STANDARD VERSUS EXTENDED LYMPHADENECTOMY ASSOCIATED WITH PANCREATICODUODENECTOMY IN THE SURGICAL-TREATMENT OF ADENOCARCINOMA OF THE HEAD OFTHE PANCREAS - A MULTICENTER, PROSPECTIVE, RANDOMIZED STUDY

Objective The study was conducted to determine whether the performance of an extended lymphadenectomy and retroperitoneal soft-tissue cleara nce in association with a pancreatoduodenal resection improves the lon g-term survival of patients with a potentially curable adenocarcinoma of the head of the pancreas. Summary Background Data The usefulness of performing an extended lymphadenectomy and retroperitoneal soft-tissu e clearance in conjunction with a pancreatoduodenal resection In the t reatment of ductal adenocarcinoma of the head of the pancreas is still unknown. Published studies suggest a benefit for the procedure in ter ms of better long-term survival rates; however, these studies were ret rospective or did not prospectively evaluate large series of patients. Materials and Methods Eighty-one patients undergoing a pancreatoduode nal resection for a potentially curable ductal adenocarcinoma of the h ead of the pancreas were randomized to a standard (n = 40) or extended (n = 41) lymphadenectomy and retroperitoneal soft-tissue clearance in a prospective, multicentric study. The standard lymphadenectomy inclu ded removal of the anterior and posterior pancreatoduodenal, pyloric, and biliary duct, superior and inferior pancreatic head, and body lymp h node stations. In addition to the above, the extended lymph adenecto my included removal of lymph nodes from the hepatic hilum and along th e aorta from the diaphragmatic hiatus to the inferior mesenteric arter y and laterally to both renal hila, with circumferential clearance of the origin of the celiac trunk and superior mesenteric artery. Patient s did not receive any postoperative adjuvant therapy. Results Demograp hic (age, gender) and histopathologic (tumor size, stage, differentiat ion, oncologic clearance) characteristics were similar in the two pati ent groups. Performance of the extended lymphadenectomy added time to the procedure, although the difference did not reach statistical signi ficance (397 +/- 50 minutes vs. 372 +/- 50 minutes, p > 0.05): Transfu sion requirements, postoperative morbidity and mortality rates, and ov erall survival did not differ between the two groups. When subgroups o f patients were analyzed, using an a posteriori analysis that was not planned at the time of study design, there was a significantly (p < 0. 05) longer survival rate in node positive patients after an extended r ather than a standard lymphadenectomy. The survival curve of node posi tive patients after an extended lymphadenectomy could be superimposed onto the curves of node negative patients. Survival curves in node neg ative patients did not differ according to the magnitude of the lympha denectomy. Multivariate analysis of all patients showed that long-term survival was affected by tumor differentiation (weil vs. moderately v s, poorly differentiated, p > 0.001), diameter (less than or equal to 2.0 cm. vs. > 2.0 cm, p < 0.01), lymph node metastasis (absent vs, pre sent, P <0.01) and need for 4 or more units of transfused blood (< 4 v s. greater than or equal to 4, p <0.01). Conclusions The addition of a n extended lymphadenectomy and retroperitoneal soft-tissue clearance t o a pancreatoduodenal resection does not significantly increase morbid ity and mortality rates. Although the overall survival rate does not d iffer in the two groups, there appears to be a trend toward longer sur vival in node positive patients treated with an extended rather than a standard lymphadenectomy.