Effect of laparoscopic-assisted resection vs open resection of stage II or III rectal cancer on pathologic outcomes the ACOSOG Z6051 randomized clinical trial

Fleshman, J., Branda, M., Sargent, D.J., Boller, A.M., George, V., Abbas, M., Peters, W.R., Maun, D., Chang, G., Herline, A., Fichera, A., Mutch, M., Wexner, S., Whiteford, M., Marks, J., Birnbaum, E., Margolin, D., Larson, D., Marcello, P., Posner, M., Read, T., Monson, J., Wren, S.M., Pisters, P.W.T. and Nelson, H. (2015) Effect of laparoscopic-assisted resection vs open resection of stage II or III rectal cancer on pathologic outcomes the ACOSOG Z6051 randomized clinical trial. JAMA: The Journal of the American Medical Association, 314 13: 1346-1355. doi:10.1001/jama.2015.10529


Author Fleshman, J.
Branda, M.
Sargent, D.J.
Boller, A.M.
George, V.
Abbas, M.
Peters, W.R.
Maun, D.
Chang, G.
Herline, A.
Fichera, A.
Mutch, M.
Wexner, S.
Whiteford, M.
Marks, J.
Birnbaum, E.
Margolin, D.
Larson, D.
Marcello, P.
Posner, M.
Read, T.
Monson, J.
Wren, S.M.
Pisters, P.W.T.
Nelson, H.
Title Effect of laparoscopic-assisted resection vs open resection of stage II or III rectal cancer on pathologic outcomes the ACOSOG Z6051 randomized clinical trial
Journal name JAMA: The Journal of the American Medical Association   Check publisher's open access policy
ISSN 1538-3598
0098-7484
Publication date 2015-10-01
Year available 2015
Sub-type Article (original research)
DOI 10.1001/jama.2015.10529
Open Access Status Not yet assessed
Volume 314
Issue 13
Start page 1346
End page 1355
Total pages 10
Place of publication Chicago, IL, United States
Publisher American Medical Association
Language eng
Abstract IMPORTANCE Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease.
Formatted abstract
Importance Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease.

Objective To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen.

Design, Setting, and Participants A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection.

Interventions Standard laparoscopic and open approaches were performed by the credentialed surgeons.

Main Outcomes and Measures The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation.

Results Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, −5.3%; 1-sided 95% CI, −10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, −0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, −0.7%; 95% CI, −4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, −4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91).

Conclusions and Relevance Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients.

Trial Registration clinicaltrials.gov Identifier: NCT00726622
Keyword Medicine, General & Internal
General & Internal Medicine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 165 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 172 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Sat, 11 Feb 2017, 01:00:33 EST by Web Cron on behalf of Learning and Research Services (UQ Library)