scholarly journals Does a laparoscopic approach attenuate the body weight loss and lean body mass loss observed in open distal gastrectomy for gastric cancer? a single-institution exploratory analysis of the JCOG 0912 phase III trial

2017 ◽  
Vol 21 (2) ◽  
pp. 345-352 ◽  
Author(s):  
Toru Aoyama ◽  
Tsutomu Sato ◽  
Tsutomu Hayashi ◽  
Takanobu Yamada ◽  
Haruhiko Cho ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Distal Gastrectomy ◽  
Laparoscopic Approach ◽  
Body Weight Loss ◽  
The Body ◽  
Phase Iii ◽  
Open Distal Gastrectomy ◽  
Single Institution ◽  
Body Mass Loss ◽  
Phase Iii Trial

Risk factors for the continuation of S-1 adjuvant chemotherapy for gastric cancer analyzed from the JCOG1104 phase III trial.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 196-196
Author(s):  
Takanobu Yamada ◽  
Takaki Yoshikawa ◽  
Junki Mizusawa ◽  
Hitoshi Katai ◽  
Akinori Takagane ◽  
...  
Keyword(s):  
Risk Factors ◽  
Gastric Cancer ◽  
Weight Loss ◽  
Adjuvant Chemotherapy ◽  
Treatment Period ◽  
Body Weight Loss ◽  
Treatment Completion ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
One Year

196 Background: The phase III trial (JCOG1104), comparing between 4- (6 months) and 8-course (1 year) of S-1 as the adjuvant chemotherapy for pathological stage II gastric cancer, registered a total of 590 patients between Feb. 2012 and Mar. 2017 until the study was terminated due to futility at the interim analysis (relapse-free survival at 3 years: 93.1% in the 8-course group and 89.8% in the 4-course group). Non-inferiority of the 4-course to the 8-course was not shown, highlighting a continuation of S-1 adjuvant chemotherapy for one year. This preplanned exploratory study investigated the risk factors for time to treatment failure (TTF). Methods: TTF was defined as the time from randomization to the date of termination of S-1 before the planned treatment period, relapse, or any cause of death, whichever came first, and censored on the last date of contact for a surviving patient after completing the planned treatment or the last date of S-1 in the patients under the protocol treatment when the trial was closed. The risk factor of TTF was analyzed by Cox proportional hazard model using the variables of the planned treatment period, PS, age, sex, body weight loss (percentile of the body weight loss at the registration compared with that before surgery: BWL), albumin, lymphocyte count, creatinine clearance (Ccr), extent of gastrectomy (total gastrectomy vs. others), surgical approach (open vs. laparoscopic approach), and blood loss during surgery. As TTF did not reach 50%, proportion of treatment completion was compared. Results: Among 590 registered patients, this study included 530 patients (273 in the 8-course group and 257 in the 4-course group) by excluding 24 ineligible patients, 7 patients who did not start the protocol treatment, and 29 patients with unavailable data for variables. Proportion of treatment completion at 6 months estimated by Kaplan-Meier method were 89.2% in the 4-course group and 84.6% in the 8-course group ( P=0.1204), and that at 1 year was 73.6% in the 8-course group. Risk factors of TTF before 6M identified by multivariable analysis with stepwise selection method including both groups, in which all patients completed treatment were censored at 6 months, were the planned treatment period (4-courses vs. 8-course, HR 0.611, 95% Confidence interval (CI) 0.375-0.996, P=0.0482), age (continuous value, HR 1.039, 95% CI 1.004-1.074, P=0.0266), and Ccr (<80 vs. >80 ml/min, HR 1.943, 95% CI 1.105-3.415, P=0.0211). As for the TTF in the 8-course group, BWL (>10% vs <10%, HR 2.167, 95% CI 1.269-3.703, P=0.0046) and Ccr (<80 vs. >80 ml/min, HR 1.900, 95% CI 1.186-3.045, P=0.0076) were independent risk factors. Conclusions: Compared to 8-course, 4-course of S-1 adjuvant chemotherapy was associated with a higher 6-month proportion of treatment completion. When planning the adjuvant chemotherapy with S-1 for one year, BWL (>10%) and low Ccr (<80 ml/min) were risk factors for treatment failure. Clinical trial information: UMIN000007306.

Randomized controlled trial comparing Billroth-I and Roux-en-Y reconstruction in distal gastrectomy for gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 65-65 ◽  
Author(s):  
J. Fujita ◽  
H. Imamura ◽  
S. Takiguchi ◽  
K. Fujitani ◽  
I. Miyashiro ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Weight Loss ◽  
Body Weight ◽  
Postoperative Morbidity ◽  
Distal Gastrectomy ◽  
Controlled Trial ◽  
Body Weight Loss ◽  
The Body ◽  
Billroth I ◽  
Randomized Controlled

65 Background: In distal subtotal gastrectomy for gastric cancer, Billroth-I (B-I) reconstruction has been performed predominantly in Japan, while increasing number of surgeons chose Roux-en-Y (R-Y) reconstruction recently. To evaluate the safety and superiority of R-Y we conducted a multi-institutional prospective randomized controlled trial. Methods: Gastric cancer patients who underwent distal gastrectomy were randomized to B-I or R-Y intraoperatively. The primary endpoint was the ratio of body weight loss 1 year after surgery, the secondary endpoints were the incidence of delayed gastric emptying (DGE) and postoperative morbidity. Results: Between Aug 2005 and Dec 2008, a total of 332 patients were enrolled and 163 patients were assigned to B-I and 169 patients to R- Y. The patient's characteristics were well balanced between the two groups. The operation time was significantly longer in R-Y than B-I (median 180 min in B-I vs 214 min in R-Y, p < 0.0001). The postoperative morbidity was 14 patients (8.6%) in B-I and 23 (13.6%) in R-Y (p = 0.14), the incidence of DGE was 7 (4.3%) in B-I vs 16 (9.5%) in R-Y (p = 0.06), and the hospital stay after surgery was 14.1days in B-I vs 16.4 days in R-Y (p = 0.02). There was no hospital death in the two groups. The body weight loss at 1 year after surgery compared to preoperation was -5.4kg (-9.1%) in B-I vs -6.2kg (-9.8%) in R-Y (p = 0.11). Conclusions: The advantage of R- Y reconstruction compared to B-I was not proved in terms of postoperative morbidity either the body weight loss 1 year after surgery. No significant financial relationships to disclose.

A randomized phase III trial to determine the efficacy of postoperative antimicrobial prophylaxis in gastric cancer surgery (OGSG0501)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15576-e15576
Author(s):  
K. Inoue ◽  
H. Imamura ◽  
Y. Kimura ◽  
K. Fujitani ◽  
Y. Miyake ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Surgical Site Infection ◽  
Infection Rate ◽  
Distal Gastrectomy ◽  
Antimicrobial Prophylaxis ◽  
Cancer Surgery ◽  
Phase Iii ◽  
Site Infection ◽  
Phase Iii Trial ◽  
Gastric Cancer Surgery

e15576 Background: In Japan, antimicrobial prophylaxis (AMP) is typically administered for 3 to 4 days postoperatively in gastric cancer surgery. This far exceeds the recommended 24h or less laid out by the Centers for Disease Control (CDC) guidelines for the prevention of surgical-site infections, after a clean-contaminated operation. Methods: A multicenter randomized phase III trial was designed to evaluate the effect of postoperative AMP in gastric cancer surgery. Patients (pts) were required to have histologically proven gastric cancer which was curable by distal gastrectomy, be classifiable as ASA 1 or 2, and have adequate organ function. Pts were randomized to: (A) perioperative AMP (cefazolin 1g, at <30min before incision, every 3h intraoperative supplements) plus postoperative AMP (cefazolin 1g, twice daily for 2 postoperative days) or (B) perioperative AMP alone. Pts were stratified by institution and ASA. The primary endpoint was the incidence of surgical site infection (SSI). With 171 pts per arm, this study had 80% power to demonstrate non-inferiority with 5% margin of peri-AMP alone and 0.05 1-sided alpha. Results: 355 patients were recruited (A: 179, B: 176) in 7 centers between June 2005 and December 2007. The surgical-site infection rate was 9.0 percent (16 of 178) for peri-/post AMP and 4.5 percent (8 of 176) for peri-AMP alone, with no significant differences (Fisher's exact test: P=0.14, RR=1.98 [95%CI, 0.89–4.44]), but showing a significant non-inferiority (P<0.001). The remote site infection rate was 3.4 percent (6 of 178) for peri-/post AMP and 5.1 percent (9 of 175) for peri-AMP alone, with no significant differences (P=0.44, RR=0.66 [95%CI, 0.25- 1.70]). Conclusions: This multicenter randomized phase III trial confirms that postoperative AMP is unnecessary in patients undergoing distal gastrectomy for gastric cancer. No significant financial relationships to disclose.

Prospective multicenter feasibility study of laparoscopic sentinel basin dissection for organ preserving surgery in gastric cancer: Quality control study for phase III trial.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 143-143
Author(s):  
Keun Won Ryu ◽  
Young Joon Lee ◽  
Sang-Ho Jeong ◽  
Hoon Hur ◽  
Sang Uk Han ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Quality Control ◽  
Minimally Invasive ◽  
Laparoscopic Approach ◽  
Multicenter Trial ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Maximal Diameter ◽  
Quality Control Study ◽  
Control Study

143 Background: Clinical application of sentinel node biopsy (SNB) in early gastric cancer (EGC) is still controversial even though promising multicenter trial result with minimal false negatives was already reported from Japan. Moreover laparoscopic approach is considered as minimally invasive in addition to organ preserving surgery. Therefore we conducted this study as a prerequisite quality control for phase III trial. Methods: Laparoscopic SBD was performed in patients with preoperative stage T1-2N0 and tumor size less than 4cm in maximal diameter. Intraoperative endoscopic submucosal injection of Technetium 99m-Human Serum Albumin and indocyanine green was done. All removed sentinel basin nodes (SBN) were investigated with intraoperative frozen Hematoxylin Eosin (HE) stain. Postoperative permanent HE stain was done for SBNs and non-SBNs. Strict checklist consisting of essential 7 steps during laparoscopic SBD was made as the quality control study for phase III trial. Ten cases completion of all essential steps in checklist were defined as qualified institution. Results: Seven institutions participated and 112 patients were enrolled in this study. However 4 patients were excluded due to screening failure. SB detection and SBD was performed in 100 of the 108. Lymph node metastases were found in 11 patients at postoperative permanent HE staining and SBD contained metastatic lymph nodes in 11 patients. The detection rate of SB was 92.6% with mean number of SB and SBN was 1.68 and 9.56. Sensitivity and accuracy were 100% in this study. Frozen results of SBN were compatible with permanent reports except one patient who had one SBN with micrometastasis. As the quality control of each institution for phase III trial, 13 to 20 cases were needed based on our strict checklist. Conclusions: Laparoscopic SBD is feasible and improve the sensitivity comparing to the previous study. This study suggests the promising phase III trial of laparoscopic SBD for minimally invasive and organ preserving surgery in EGC after qualifying participating institutions. Clinical trial information: NCT01544413.

Randomized comparisons of IL-6 and lean body mass between open versus laparoscopic distal gastrectomy for gastric cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 55-55 ◽  
Author(s):  
Takaki Yoshikawa ◽  
Tsutomu Hayashi ◽  
Toru Aoyama ◽  
Junya Shirai ◽  
Hirohito Fujikawa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Distal Gastrectomy ◽  
Surgical Stress ◽  
Muscle Protein ◽  
Laparoscopic Approach ◽  
Operation Time ◽  
Phase Iii ◽  
Laparoscopic Distal Gastrectomy ◽  
Ischemic Attack ◽  
Open Versus

55 Background: Laparoscopic distal gastrectomy (LA) for gastric cancer may reduce breakdown of the muscle protein due to less surgical stress, compared with open surgery (OP). Methods: This study was performed as an exploratory analysis of a phase III trial comparing OP and LA for stage I gastric cancer in KCCH by limiting the period between May and Dec of 2011. IL-6 was measured before and 12 hours after surgery. Prealbumin and body composition were examined before and 7 days after surgery. %LBM was defined as percentile of LBM at 7 days to LBM before surgery. Values were expressed as median and range. Results: Twenty-seven patients were randomized to OP in 14 and LA in 13. Baseline: Body weight, LBM, prealbumin, and IL-6 were similar between both. Surgery and pathology D1/D1+/D2 lymph node dissections were 0/9/5 in OP and 0/9/4 in LA (p=0.785). Blood loss (g, range) and operation time (minutes, range) were 160 (50-475) and 174.5 (85-276) in OP, respectively, and 40 (5-270) and 267 (168-360) in LA, respectively, which were both significantly different (p=0.009 and 0005, respectively). Pathological T and N were similar between both. Morbidity and mortality: Any complications > grade 2 defined by Clavien-Dindo classification were 2 (14.3%) including grade 3B anastomotic stenosis and 3A pancreatic fistula in OP and 1 (7.7%) grade 2 transient ischemic attack in LA (p=0.586). Measurements: IL-6 (pg/ml, range) after 12 hours was 36.3 (14.4-405.0) in OP and 53.3 (24.1-217.0) in LA (p=1.000). Prealubumin (mg/dl, range) was 17.3 (11.7-23.7) in OP and 17.8 (10.5-28.7) in LA (p=0.680). %LBM (range) was 96.9 (93-101) in OP and 96.5 (93-100) in LA (p=1.000). When excluding the patients who developed morbidity > grade 2, IL-6 (range) was 32.1 (14.4-405.0) in OP and 49.5 (24.1-217.0) in LA (p=0.356). Prealubumin (mg/dl, range) was 17.7 (13.7-23.7) in OP and 17.8 (10.5-28.7) in LA (p=0.729). %LBM (range) was 97.1 (93-101) in OP and 97.2 (94-100) in LA (p=1.000). Conclusions: Laparoscopic approach has no impact on surgical stress and breakdown of the muscle protein after distal gastrectomy.

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