Short-term surgical outcomes from a randomized controlled trial to evaluate laparoscopic and open D3 dissection for stage II/III colon cancer: Japan Clinical Oncology Group Study JCOG 0404.

Abstract

OBJECTIVE:

A randomized controlled trial to confirm the non-inferiority of laparoscopic surgery to open surgery in terms of overall survival was conducted, and short-term surgical outcomes are demonstrated.

BACKGROUND:

The efficacy and safety outcome of laparoscopic surgery for clinical stages II/III colon cancer undergoing Japanese D3 dissection are still unclear.

METHODS:

Eligibility criteria included colon cancer; tumor located in the cecum, ascending, sigmoid, or rectosigmoid colon; T3 or T4 without involvement of other organs; N0-2; and M0. Patients were randomized preoperatively and underwent tumor resection with D3 dissection. Safety analyses were conducted by per-protocol set.

RESULTS:

A total of 1057 patients were randomized between October 2004 and March 2009. By per-protocol set, 524 patients who underwent open surgery and 533 patients who underwent laparoscopic surgery were analyzed. D3 dissection was performed in 521 (99.4%) patients in the open surgery arm and 529 (99.2%) patients in the laparoscopic surgery arm. Conversion to open surgery was needed for 29 (5.4%) patients. Patients assigned to laparoscopic surgery had less blood loss (P < 0.001), although laparoscopic surgery lasted 52 minutes longer (P < 0.001). Laparoscopic surgery was associated with a shorter time to pass first flatus, decreased use of analgesics after 5 postoperative days, and a shorter hospital stay. Morbidity [14.3% (76/533) vs 22.3% (117/524), P < 0.001] was lower in the laparoscopic surgery arm.

CONCLUSIONS:

Short-term surgical safety and clinical benefits of laparoscopic D3 dissection were demonstrated. The primary endpoint will be reported after the primary analysis, planned for 2014.

• Authors: Seiichiro Yamamoto, Masafumi Inomata, Hiroshi Katayama, Junki Mizusawa, Tsuyoshi Etoh, Fumio Konishi, Kenichi Sugihara, Masahiko Watanabe, Yoshihiro Moriya, Seigo Kitano, Japan Clinical Oncology Group Colorectal Cancer Study Group
• Journal: Annals of surgery (Ann Surg) Vol. 260 Issue 1 Pg. 23-30 (Jul 2014) ISSN: 1528-1140 [Electronic] United States
• PMID: 24509190 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Colectomy (methods)
• Colonic Neoplasms (mortality, secondary, surgery)
• Colonoscopy
• Follow-Up Studies
• Hospital Mortality (trends)
• Japan (epidemiology)
• Laparoscopy
• Length of Stay (trends)
• Lymph Node Excision (methods)
• Lymphatic Metastasis
• Neoplasm Staging
• Retrospective Studies
• Survival Rate (trends)
• Time Factors
• Tomography, X-Ray Computed
• Treatment Outcome