Gastric Cancer Surgery: Morbidity and Mortality Results From a Prospective Randomized Controlled Trial Comparing D2 and Extended Para-Aortic Lymphadenectomy—Japan Clinical Oncology Group Study 9501

Tokyo Metropolitan Komagome Hospital, Edo, Tōkyō, Japan
Journal of Clinical Oncology (Impact Factor: 18.43). 08/2004; 22(14):2767-73. DOI: 10.1200/JCO.2004.10.184
Source: PubMed


Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.
Only experienced surgeons in both procedures from 24 Japanese institutions participated in the study. Patients with potentially curable gastric adenocarcinoma (T2-subserosa, T3, or T4) who were surgically fit were intraoperatively randomized. Postoperative morbidity and hospital mortality were recorded prospectively in a fixed format and were compared between the two groups in this study.
A total of 523 patients were randomized between July 1995 and April 2001. Postoperative complications were reported in 24.5% of all patients. Although the morbidity for the extended surgery group (28.1%) was slightly higher than the standard group (20.9%), there was no difference in the incidence of four major complications (anastomotic leak, pancreatic fistula, abdominal abscess, pneumonia) between the two groups. Hospital mortality was reported at 0.80%: one patient in each group died of operative complications, while one from each group died of rapid progressive cancer while inpatient.
Specialized surgeons could safely perform gastrectomy with D2 lymphadenectomy in patients with low operative risks. Para-aortic lymphadenectomy could be added without increasing major surgical complications in this setting.

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    • "However, experienced groups from Japanese [31,32] and Western [13,33,34] institutions continue to perform complete D2 lymph node dissection, reporting low complication rates and survival advantages. Similar results have been obtained in recently published prospective studies [35,36]. "
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    ABSTRACT: Background The aim of the present study was to identify temporal trends in long-term survival and postoperative outcomes and to analyze prognostic factors influencing the prognosis of patients with gastric cancer (GC) treated in a 30-year interval in a tertiary referral Western institution. Methods Between January 1980 and December 2010, 1,278 patients who were diagnosed with GC at the Digestive Surgery Department, Catholic University of Rome, Italy, were identified. Among them, 936 patients underwent surgical resection and were included in the analysis. Results Over time there was a significant improvement in postoperative outcomes. Morbidity and mortality rates decreased to 19.4% and 1.6%, respectively, in the last decade. By contrast, the multivisceral resection rate steadily increased from 12.7% to 29.6%. The overall five-year survival rate steadily increased over time, reaching 51% in the last decade, and 64.5% for R0 resections. Multivariate analysis showed a higher probability of overall survival for early stages (I and II), extended lymphadenectomy, and R0 resections. Conclusions Over three decades there was a significant improvement in perioperative and postoperative care and a steady increase in overall survival.
    World Journal of Surgical Oncology 07/2014; 12(1):217. DOI:10.1186/1477-7819-12-217 · 1.41 Impact Factor
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    • "3) More than half of the patients had T1 disease and underwent limited lymph node dissection (D1+), whichmight account for the good results of our study. In particular, D2 or more radical lymph node dissection has been repeatedly reported to increase the risk of surgery-related complications [2-5]. Consistent with the previous findings, the incidence of complications was higher after D2 dissection than after D1 dissection in our study. "
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    ABSTRACT: Background Enhanced recovery after surgery (ERAS) programs have been reported to be feasible and useful for maintaining physiological function and facilitating recovery after colorectal surgery. The feasibility of such programs in gastric surgery remains unclear. This study assessed whether an ERAS program is feasible in patients who undergo gastric surgery. Methods The subjects were patients who underwent gastric surgery between June 2009 and February 2011 at the Department of Gastrointestinal Surgery, Kanagawa Cancer Center. They received perioperative care according to an ERAS program. All data were retrieved retrospectively. The primary end point was the incidence of postoperative complications. The secondary end point was postoperative outcomes. Results A total of 203 patients were studied. According to the Clavien-Dindo classification, the incidence of ≥ grade 2 postoperative complications was 10.8% and that of ≥ grade 3 complications was 3.9%. Nearly all patients did not require delay of meal step-up (95.1%). Only 6 patients (3.0%) underwent reoperation. The median postoperative hospital stay was 9 days. Only 4 patients (2.0%) required readmission. There was no mortality. Conclusions Our results suggest that our ERAS program is feasible in patients who undergo gastric surgery.
    BMC Surgery 07/2014; 14(1):41. DOI:10.1186/1471-2482-14-41 · 1.40 Impact Factor
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    • "According to the results of the JCOG9501 trial, which was a Japanese multicenter phase III study to compare D2 and D2 plus para-aortic dissection for gastric cancer surgery, the median number of harvested LNs was 54 (range: 14–161) in the D2 group and 74 (range: 30–235) in the extended para-aortic dissection group [9]. In this trial, the experienced surgeons harvested LNs from the fresh specimens immediately after surgery. "
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    ABSTRACT: Background This randomized Phase III trial will evaluate whether the methylene blue-assisted technique is efficient for harvesting lymph nodes after radical surgery for gastric cancer. Methods/design Patients that undergo distal or total gastrectomy with radical nodal dissection will be randomly assigned to Group A: the standard group, the lymph nodes (LNs) will be harvested from the fresh specimen immediately after surgery, or Group B: the methylene blue-assisted group, where the LNs will be harvested from specimens fixed with 10% buffered formalin with methylene blue for 48 hours after surgery. The primary endpoint is the ratio of the number of the harvested LNs per time (minute). The secondary endpoint is the number of harvested LNs. A 25% reduction in the ratio of harvested lymph-node/time (minute) was determined to be necessary for this test treatment, considering the balance between the cost and benefit. Retrospective data was used to estimate the ratio of the number of the harvested LNs per time (minute) to be 40/30 minutes in Group A. A 25% risk reduction and a rate of 40/22.5 minutes is expected in Group B. Therefore, the sample size required ensuring a two-sided alpha error of 5% and statistical power of 80% is 52 patients, with 26 patients per arm. The number of patients to be accrued was set at 60 in total, due to the likelihood of enrolling ineligible patients. Trial registration UMIN000008624
    BMC Cancer 03/2014; 14(1):155. DOI:10.1186/1471-2407-14-155 · 3.36 Impact Factor
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