Faculty Collaboration Database

Feasibility of a randomized trial of extended lymphadenectomy for pancreatic cancer. Arch Surg 2005 Jun;140(6):584-9; discussion 589-91

Date

06/22/2005

Pubmed ID

15967906

DOI

10.1001/archsurg.140.6.584

Scopus ID

2-s2.0-21244503216 (requires institutional sign-in at Scopus site)   94 Citations

Abstract

HYPOTHESIS: The required sample size of a prospective randomized trial comparing standard pancreaticoduodenectomy with pancreaticoduodenectomy plus extended lymphadenectomy for pancreatic adenocarcinoma is prohibitively large, making such a trial infeasible.

DESIGN: Retrospective cohort study.

SETTING: Comprehensive cancer center.

PATIENTS: We identified 158 patients who underwent pancreaticoduodenectomy for pancreatic adenocarcinoma with separate pathologic analysis of second-echelon lymph nodes, defined as lymph nodes along the proximal hepatic artery and/or the great vessels.

MAIN OUTCOME MEASURES: To estimate the sample size required for a randomized trial, we devised a biostatistical model with the following assumptions: extended lymphadenectomy can benefit only patients who (1) actually have disease removed from second-echelon nodes, (2) have microscopically negative (R0) primary tumor resection margins, and (3) do not have visceral metastatic (M0) disease.

RESULTS: Seventy-six patients (48.1%) had negative first- and second-echelon lymph nodes, 65 (41.1%) had positive first-echelon and negative second-echelon lymph nodes, and 17 (10.8%) had positive first- and second-echelon lymph nodes. Patients with positive second-echelon lymph nodes had an R0 resection rate of 47.1%. At a median follow-up of 65.1 months, 4 patients with positive second-echelon lymph nodes were alive, but 3 had recurrent disease. This implies that only 1 patient (5.9%) with positive second-echelon lymph nodes may have had true M0 disease. Therefore, only 0.3% of patients (10.8% with positive second-echelon lymph nodes x 47.1% with R0 resection x 5.9% with M0 disease) may achieve a survival benefit from extended lymphadenectomy. A randomized trial of standard pancreaticoduodenectomy vs pancreaticoduodenectomy with extended lymphadenectomy would require 202 000 patients in each study arm to detect such a small difference.

CONCLUSIONS: Definitive evaluation of the potential benefits of extended lymphadenectomy would require a prohibitively large sample size. Adequately powered randomized trials to address the potential benefit of extended lymphadenectomy are infeasible.

Author List

Pawlik TM, Abdalla EK, Barnett CC, Ahmad SA, Cleary KR, Vauthey JN, Lee JE, Evans DB, Pisters PW

Author

Douglas B. Evans MD Chair, Professor in the Surgery department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adenocarcinoma
Duodenum
Feasibility Studies
Female
Humans
Lymph Node Excision
Lymphatic Metastasis
Male
Middle Aged
Models, Statistical
Pancreatectomy
Pancreatic Neoplasms
Randomized Controlled Trials as Topic
Retrospective Studies
Sample Size