Elsevier

Surgery

Volume 138, Issue 4, October 2005, Pages 618-630
Surgery

Central Surgical Association
A prospective randomized trial comparing standard pancreatoduodenectomy with pancreatoduodenectomy with extended lymphadenectomy in resectable pancreatic head adenocarcinoma

https://doi.org/10.1016/j.surg.2005.06.044Get rights and content

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.

Section snippets

Materials and methods

This study was approved by the Mayo Foundation Institutional Review Board. Patients were recruited into the trial before operation if the preoperative clinical and radiologic diagnoses were consistent with localized pancreatic head adenocarcinoma. Randomization was performed intraoperatively at the time of exploration after the surgeon had determined that metastatic disease was absent and that the tumor was resectable locally. Tissue confirmation was not required before randomization. Patients

Results

Patients were enrolled in the trial from May 1997 to July 2003. A total of 132 patients signed the consent form to participate in the study, 80 patients were deemed resectable at exploration and thus randomized with 79 patients eligible for analysis. There were 40 patients in the standard pancreatoduodenectomy (PD) group and 39 patients in the pancreatoduodenectomy plus extended lymph node dissection (PD/ELND) group. Demographic and intraoperative factors for the 2 groups were comparable (Table

Discussion

This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality. Further, this trial was designed to assess changes in quality of life using recognized validated instruments administered preoperatively and postoperatively. A total of 100 patients were to be enrolled in the trial based on our prespecified power calculation but the

References (28)

  • O. Ishikawa et al.

    Practical usefulness of lymphatic and connective tissue clearance for the carcinoma of the pancreas head

    Ann Surg

    (1988)
  • T.T. Manabe et al.

    Radical pancreatectomy for ductal cell carcinoma of the head of the pancreas

    Cancer

    (1989)
  • R. Tsuchiya et al.

    Size of the tumor and other factors influencing prognosis of carcinoma of the head of the pancreas

    Am J Gastroenterol

    (1985)
  • R. Tsuchiya et al.

    Radical resection of pancreatic and periampullary neoplasms. Pancreatoduodenectomy

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    Presented at the 62nd Annual Meeting of the Central Surgical Association, Tucson, Arizona, March 10-15, 2005.

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