Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

Jeong, Seung Yong; Park, Ji Won; Nam, Byung Ho; Kim, Sohee; Kang, Sung Bum; Lim, Sangwoo; Choi, Hyo Seong; Kim, Duck Woo; Chang, Hee Jin; Kim, Dae Yong; Jung, Kyung Hae; Kim, Tae You; Kang, Gyeong Hoon; Chie, Eui Kyu; Kim, Sun Young; Sohn, Dae Kyung; Kim, Jae Sung; Lee, Hye Seung; Kim, Jee Hyun; Oh, Jae Hwan

doi:10.1016/s1470-2045(14)70205-0

Cited by 755 publications

(564 citation statements)

References 25 publications

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“…Pathological assessment of the resected specimen in this study showed no statistical difference between the groups. The authors in this study supported the use laparoscopic rectal surgery after neoadjuvant chemoradiotherapy as it had an improved short-term benefit regarding post-operative outcomes and its pathological assessment was equivalent between the two groups [20] .…”

Section: Evidence From Multicentre Randomised Control Trials (Short Tmentioning

confidence: 63%

“…In the COREAN trial the 3-year disease free survival was 79.2% for laparoscopic surgery and 72.5% for the open resection group [20] , which was not statistically significant. There was also no significant difference in the rates of local recurrence or overall survival (disease free survival P = 0.34).…”

Section: Longer Term Oncological Outcomes For Rectal Surgerymentioning

confidence: 84%

“…The landmark multicentre RCTs include the early UK-based MRC CLASICC (Conventional vs. Laparoscopic-Assisted Surgery in Colorectal Cancer) trial [27] , the North American COLOR (Colon Cancer Laparoscopic or Open Resection) II trial [18] , the South Korean based COREAN (Comparison of Open Versus Laparoscopic Surgery for mid or low Rectal Cancer After Neoadjuvant Chemoradiotherapy) trial [20] , the Australian based ALaCaRT (Australian Laparoscopic Cancer of the Rectum Trial) trial [17] and the US based ACOSOG Z6051 [10] .…”

Section: Evidence From Multicentre Randomised Control Trials (Short Tmentioning

confidence: 99%

“…Several studies have shown laparoscopic rectal surgery has failed to reach noninferiority when compared to open resection in terms of short term pathological outcomes [10,17] . However, early reports from some of the major trials are suggesting that laparoscopic rectal surgery and open resection are equivalent regarding long-term disease-free survival, overall survival and local recurrence [18][19][20] .…”

Section: Introductionmentioning

confidence: 99%

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Is laparoscopic rectal surgery really not non-inferior?

O'Donohue¹,

Warren²,

Chow³

2018

MIS

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Laparoscopic rectal surgery has gained popularity over the last 20 years. Currently there are still questions surrounding the safety and efficacy of this technique as compared to the traditional open modalities. To date, despite the initial enthusiasm for laparoscopic rectal surgery this technique is yet to reach non-inferiority in trials when compared to open resection. This review article discusses the current evidence exploring the value of laparoscopic rectal surgery. It will discuss its evolution over the last 20 years, exploring all the major randomised control trials and their results. It is our belief that laparoscopic rectal surgery for malignancy is not non-inferior to conventional open surgery.

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Section: Evidence From Multicentre Randomised Control Trials (Short Tmentioning

confidence: 63%

Section: Longer Term Oncological Outcomes For Rectal Surgerymentioning

confidence: 84%

Section: Evidence From Multicentre Randomised Control Trials (Short Tmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Is laparoscopic rectal surgery really not non-inferior?

O'Donohue¹,

Warren²,

Chow³

2018

MIS

View full text Add to dashboard Cite

show abstract

“…Third, the follow‐up duration was relatively short. Although we thought that LR would generally be identified within 3 years after surgery35, 36, 37 and some RCT were also designed to compare the OS, DFS, or LR at this time point,6, 38, 39 longer follow up is required to confirm these results. We plan to follow up this cohort until 5 years after surgery.…”

Section: Discussionmentioning

confidence: 99%

Local control of sphincter‐preserving procedures and abdominoperineal resection for locally advanced low rectal cancer: Propensity score matched analysis

Okamura

Hida

Yamaguchi

et al. 2017

Annals of Gastroent Surgery

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Sphincter‐preserving procedures (SPPs) for surgical treatment of low‐lying rectal tumors have advanced considerably. However, their oncological safety for locally advanced low rectal cancer compared with abdominoperineal resection (APR) is contentious. We retrospectively analyzed cohort data of 1500 consecutive patients who underwent elective resection for stage II‐III rectal cancer between 2010 and 2011. Patients with tumors 2‐5 cm from the anal verge and clinical stage T3‐4 were eligible. Primary outcome was 3‐year local recurrence rate, and confounding effects were minimized by propensity score matching. The study involved 794 patients (456 SPPs and 338 APR). Before matching, candidates for APR were more likely to have lower and advanced lesions, whereas SPPs were carried out more often following preoperative treatment, by laparoscopic approach, and at institutions with higher case volume. After matching, 398 patients (199 each for SPPs and APR) were included in the analysis sample. Postoperative morbidity was similar between the SPPs and APR groups (38% vs 39%; RR 0.98, 95% CI 0.77‐1.27). Margin involvement was present in eight patients in the SPPs group (one and seven at the distal and radial margins, respectively) and in 12 patients in the APR group. No difference in 3‐year local recurrence rate was noted between the two groups (11% vs 14%; HR 0.77, 95% CI 0.42‐1.41). In this observational study, comparability was ensured by adjusting for possible confounding factors. Our results suggest that SPPs and APR for locally advanced low rectal cancer have demonstrably equivalent oncological local control.

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Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes

Fleshman

Branda

Sargent

et al. 2015

JAMA

957

705

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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

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Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): survival outcomes of an open-label, non-inferiority, randomised controlled trial

Cited by 755 publications

References 25 publications

Is laparoscopic rectal surgery really not non-inferior?

Is laparoscopic rectal surgery really not non-inferior?

Local control of sphincter‐preserving procedures and abdominoperineal resection for locally advanced low rectal cancer: Propensity score matched analysis

Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes

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