Long-term outcomes of standard versus extended lymphadenectomy in pancreatoduodenectomy for pancreatic ductal adenocarcinoma: A Chinese multi-center prospective randomized controlled trial

Introduction: The value of extended lymphadenectomy in pancreatoduodenectomy (PD) has been dis-cussed by five randomized controlled studies. However, the limitations in the studies made their conclu-sions not sufficiently reliable. Objectives: This multi-center randomized controlled study was designed to clarify the efficacy of extended lymphadenectomy in PD for pancreatic ductal adenocarcinoma (PDAC).Methods: From December 2016 to October 2018, 170 consecutive patients undergoing PD were enrolled and randomized to standard or extended lymphadenectomy for the treatment of PDAC from three high - volume institutions in China. Demographic, pathological characteristics and survival data of these patients were collected and analyzed. No neoadjuvant treatment was performed. The primary endpoint was the 3-year overall survival.Results: For all patients, the 3-year survival rate was 25.88 %. There was no between-group difference in 3-year survival rate (27.16 % vs 24.72 % p = 0.717). The median survival time for the standard group was 18 months, while for the extended group it was 15 months. The demographic and pathological charac-teristics were similar between groups. More positive lymph nodes could be found in the extended group (2.34 & PLUSMN; 3.46 vs 1.41 & PLUSMN; 2.12, p = 0.035), which led to nodule stage migration. All patients received chemotherapy. But patients in extended group were more likely to fail in completion of all-cycles chemotherapy before recurrence (31.46 % vs 17.28 %, p = 0.032). Incomplete chemotherapy before recur-rence, higher N status and abnormal CA125 were independent risk factors for 1-year survival (p < 0.001, 95 % CI 0.076-0.368; p = 0.017, 95 % CI 1.113-3.021; p = 0.021, 95 % CI 1.136-4.960, respectively), which was higher in the standard group (75.31 % vs 58.43 %, p = 0.020).Conclusion: The extended lymphadenectomy in PD did not improve the long-term survival in patients with PDAC. Patients with extended lymphadenectomy had a worse 1-year overall survival. However, the nodule stage migration facilitated by the extended lymphadenectomy contributed to the precise tumor staging.& COPY; 2022 The Authors. Published by Elsevier B.V. on behalf of Cairo University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Automated summary

This multicenter randomized controlled study found that extended lymphadenectomy during pancreatoduodenectomy did not improve long-term survival in patients with pancreatic ductal adenocarcinoma (PDAC). However, the stage migration caused by extended lymphadenectomy contributed to precise tumor staging.