Dataset Information

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

ABSTRACT:

Background

The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short-term outcomes and equal long-term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes.

Aim

To evaluate outcomes according to the registration periods.

Methods

The overall registration period was divided into three periods (first: 2004-2005, second: 2006-2007 and third: 2008-2009). Short-term and long-term outcomes were compared between registration periods.

Results

In total, 1057 patients were registered. Numbers of patients undergoing each approach for each of the three periods (1st/2nd/3rd) were 528 for OP (106/244/178) and 529 for LAP (106/246/177). Operation time (minutes) did not change between the periods for OP (160/156/161) or LAP (205/211/219). Blood loss (mL) gradually decreased in the latter two periods: (119/80/75) for OP and (35/28/25) for LAP. Incidence of complications (%) decreased in the latter periods for OP (27.6/20.3/21.3), whereas that for LAP remained consistently low (14.3/14.8/13.6). There was no particular trend in 5-year overall survival and recurrence-free survival depending on the period regardless of treatment. D3 dissection rates were 95% or more for all periods in both groups.

Conclusions

Operation time and survival rates did not change over time, whereas blood loss in OP improved in the latter periods. Quality control applied in this trial might have been effective in producing such safe endpoints. (ClinicalTrials.gov, number NCT00147134, UMIN Clinical Trials Registry, number C000000105.).

SUBMITTER: Fujii S

PROVIDER: S-EPMC6524094 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

Fujii Shoichi S Akagi Tomonori T Inomata Masafumi M Katayama Hiroshi H Mizusawa Junki J Ota Mitsuyoshi M Saito Shuji S Kinugasa Yusuke Y Yamaguchi Shigeki S Sato Takeo T Kitano Seigo S

Annals of gastroenterological surgery 20190326 3

<h4>Background</h4>The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short-term outcomes and equal long-term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes.<h4>Aim</h4>To evaluate outcomes according to the registration periods.<h4>Methods</h4>The overall registration period was divide ...[more]

PMID: 31131359

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Project description:PurposeLaparoscopic liver resection has advantages over open liver resection, including reduced blood loss and shorter hospital stays. Laparoscopic central hepatectomy (CH) is a highly challenging procedure, and such outcomes can only be achieved with a high level of expertise in laparoscopic liver surgery. Laparoscopic CH remains challenging, with safety and efficacy unclear. This study retrospectively evaluated the intra- and short-term outcomes of laparoscopic versus open CH and assessed safety and efficacy of laparoscopic surgery.MethodsCH included anterior sectionectomy (AS) and central bisectionectomy (CBS) (excluding cases with biliary reconstruction). The study comprised 38 patients receiving CH in our department from January 2010 to November 2023.ResultsThe laparoscopic group included 14 cases and the open group 24. AS/CBS was performed in 14/10 open group cases and 6/8 laparoscopic group cases. Short-term surgical outcomes showed no significant between-group difference in operative time, but the laparoscopic group lost significantly less blood (250 vs. 985 mL; p = 0.001) and the transfusion rate was lower (14% vs. 46%; p = 0.004). Among postoperative outcomes, incidence of bile leakage was not significantly different (33% vs. 42%; p = 0.42), but the laparoscopic group had significantly less postoperative ascites (0% vs. 17%; p = 0.047), fewer surgical site infections (SSI) (0% vs. 21%; p = 0.02), and shorter postoperative hospital stay (14 vs. 30 days; p = 0.005). The risk factor for bile leakage in CH by univariate and multivariate analysis was tumor proximity to the right anterior Glissonean pedicle (OR = 6.84; 95% CI = 1.67-32.7; p = 0.01).ConclusionLaparoscopic CH could be performed safely. Compared to open surgery, laparoscopic CH was effective in reducing blood loss, postoperative ascites, SSIs, and shortening postoperative hospital stay. However, tumors close to the root of the right anterior Glissonean pedicle were considered a risk factor for postoperative bile leakage and require caution.

Project description:Studies evaluating the outcomes after laparoscopic resections of transverse colon cancers are scant. This manuscript aimed to compare surgical and oncological outcomes after laparoscopic (Lap) and open procedures for transverse colon carcinomas. All consecutive patients who underwent resection for a cancer located in the transverse colon between 2003 and 2019 were reviewed. Patients were categorized according to the surgical approach (Lap versus open) and groups were compared. Outcome measures were the short-term results, complications and functional recovery; moreover, recurrence-free survival (RFS) and overall survival (OS) rates were compared overall and after propensity score matching (PSM) based on age, sex, ASA classification, BMI, carcinoembryonic antigen (CEA) level, use of postoperative chemotherapy, location of tumour, stage and grading, operation time, blood loss and complications. Of 248 transverse resections reviewed, 146 (81 Lap and 65 open) were selected for data analysis. Blood loss, fluid intake and the incidence of wound infection were significantly lower and the hospital stay was significantly shorter in the Lap group (P < 0.001). The operation time and incidence of complications (Clavien-Dindo classification grade 3 or above) did not differ significantly between the two groups. Mean follow-up was of 75.4 months in the Lap group and 78.6 months in the open group. Regression analyses showed that OS was associated with the postoperative carcinoembryonic antigen (CEA) level (hazard ratio 1.18 (95 per cent c.i. 1.10 to 1.27); P < 0.001), BMI (hazard ratio 0.81 (95 per cent c.i. 0.68 to 0.96); P = 0.017), operation time (hazard ratio 0.99 (95 per cent c.i. 0.97 to 1.00; P = 0.010), and postoperative chemotherapy (hazard ratio 0.27 (95 per cent c.i. 0.08 to 0.96); P = 0.042), while RFS was associated with the postoperative CEA level (hazard ratio 1.13 (95 per cent c.i. 1.07 to 1.20); P < 0.001). PSM selected 42 patients for data comparison of long-term results, and showed no significant differences between groups (RFS: P = 0.530; OS: P = 0.561). Lap and open resections for transverse colon cancer provided similar outcomes in terms of severe post-operative complication and long-term results.

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Dataset Information

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

Background

Aim

Methods

Results

Conclusions

Publications

Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404.

Similar Datasets

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