ID 000000648 (University Hospital Medical Information Network (UMIN) database).

No abstract

Background The prognosis of patients with linitis plastica (type 4) and large (≥ 8 cm) ulcero-invasive-type (type 3) gastric cancer is extremely poor, even after extended surgery and adjuvant chemotherapy. Given the promising results of our previous phase II study evaluating neoadjuvant chemotherapy (NAC) with S-1 plus cisplatin (JCOG0210), we performed a phase III study to confirm the efficacy of NAC in these patients, with the safety and surgical results are presented here. Methods Eligible patients were randomized to gastrectomy plus adjuvant chemotherapy with S-1 (Arm A) or NAC followed by gastrectomy + adjuvant chemotherapy (Arm B). The primary endpoint was the overall survival (OS). This trial is registered at the UMIN Clinical Trials Registry as C000000279. Results From February 2007 to July 2013, 300 patients were randomized (Arm A 149, Arm B 151). NAC was completed in 133 patients (88%). Major grade 3/4 adverse events during NAC were neutropenia (29.3%), nausea (5.4%), diarrhea (4.8%), and fatigue (2.7%). Gastrectomy was performed in 147 patients (99%) in Arm A and 139 patients (92%) in Arm B. The operation time was significantly shorter in Arm B than in Arm A (median 255 vs. 240 min, respectively; p = 0.024). There were no significant differences in Grade 2-4 morbidity and mortality (25.2% and 1.3% in Arm A and 15.8% and 0.7% in Arm B, respectively). Conclusions NAC for type 4 and large type 3 gastric cancer followed by D2 gastrectomy can be safely performed without increasing the morbidity or mortality.Human rights statement All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the 1964 Declaration of Helsinki and later versions.Informed consent Informed consent was obtained from all patients for inclusion in the study.

Clinical diagnosis of T3/T4 tumors was not an optimal criterion to select patients for intensive NAC trials because more than 10% of patients with pathological stage I disease were included. We propose the criterion "cT3/T4 and cN1/N2/N3" instead.

Three surgical procedures for U-EGC did not result in differences in weight loss, but PG-EG and PG-JI were better than TG-RY according to some nutritional markers. In U-EGC, where patients are expected to have long survival times, PG-EG and PG-JI should be used rather than TG-RY.

RY reconstruction was not superior to BI in terms of body weight change or other aspects of nutritional status at 1 year after surgery, although RY more effectively prevented reflux esophagitis and remnant gastritis after distal gastrectomy.

Gastrectomy with Roux-Y reconstruction for gastric cancer leaves several spaces that can cause internal hernia formation. Laparoscopic surgery and postoperative body weight loss are potential risk factors.

Background Both Billroth I (B-I) and Roux-en-Y (R-Y) reconstructions are commonly performed as standard procedures, but it has yet to be determined which reconstruction is better for patients. A randomized prospective phase II trial with body weight loss at 1 year after surgery as a primary endpoint was performed to address this issue. The current report delivers data on the quality of life and degree of postoperative dysfunction, which were the secondary endpoints of this study.Methods Gastric cancer patients who underwent distal gastrectomy were intraoperatively randomized to B-I or R-Y. Postsurgical QOL was evaluated using the EORTC QLQ-C30 and DAUGS 20. Results Between August 2005 and December 2008, 332 patients were enrolled in a randomized trial comparing B-I versus R-Y. A mail survey questionnaire sent to 327 patients was completed by 268 (86.2%) of them. EORTC QLQ-C30 scores were as follows: global health status was similar in each group (B-I 73.5 ± 18.8, R-Y 73.2 ± 20.2, p = 0.87). Scores of five functional scales were also similar. Only the dyspnea symptom scale showed superior results for R-Y than for B-I (B-I 13.6 ± 17.9, R-Y 8.6 ± 16.3, p = 0.02). With respect to DAUGS 20, the total score did not differ significantly between the R-Y and B-I groups (24.8 vs. 23.6, p = 0.41). Only reflux symptoms were significantly worse for B-I than for R-Y (0.7 ± 0.6 vs. 0.5 ± 0.6, p = 0.01). Conclusions The B-I and R-Y techniques were generally equivalent in terms of postoperative QOL and dysfunction. Both procedures seem acceptable as standard reconstructions after distal gastrectomy with regard to postoperative QOL and dysfunction.