title: A prospective randomized trial comparing standard pancreatoduodenectomy with pancreatoduodenectomy with extended lymphadenectomy in resectable pancreatic head adenocarcinoma.
abstract: BACKGROUND
  To compare operative morbidity, mortality, quality of life, and survival after pancreatoduodenectomy (PD) versus pancreatoduodenectomy with extended lymphadenectomy (PD/ELND) in patients with resectable pancreatic cancer.
  
  
  METHODS
  From May 1997 to July 2003 there were 132 patients with biopsy examination-proven or suspected adenocarcinoma of the pancreatic head who agreed to participate in a single-institution, prospective, randomized trial. If resectable at operation, patients then were randomized to standard PD (40 patients) or PD/ELND (39 patients). Quality of life was assessed by using the Functional Assessment of Response to Cancer Therapy specific to the pancreas. Morbidity, mortality, and survival were analyzed.
  
  
  RESULTS
  Demographics and pathologic characteristics for both groups were similar. When comparing PD/ELND with standard PD, the median operating time was greater for the PD/ELND group (7.6 h vs 6.2 h, P < .01), blood transfusion more likely (44% vs 22%, P < .05), and the median number of lymph nodes resected was greater (36 vs 15 nodes, P < .01). Morbidity and mortality rates were comparable. Median durations of stay were 11 and 10.5 days (P = NS), respectively. There were no significant differences in 1-year (71% vs 82%), 3-year (25% vs 41%), 5-year (16.5% vs 16.4%), and median (19 vs 26 mo) survival (P = .32). At 4 months postoperatively, diarrhea, body appearance, and bowel control scored lower on the Functional Assessment of Response to Cancer Therapy specific to the pancreas after PD/ELND (P < .05).
  
  
  CONCLUSIONS
  Although a much larger study would have more power to compare statistically the survival between groups, both the decrement in quality of life and similar studies showing no survival difference make PD/ELND unattractive for further prospective investigation.
authors.affiliation: Mayo Clinic, Rochester, Minnesota 55905, USA. mfarnell@mayo.edu
authors.forename: Michael B
authors.initials: MB
authors.lastname: Farnell
authors.forename: Randall K
authors.initials: RK
authors.lastname: Pearson
authors.forename: Michael G
authors.initials: MG
authors.lastname: Sarr
authors.forename: Eugene P
authors.initials: EP
authors.lastname: DiMagno
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Burgart
authors.forename: Tamela R
authors.initials: TR
authors.lastname: Dahl
authors.forename: Nathan
authors.initials: N
authors.lastname: Foster
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sargent
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003967:Diarrhea / Q000209:etiology / Q000503:physiopathology; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D016577:Pancreaticoduodenectomy; D011183:Postoperative Complications; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis