Tiago L Ghezzi1,2,3, Márcia P Pereira4, Oly C Corleta5, Antonio N Kalil6. 1. Division of Coloproctology, Hospital Moinhos de Vento, 2350 Ramiro Barcelos St, 600, Porto Alegre, RS, 90035-903, Brazil. tghezzi@hcpa.edu.br. 2. Division of Coloproctology, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil. tghezzi@hcpa.edu.br. 3. Post-graduate Program in Health Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil. tghezzi@hcpa.edu.br. 4. Anatpat Surgical Pathology Lab, Porto Alegre, Brazil. 5. Division of General Surgery, Department of Surgery, Hospital de Clinicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. 6. Post-graduate Program in Health Sciences, Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil.
Abstract
PURPOSE: This study aimed to compare the performance of two lymph node revealing solutions. METHODS: This randomized clinical trial (NTC02704988) investigated patients with colon or rectal cancer who underwentsurgical resection with D2 lymphadenectomy. Specimens submitted for conventional pathological examination were randomly assigned for additional fixation with Carnoy or GEWF solution, and dissection was performed to examine the missed lymph nodes. The number of lymph nodes retrieved, additional identified metastatic lymph nodes, lymph node upstaging, and complementary indication of adjuvant therapy were investigated. RESULTS: The number of lymph nodes retrieved was significantly higher with the use of lymph node revealing solutions than with the conventional method in colon cancer (GEWF: 29.5 vs 27; p < 0.001; Carnoy: 27.7 vs 25.2; p < 0.001) and rectal cancer (GEWF: 25.8 vs 23.6; p < 0.001; Carnoy: 23.1 vs 20.8; p < 0.001). There were no differences between the solutions and conventional examination with respect to the median number of additional metastatic lymph nodes identified (0 in all arms), the number of patients with lymph node upstaging (colon cancer: 1 in the Carnoy arm, 0 in the GEWFarm; rectal cancer: 1 in the GEWF arm, 0 in the Carnoy arm), or the number of patients with complementary indication of adjuvant therapy (colon cancer: 1 in the Carnoy arm, 0 in the GEWFarm; rectal cancer: 0 in both arms). CONCLUSION: Despite the higher number of lymph nodes retrieved, neither solution resulted in significant changes in patient staging or treatment. Both solutions exhibited equal performance with respect to all outcomes. TRIAL REGISTRATION: NTC02704988.
RCT Entities:
PURPOSE: This study aimed to compare the performance of two lymph node revealing solutions. METHODS: This randomized clinical trial (NTC02704988) investigated patients with colon or rectal cancer who underwent surgical resection with D2 lymphadenectomy. Specimens submitted for conventional pathological examination were randomly assigned for additional fixation with Carnoy or GEWF solution, and dissection was performed to examine the missed lymph nodes. The number of lymph nodes retrieved, additional identified metastatic lymph nodes, lymph node upstaging, and complementary indication of adjuvant therapy were investigated. RESULTS: The number of lymph nodes retrieved was significantly higher with the use of lymph node revealing solutions than with the conventional method in colon cancer (GEWF: 29.5 vs 27; p < 0.001; Carnoy: 27.7 vs 25.2; p < 0.001) and rectal cancer (GEWF: 25.8 vs 23.6; p < 0.001; Carnoy: 23.1 vs 20.8; p < 0.001). There were no differences between the solutions and conventional examination with respect to the median number of additional metastatic lymph nodes identified (0 in all arms), the number of patients with lymph node upstaging (colon cancer: 1 in the Carnoy arm, 0 in the GEWF arm; rectal cancer: 1 in the GEWF arm, 0 in the Carnoy arm), or the number of patients with complementary indication of adjuvant therapy (colon cancer: 1 in the Carnoy arm, 0 in the GEWF arm; rectal cancer: 0 in both arms). CONCLUSION: Despite the higher number of lymph nodes retrieved, neither solution resulted in significant changes in patient staging or treatment. Both solutions exhibited equal performance with respect to all outcomes. TRIAL REGISTRATION: NTC02704988.
Authors: Bruno Märkl; C Herbst; C Cacchi; T Schaller; I Krammer; G Schenkirsch; A Probst; H Spatz Journal: Int J Colorectal Dis Date: 2013-01-12 Impact factor: 2.571