A Randomized Phase II Study of S-1 Adjuvant Chemotherapy With or Without Hochu-ekki-to, a Japanese Herbal Medicine, for Stage II/III Gastric Cancer: The KUGC07 (SHOT) Trial

Objectives: A multicenter randomized phase II study was conducted to evaluate the effects of Hochu-ekki-to (TJ-41) for reducing adverse reactions and increasing compliance with S-1 adjuvant therapy for advanced gastric cancer.Methods: The eligibility criteria were pathological stage II/III after R0 resection. Patients received adjuvant therapy with S-1 alone (group S) or S-1 with TJ-41 (group ST) for 1 year. The primary endpoint was the completion rate of S-1. Secondary endpoints were adverse events, relative dose intensity, relapse-free survival (RFS), and overall survival (OS).Results: We randomly assigned 56 patients to group ST and 57 patients to group S. The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS between the two groups.Conclusions: TJ-41 does not increase relative dose and completion rate of S-1 significantly. J-41 may reduce toxic effects, but our findings do not support routine use of TJ-41 after gastrectomy

Comparative Outcomes of Laparoscopic Gastrectomy and Open Gastrectomy for Scirrhous Gastric Cancer: A Multicenter Retrospective Cohort Study

Objective: A multicenter retrospective cohort study was performed to compare the outcomes of laparoscopic gastrectomy (LG) versus open gastrectomy (OG) for scirrhous gastric cancer (GC) as a unique subtype also known as type 4 gastric cancer or linitis plastica. Background: Although data on the efficacy and safety of LG as an alternative to OG are emerging, the applicability of LG to scirrhous GC remains unclear. Methods: Patients with clinical type 4 GC undergoing gastrectomy at 13 hospitals from 2005 to 2015 were retrospectively reviewed. As the primary endpoint, we compared overall survival (OS) between the LG and OG groups. To adjust for confounding factors, we used multivariate Cox regression analysis for the main analyses and propensity-score matching for sensitivity analysis. Short-term outcomes and recurrence-free survival were also compared. Results: A total of 288 patients (LG, 62; OG, 226) were included in the main analysis. Postoperative complications occurred in 25.8% and 30.1%, respectively (P = 0.44). No significant difference in recurrence-free survival was observed (P = 0.72). The 5-year OS rates were 32.4% and 31.6% in the LG and OG groups, respectively (P = 0.60). The hazard ratio (LG/OG) for OS was 0.98 (95% confidence interval [CI], 0.65–1.43) in the multivariate regression analysis. In the sensitivity analyses after propensity-score matching, the hazard ratio for OS was 0.92 (95% CI, 0.58–1.45). Conclusions: Considering the hazard ratios and 95% CIs for OS, LG for scirrhous GC was not associated with worse survival than that for OG

胸腔鏡・腹腔鏡併用食道切除術の有効性：食道癌患者における術後合併症と中期腫瘍学的転帰の比較

京都大学0048新制・課程博士博士(医学)甲第17442号医博第3785号新制||医||997(附属図書館)30208京都大学大学院医学研究科医学専攻(主査)教授 上本 伸二, 教授 佐藤 俊哉, 教授 千葉 勉学位規則第4条第1項該当Doctor of Medical ScienceKyoto UniversityDA

Elevation of liver function tests after laparoscopic gastrectomy using a Nathanson liver retractor.

[Background] ： Although pneumoperitoneum has been suspected as a possible cause of transient elevation of liver function tests (LFTs) after laparoscopic surgery, liver damage by direct retraction could also influence postoperative LFTs. The aim of this study was to clarify whether laparoscopic gastrectomy (LG) using a Nathanson retractor was associated with the postoperative elevation of LFTs compared with open gastrectomy (OG). 　[Methods]： A retrospective cohort study of 199 LG and 120 OG patients was conducted. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin were measured before operation and at postoperative days 1, 3, and 7. Abnormal elevation of LFTs was defined as a grade 2 or greater elevation in any parameter. To assess the possible effect of pneumoperitoneum, patients who underwent laparoscopic (n = 324) and open (n = 56) colectomy for colorectal cancer were also compared. 　[Results] ： In both LG and OG groups, LFTs were significantly elevated postoperatively compared with baseline values. Mean ALT and total bilirubin levels on days 1, 3, and 7 were significantly higher in the LG than OG group. Abnormal elevation of LFTs was more frequent in the LG than OG group (50 vs. 12%). In multivariate analysis, LG was significantly associated with postoperative liver dysfunction (odds ratio [OR] = 7.99; 95% confidence interval [95% CI] = 3.69–18.85). No significant difference in the elevation of the LFTs was observed between laparoscopic and open colectomy (6% and 9%, respectively). 　[Conclusions]： LG resulted in frequent elevation of LFTs. Care should be taken to minimize intraoperative liver damage when performing LG using a Nathanson retractor

Laparoscopic gastrectomy for patients with a history of upper abdominal surgery: results of a matched-pair analysis.

[Purpose]The safety and feasibility of laparoscopic gastrectomy (LG) for patients who have undergone previous upper abdominal surgery (PUAS) remain unclear. A matched-pair analysis was conducted to compare the short-term outcomes of LG between patients with gastric cancer who had undergone PUAS and those who had not. [Methods]A matched-pair analysis was performed to compare the short-term outcomes of LG between 22 patients who had undergone PUAS and 66 who had not (control group). To compare the outcome to that of open gastrectomy (OG) following PUAS, a total of 143 consecutive OG patients treated during the same study period were also reviewed. [Results]Cholecystectomy was the most common type of PUAS, followed by gastrectomy. There were no significant differences between the groups in terms of the length of the operation, blood loss, and the number of retrieved lymph nodes or the rate of conversion to open surgery. The postoperative morbidity in the PUAS group (3/22, 13.6 %) was comparable to that of the control group (7/66, 10.6 %, P = 0.6981). There was no mortality within 30 days in either group. When compared to OG following PUAS (n = 23), LG was performed with significantly less blood loss with an equivalent postoperative outcome. [Conclusions]LG following PUAS is considered to be a safe and feasible surgical modality. PUAS should therefore not be regarded as a contraindication for LG

Effectiveness of combined thoracoscopic-laparoscopic esophagectomy: comparison of postoperative complications and midterm oncological outcomes in patients with esophageal cancer.

[Background ] : During esophagectomy, laparoscopy can be used together with thoracoscopy, but it is not known whether a combined thoracoscopic–laparoscopic procedure is associated with fewer postoperative complications than open esophagectomy, and without compromising oncological outcome. [Methods ] : This was a longitudinal cohort study that included 185 esophageal cancer patients, including 72 who underwent combined thoracoscopic–laparoscopic esophagectomy (TLE), 34 who underwent thoracoscopic esophagectomy (TE), and 79 who underwent open esophagectomy (OE) between January 2002 and May 2010. The main outcome measures were postoperative respiratory and overall complications. The secondary outcome was 2-year relapse-free survival (RFS). [Results ] : Respiratory complications occurred in 9 patients who underwent TLE, 13 who underwent TE, and 31 who underwent OE. TLE was associated with fewer respiratory complications (TLE vs. OE: odds ratio [OR], 0.22; 95% confidence interval [CI], 0.09–0.53 and TE vs. OE: OR, 0.71; 95% CI 0.29–1.76). Overall complications occurred in 34 patients who underwent TLE, 20 who underwent TE, and 54 who underwent OE. TLE was associated with fewer overall complications (TLE vs. OE: OR, 0.47; 95% CI 0.23–0.94 and TE vs. OE: OR, 0.51; 95% CI 0.21–1.25). The 2-year RFS rates were similar among the three groups: 71.6% for TLE, 57.7% for TE, and 58.3% for OE (TLE vs. OE: hazard ratio, 0.65; 95% CI 0.35–1.20 and TE vs. OE: hazard ratio, 0.91; 95% CI 0.45–1.82). [Conclusion ] : Unlike TE, TLE was associated with fewer postoperative complications than was OE, with no compromise of 2-year RFS. A randomized controlled trial with longer follow-up is needed

Open versus laparoscopic resection of primary tumor for incurable stage IV colorectal cancer: a large multicenter consecutive patients cohort study.

Objective: To investigate the hypothesis that laparoscopic primary tumor resection is safe and effective when compared with the open approach for colorectal cancer patients with incurable metastases. Background: There are only a few reports with small numbers of patients on laparoscopic tumor resection for stage IV colorectal cancer. Methods: Data from consecutive patients who underwent palliative primary tumor resection for stage IV colorectal cancer between January 2006 and December 2007 were collected retrospectively from 41 institutions. Short- and long-term outcomes were compared between patients who underwent laparoscopic or open resection. Results: A total of 904 patients (laparoscopic group: 226, open group: 678) with a median age of 64 years (range: 22-95) were included in the analysis. Conversion was required in 28 patients (12.4%) and the most common reasons for conversion (23/28: 82%) were bulky or invasive tumors. There was no 30-day postoperative mortality in either group. The complication rate (NCI-CTCAE grade 2-4) after laparoscopic surgery (17%) was significantly lower than that after open surgery (24%) (P = 0.02), and the difference was greater (4% vs 12%; P =grade 3) complications. The median length of postoperative hospital stay in the laparoscopic group was significantly shorter than that in the open group (14 vs 17 days; P = 0.002). In univariate analysis, overall survival for the laparoscopic group was significantly better than that for open surgery (median survival time: 25.9 vs 22.3 months, P = 0.04), although no difference was apparent in multivariate analysis. Conclusions: Compared with open surgery, laparoscopic primary tumor resection has advantages in the short term and no disadvantages in the long term. It is a reasonable treatment option for certain stage IV colorectal cancer patients with incurable disease

A Randomized Phase II Study of S-1 Adjuvant Chemotherapy With or Without Hochu-ekki-to, a Japanese Herbal Medicine, for Stage II/III Gastric Cancer: The KUGC07 (SHOT) Trial

Objectives: A multicenter randomized phase II study was conducted to evaluate the effects of Hochu-ekki-to (TJ-41) for reducing adverse reactions and increasing compliance with S-1 adjuvant therapy for advanced gastric cancer. Methods: The eligibility criteria were pathological stage II/III after R0 resection. Patients received adjuvant therapy with S-1 alone (group S) or S-1 with TJ-41 (group ST) for 1 year. The primary endpoint was the completion rate of S-1. Secondary endpoints were adverse events, relative dose intensity, relapse-free survival (RFS), and overall survival (OS). Results: We randomly assigned 56 patients to group ST and 57 patients to group S. The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS between the two groups. Conclusions: TJ-41 does not increase relative dose and completion rate of S-1 significantly. J-41 may reduce toxic effects, but our findings do not support routine use of TJ-41 after gastrectomy