'Posterior (SMA-first) Approach' Versus 'Standard Approach' in Terms of Resection Margin and Long-Term Survival After Pancreaticoduodenectomy for Periampullary and Pancreatic Carcinoma: A Randomized Trial.

INTRODUCTION: SMA-first-approach in pancreaticooduodenectomy (PD) was found to be associated with better oncological outcomes as compared to the standard approach both in our pilot study and a few retrospective studies. Hence, we performed a randomized controlled trial to compare these two approaches in terms of resection margins, lymph node-retrieval, and long-term survival. METHODS: Between January 2014 to December 2018, all the consecutive patients undergoing PD for periampullary cancer at the Department of Gastrointestinal Surgery, AIIMS, New Delhi were assessed for randomization. Primary outcomes were R0 resection rate and number of lymph nodes retrieved. The secondary outcomes were operating time, blood loss, postoperative complications, recurrence free and overall survival. RESULTS: Of 299 patients assessed, 203 were randomized and 183 analyzed (20: excluded after randomization, 90: patients-SMA, 93: patients-classical). The median age of the study population was 56 (14-78) years, with predominantly male (138, 68%) and with periampullary tumors (89%). The demographic profile, preoperative clinical and laboratory parameters were comparable. The blood loss was significantly higher in SMA first group (675 vs 600 ml, p = 0.02), however the operating time and the need for blood transfusion were comparable in both groups. ISGPS Grade B/C pancreatojejunostomy leak (20 vs 24.7%, p = 0.68), post-pancreatectomy hemorrhage (8.8 vs 14%, p = 0.38), delayed gastric emptying (37.8 vs 40.9%, p = 0.67) and Clavien-Dindo grade ≥III complications(27.7 vs 31.2, p = 0.85) were similar in both the groups. The R0 resection rates (82.2 vs 78.5%, p = 0.53) and total lymphnodes retrieved (18 vs 17, p = 0.63) were similar between the two groups. Both groups were comparable in terms of median recurrence free (48 vs 44 months, p = 0.85) and overall survival (53 vs 51 months, p = 0.69). CONCLUSIONS: 'Posterior (SMA-first) approach' and 'Standard approach' for pancreatoduodenectomy for periampullary cancer yielded equivalent results in terms of R0 resection rate, number of lymph nodes retrieved, recurrence-free and overall-survival.