclusion: Preliminary results show that LPD is safe and feasible, although high conversion rate when done in non-selected patients. No differences in clinical outcomes were observed between approaches.