Impact of a novel-covered colonic stent in obstructive colon cancer.

BACKGROUND: Although the short-term outcomes of bridge-to-surgery (BTS) procedures using self-expandable metal stents are favorable, concerns remain regarding worsened prognosis due to tissue injury in the tumor area. Herein, we describe a newly developed covered stent, the Kawasumi Jabara colonic stent™, designed to reduce tissue damage/injury associated with stent-related complications in BTS procedures. This study aimed to evaluate the efficacy and safety of the Kawasumi Jabara colonic stent as a BTS for obstructive colorectal cancer (OCC). METHODS: This multicenter retrospective observational study included 44 OCC patients who underwent BTS with stents at four facilities between September 2020 and November 2022. The groups of patients receiving the Kawasumi Jabara and non-covered colonic stents were designated Groups C and NC, respectively. Treatment outcomes related to stent placement and surgery were compared using propensity score matching (PSM) analysis. RESULTS: Groups NC and C (n = 34 and 10, respectively) showed no significant differences in sex, age, tumor location, histological type, Colorectal Obstruction Scoring System (CROSS) score, or cStage; however, the stent placement duration was shorter in Group C. No significant differences were found in terms of the technical and clinical success rates for stent placement. Stent dislocation was observed in 0 and 2 cases in Groups C and NC, respectively. PSM analysis between eight cases, each from Groups C and NC, revealed no significant differences in stent-related or surgical outcomes between the groups. However, regarding the gross injury score in the resected specimens, Group C had a lower score than Group NC (1.8 vs. 5.5), and the proportion of pathological tissue injury involving deeper layers was also lower in Group C (37.5% vs. 100%). CONCLUSIONS: Compared to conventional non-covered stents, the Kawasumi Jabara colonic stent™ demonstrated favorable safety during stent insertion, retention, and surgery, with only mild tissue injury.

A New Self-Expandable Metallic Stent with Low Axial Force and a High Axial Force Zero-Border Shows a Very Low Perforation Rate in Malignant Colorectal Obstruction: A Japanese Multicenter Prospective Study.

Background: Recently, there has been a significant increase in the utilization of self-expandable metallic stents (SEMSs) for treating malignant colorectal obstructions through colorectal stenting. The mechanical properties of SEMSs are usually considered to affect clinical outcomes of patients with malignant colorectal obstructions. Methods: This single-arm, prospective, multicenter study of SEMS with a lower axial force and high axial force zero-border included 200 patients with malignant colorectal obstruction. Technical and clinical success, stent patency, and adverse events associated with SEMS placement were evaluated. Results: One patient was excluded, and 199 patients were evaluated. The treatment intent was bridge-to-surgery in 129 and palliation in 70 patients. Technical and clinical success rates were 99.5% and 97.0%, respectively. The percentage of the ColoRectal Obstruction Scoring System scores of 3 or higher improved significantly from 19.2% before placement to 93.9% after placement. Clinical success was not achieved in five patients due to insufficient stent expansion in four patients and stent occlusion in one patient. Only one patient underwent emergency surgery for perforation of the proximal colon, far from where the stent was placed; the rescue procedure was not performed, despite no improvement in proximal dilatation due to insufficient stent expansion. Among the palliation cohort, 15 patients received chemotherapy, including molecular-targeted agents such as bevacizumab. There were no fatal cases related to stent placement. Conclusions: For management of malignant colorectal obstruction, this newly developed SEMS with low axial force and a high axial force zero-border showed high technical and clinical success rates, and an extremely low perforation rate (0.5%).

Laparoscopic versus open colectomy for locally advanced colon cancer in obese patients: a nationwide, multicenter, propensity score-based analysis of short- and long-term outcomes.

OBJECTIVE: This study evaluated the short-and long-term outcomes of laparoscopic colectomy versus open surgery in obese patients (body mass index ≥25 kg/m2) with locally advanced colon cancer to ascertain the non-inferiority of laparoscopic surgery to open surgery. METHODS: In this large cohort study (UMIN-ID: UMIN000033529), we retrospectively reviewed prospectively collected data from consecutive patients who underwent laparoscopic or open surgery for pathological stage II-III colon cancer between 2009 and 2013. A comparative analysis was performed after propensity score matching between the laparoscopic and open surgery groups. The primary endpoint was the 3-year relapse-free survival (RFS). RESULTS: We identified 1575 eligible patients from 46 institutions. Each group comprised 526 propensity score-matched patients. Comparing the laparoscopic versus open surgery group, laparoscopic surgery was significantly associated with increased median operating time (225 vs. 192.5 min; P < .0001) and decreased median estimated blood loss (20 vs. 140 ml; P < .0001). Lymph node retrieval (20 vs. 19; P = 0.4392) and postoperative complications (4.6% vs. 5.7%; P = 0.4851) were similar, postoperative hospital stay was shorter (10 vs. 12 days; P < .0001), and the 3-year RFS rates were similar (82.8 vs. 81.2%). The hazard ratio (HR) for relapse-free survival for laparoscopic versus open surgery was 0.927 (90% confidence interval [CI], 0.747-1.150, one-sided P for non-inferiority = .001), indicating that for obese patients with colon cancer, laparoscopic surgery was non-inferior to open surgery. CONCLUSION: Laparoscopic surgery in obese patients with colon cancer offers advantages in terms of short-term outcomes and no disadvantages in terms of long-term outcomes.

Risk factors of bleeding during rectal cancer surgery in obese patients in Japan.

BACKGROUND: According to several clinical trials for patients with rectal cancer, laparoscopic surgery significantly reduces intraoperative complications and bleeding compared with laparotomy and demonstrated comparable long-term results. However, obesity is considered one of the risk factors for increased surgical difficulty, including complication rate, prolonged operation time, and bleeding. METHODS: Patients with clinical pathological stage II/III rectal cancer and a body mass index of ≥25 kg/m2 who underwent laparotomy or laparoscopic surgery between January 2009 and December 2013 at 51 institutions participating in the Japan Society of Laparoscopic Colorectal Surgery were included. These patients were divided into major bleeding (>500 mL) group and minor bleeding (≤500 mL) group. The risk factors of major bleeding were evaluated by univariate and multivariate analyses. RESULTS: This study included 517 patients, of which 74 (19.9%) experienced major bleeding. Patient characteristics did not significantly differ between the two groups. The major bleeding group had a longer operative time (p < 0.001) and a larger tumor size than the minor bleeding group (p = 0.011). In the univariate analysis, age >65 years, laparotomy, operative time >300 min, and multivisceral resection were significantly associated with intraoperative massive bleeding. In the multivariate analysis, age >65 years (odds ratio [OR], 2.29; 95% confidence interval [CI], 1.13-4.82), laparotomy (OR, 20.82; 95% CI, 11.56-39.75), operative time >300 min (OR, 5.39; 95% CI, 1.67-132), and multivisceral resection (OR, 10.72; 95% CI, 2.47-64.0) showed to be risk factors for massive bleeding. CONCLUSION: Age >65 years, laparotomy, operative time >300 min, and multivisceral resection were risk factors for massive bleeding during rectal cancer surgery in patients with obesity.

A Japanese Prospective, Multicenter Study of Colonic Stenting for Palliation Using a High Axial Force Self-Expandable Metal Stent for Malignant Large Bowel Obstruction in 200 Patients.

Evidence of the efficacy and safety of colorectal stent placement for palliation remains insufficient. This single-arm, prospective, multicenter study with a WallFlex enteral colonic stent included 200 consecutive patients with malignant large bowl obstruction in the palliation cohort. The technical and clinical success, as well as stent patency and complications as short-term (≤7 days) and long-term (>7 days) outcomes, of high axial force self-expandable metal stent (SEMS) placement was evaluated. The technical and clinical success rates were 98.5% and 94.5%, respectively. Non-recurrent colorectal obstruction at 1 year was 63.9%, and 71.2% of the patients remained free of recurrent colorectal obstruction until death or the last follow-up. Fifty-six patients (28.0%) received chemotherapy, and five patients were administered bevacizumab after stent placement. The overall complication rate was 47%, including four (2.0%) early-onset and ten (5.0%) late-onset perforations, mostly due to stent-edge injury. Only the use of a long SEMS was a risk factor for perforation. In conclusion, endoscopic colorectal stenting using high axial force SEMS is an effective and safe procedure for palliation in patients with malignant colorectal obstruction. However, care should be taken to avoid perforation at the stent edge when using a long SEMS.

Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial.

OBJECTIVE: The aim of the present randomized controlled trial was to evaluate the superiority of indocyanine green fluorescence imaging (ICG-FI) in reducing the rate of anastomotic leakage in minimally invasive rectal cancer surgery. BACKGROUND: The role of ICG-FI in anastomotic leakage in minimally invasive rectal cancer surgery is controversial according to the published literature. METHODS: This randomized, open-label, phase 3, trial was performed at 41 hospitals in Japan. Patients with clinically stage 0-III rectal carcinoma less than 12 cm from the anal verge, scheduled for minimally invasive sphincter-preserving surgery were preoperatively randomly assigned to receive a blood flow evaluation by ICG-FI (ICG+ group) or no blood flow evaluation by ICG-FI (ICG- group). The primary endpoint was the anastomotic leakage rate (grade A+B+C, expected reduction rate of 6%) analyzed in the modified intention-to-treat population. RESULTS: Between December 2018 and February 2021, a total of 850 patients were enrolled and randomized. After the exclusion of 11 patients, 839 were subject to the modified intention-to-treat population (422 in the ICG+ group and 417 in the ICG- group). The rate of anastomotic leakage (grade A+B+C) was significantly lower in the ICG+ group (7.6%) than in the ICG- group (11.8%) (relative risk, 0.645; 95% confidence interval 0.422-0.987; P =0.041). The rate of anastomotic leakage (grade B+C) was 4.7% in the ICG+ group and 8.2% in the ICG- group ( P =0.044), and the respective reoperation rates were 0.5% and 2.4% ( P =0.021). CONCLUSIONS: Although the actual reduction rate of anastomotic leakage in the ICG+ group was lower than the expected reduction rate and ICG-FI was not superior to white light, ICG-FI significantly reduced the anastomotic leakage rate by 4.2%.

Long-term outcomes of standardized colonic stenting using WallFlex as a bridge to surgery: Multicenter prospective cohort study.

OBJECTIVES: The oncological outcomes, especially high recurrence rate, of bridge-to-surgery (BTS) self-expandable metallic stent (SEMS) placement remain concerning, emphasizing the necessity of standardized SEMS placement. However, its impact on long-term BTS outcomes is unknown. We investigated the long-term outcomes of BTS colonic stenting using standardized SEMS placement. METHODS: This prospective, multicenter cohort study conducted at 46 hospitals in Japan (March 2012 to October 2013) included consecutive patients with stage II and III obstructive colorectal cancer managed with BTS SEMS placement. The SEMS placement technique was standardized by information dissemination among the participating hospitals. The primary outcome was overall survival (OS) after SEMS placement, and the secondary outcomes were relapse-free survival (RFS), recurrence, and short-term outcomes of SEMS placement and surgery. RESULTS: The 1-, 3-, and 5-year OS rates were 94.1%, 77.4%, and 67.4% (Kaplan-Meier), respectively, with high technical success (99.0%, 206/208) and low perforation (1.9%, 4/208) rates. The 1-, 3-, and 5-year RFS rates were 81.6%, 65.6%, and 57.9% (Kaplan-Meier), respectively, and the overall recurrence rate was 31.0% (62/200). The RFS rate was significantly poorer in patients with perforation (n = 4) than in those without perforation (n = 196) (log-rank P = 0.017); moreover, perforation was identified as an independent factor affecting RFS (hazard ratio 3.31; 95% confidence interval 1.03-10.71, multivariate Cox regression). CONCLUSION: This large, prospective, multicenter study revealed satisfactory long-term outcomes of BTS colonic stenting using a standardized SEMS insertion method, which might be specifically due to the reduced perforation rate. (UMIN000007953).

Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404).

BACKGROUND: Previously, we conducted a randomized controlled trial (JCOG0404) for stage II/III colon cancer patients and reported that the long-term survival after open surgery (OP) and laparoscopic surgery (LAP) were almost identical; however, JCOG0404 suggested that survival of patients after LAP with tumors located in the rectosigmoid colon, cT4 or cN2 tumors, and high body mass index (BMI) might be unfavorable. AIM: To identify the patient subgroups associated with poor long-term survival in the LAP arm compared with the OP arm. METHODS: Patients aged 20-75, clinical T3 or deeper lesion without involvement of other organs, clinical N0-2 and M0 were included. The patients with pathological stage IV and R2 resection were excluded from the current analysis. In each subgroup, the hazard ratio for LAP (vs. OP) in overall survival (OS) from surgery was estimated using a multivariable Cox regression model adjusted for the clinical and pathological factors. RESULTS: In total, 1025 patients (OP, 511 and LAP, 514) were included in the current analysis. Adjusted hazards ratios for OS of patients with high BMI (>25 kg/m2), pT4, and pN2 in LAP were 3.37 (95% confidence interval [CI], 1.24-9.19), 1.33 (0.73-2.41), and 1.74 (0.76-3.97), respectively. In contrast, that of rectosigmoid colon tumors was 0.98 (0.46-2.09). CONCLUSIONS: Although LAP is an acceptable optional treatment for stage II/III colon cancer, the present subgroup analysis suggests that high BMI (>25 kg/m2), pT4, and pN2 except for RS were factors associated with unfavorable long-term outcomes of LAP in patients with colon cancer who underwent curative resection. (JCOG 0404: NCT00147134/UMIN-CTR: C000000105.).

Impact of postoperative complications after primary tumor resection on survival in patients with incurable stage IV colorectal cancer: A multicenter retrospective cohort study.

AIMS: Primary tumor resection for patients with incurable stage IV colorectal cancer can prevent tumor-related complications but may cause postoperative complications. Postoperative complications delay the administration of chemotherapy and can lead to the spread of malignancy. However, the impact of postoperative complications after primary tumor resection on survival in patients with incurable stage IV colorectal cancer remains unclear. Therefore, this study aimed to investigate how postoperative complications after primary tumor resection affect survival in this patient group. METHODS: We reviewed data on 966 patients with stage IV colorectal cancer who underwent palliative primary tumor resection between January 2006 and December 2007. We examined the association between major complications (National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade 3 or more) and overall survival using Cox proportional hazard model and explored risk factors associated with major complications using multivariable logistic regression analysis. RESULTS: Ninety-three patients (9.6%) had major complications. The 2-year overall survival rate was 32.7% in the group with major complications and 50.3% in the group with no major complications. Patients with major complications had a significantly poorer prognosis than those without major complications (hazard ratio: 1.62; 95% confidence interval: 1.21-2.18; P < .01). Male, rectal tumor, and open surgery were identified to be risk factors for major complications. CONCLUSIONS: Postoperative complications after primary tumor resection was associated with decreased long-term survival in patients with incurable stage IV colorectal cancer.

[Two Cases of Chemotherapy after Self-Expandable Metallic Stent Placement for Obstructive Sigmoid Cancer with Unresectable Liver Metastasis].

Immediate decompression and induction of chemotherapy are exceedingly critical for obstructive colorectal cancer patients with unresectable liver metastasis. Systematic chemotherapy was administered after self-expandable metallic stent(SEMS) placement in 2 patients with obstructive sigmoid cancer with unresectable liver metastasis. Chemotherapy-induced tumor shrinkage led to SEMS migration, enabling the use of an anti-VEGF drug. Eventually, both patients underwent successful management without restenosis.

[A Case of Resection of Para-Aortic Lymph Node Recurrence following Rectal Cancer Surgery].

A 54-year old man diagnosed with rectal cancer underwent laparoscopic high anterior resection with Japanese D3 lymph node dissection. The pathology results were as follows: pT2pN3M0, pStage Ⅲb(Japanese Classification of Colorectal, 8th edition). Adjuvant chemotherapy with CapeOX regimen was administered 8 courses. 1.5 years after the operation, computed tomography(CT)examination revealed a swollen para-aortic lymph node(PALN). Positron emission tomography (PET)-CT revealed PALN with high FDG uptake. We considered that neo-adjuvant chemotherapy and PALN dissection may be possible for PALN, which was isolated metastasis and curative by surgery. After 6 courses of bevacizumab-FOLFIRI therapy was administered, PALN dissection was performed. Pathological examination of the resected specimen showed adenocarcinoma in 4 of the 16 dissected lymph nodes. Histological treatment effect of preoperative therapy was Grade 1b. Postoperatively 6 courses of FOLFIRI were administered. The patient has been followed up for 7 years and 8 months after the first surgery, 5 years and 9 months after the curative resection, with no recurrence showed complete cure. Multidisciplinary treatment with anticancer drug and R0 resection was an effective treatment for isolated PALN recurrence of rectal cancer.

Determining the difference in the efficacy and safety of self-expandable metallic stents as a bridge to surgery for obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials.

PURPOSE: This study compared the feasibility and safety of endoscopic placement of self-expandable metallic stents (SEMSs) as a bridge to surgery (BTS) between patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2. METHODS: We conducted a post hoc analysis of two prospective, observational, single-arm multicenter clinical trials and performed a pooled analysis of the data. In total, 336 consecutive patients with malignant colorectal obstruction underwent SEMS placement. The primary endpoint was clinical success, defined as resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. RESULTS: High clinical (98.0% vs. 98.4%) and technical (96.7% vs. 97.8%) success rates were observed in both groups (CROSS 0 vs. CROSS 1 or 2). The adverse event rate was low. The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group. CONCLUSION: This study was the first to compare the degree of stricture in different CROSS groups and demonstrated comparable results with respect to the short-term efficacy and safety of SEMS placement as a BTS for obstructive CRC in CROSS 0, 1, and 2 patients.

Real-time monitoring of pharmaceutical properties of medical tablets during direct tableting process by hybrid tableting process parameter-time profiles.

BACKGROUND: Real-time monitoring is required for the pharmaceutical manufacturing process to produce high-quality pharmaceutical products. OBJECTIVE: Changes in the critical tableting process parameters of single-punch tableting machine due to variability in the moisture content of the raw powders were monitored by hybrid tableting pressure-time profiles. METHODS: After mixing of the raw powders, which consisted of theophylline, anhydrous lactose, potato starch and crystalline cellulose, they were stored at 0%, 45%, or 75% relative humidity (RH) for 24 h, respectively. Continuous tablet productions were carried out using the mixed powder samples at 10%, 45%, or 75% RH, respectively. The critical process parameters, such as upper and lower puncture pressures, die wall pressures, and inter-punch distances were recoded with the tableting machine, and then, tablet hardness (H), weight (W) and disintegration time (DT) of the tablets were measured. RESULTS: Hybrid tableting pressure-time profiles were obtained from various critical process parameters, and calibration models to predict pharmaceutical properties were calculated based on the hybrid profiles using a partial-least-squares regression (PLSR) method. In addition, the consistency of the calibration models were verified by constructing robust calibration models. CONCLUSION: Informetrical analysis for tablets based on hybrid tableting pressure-time profiles could evaluate the change of tablet properties dependent on the moisture content in the raw powders during the tableting process. The changes of tableting properties and elasticity were caused by agglomeration of powder particles at moisture content.

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: 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.).

Randomized phase II trial of the prophylactic use of celecoxib for the prevention of oxaliplatin-related peripheral vascular pain in Capeox (YCOG1205).

PURPOSE: Capeox is widely used as an adjuvant chemotherapy regimen of colorectal cancer that does not require central vein catheter insertion. However, oxaliplatin-related vascular pain with peripheral administration is a major adverse event. We assessed the preventive effect of Celecoxib on oxaliplatin-related vascular pain. METHODS: A multicenter study of the Yokohama Clinical Oncology Group (YCOG) in Japan. This study was an open label, randomized non-comparative phase II study between Capeox without Celecoxib (C+ Group) and with it (C- group). The primary endpoint was the appearance frequency of grade ≥ 2 vascular pain according to the Verbal Rating Scale (VRS). RESULTS: Between October 2012 and February 2014, 81 patients were recruited to this study and randomly divided into 2 groups: 38 patients in the C- group and 39 patients in the C+ group. Four cases were excluded at the analysis stage because they had not received the allocated intervention. The rate of grade ≥ 2 vascular pain was 55.3% in the C- group and 53.8% in the C+ group (p = 1.000). CONCLUSIONS: Celecoxib was unable to prevent oxaliplatin-related vascular pain in this study. However, it may be able to decrease the vascular pain that patients already have.

Factors related to difficult self-expandable metallic stent placement for malignant colonic obstruction: A post-hoc analysis of a multicenter study across Japan.

BACKGROUND AND AIM: Colorectal cancer patients often present with large bowel obstruction. Elective placement of a self-expandable metallic stent (SEMS) can relieve obstruction, but can be challenging. Previous studies have compared cases by outcomes only, but the present study investigated successful cases only to identify factors related to prolonged and difficult SEMS placement in patients with malignant colonic obstruction. METHODS: A post-hoc analysis of a multicenter clinical trial conducted between March 2012 and October 2013 at 46 facilities across Japan (UMIN000007953) was carried out; 511 patients who required SEMS placement for acute colorectal obstruction or symptomatic stricture secondary to malignant neoplasm were enrolled. Technical success rates and procedure times were recorded. Clinical and interventional parameters were investigated for their potential effect on procedure time by univariate and multivariate analyses. RESULTS: Technical success rate of SEMS placement was 98%. Median procedure time was 30 (range, 4-170) min. In 27% of patients, procedure time exceeded 45 min, indicating technically difficult placement. Multivariate analyses showed significant associations between technically difficult placement and a ColoRectal Obstruction Scoring System (CROSS) score of 0 before SEMS placement (odds ratio [OR], 1.6; P < 0.05), tumor site in the right colon (OR, 2.5; P < 0.0001), stricture length ≥5 cm (OR, 2.2; P < 0.001), peritoneal carcinomatosis (OR, 1.7; P < 0.05), and multiple SEMS placement (OR, 8.0; P < 0.01). CONCLUSION: Clinicians must anticipate technical challenges in cases with peritoneal carcinomatosis, a CROSS score of 0, or expansive strictures; such cases require experienced clinicians to carry out SEMS placement.

Self-expandable metallic stenting as a bridge to surgery for malignant colorectal obstruction: pooled analysis of 426 patients from two prospective multicenter series.

BACKGROUND: Self-expandable metallic stenting (SEMS) for malignant colorectal obstruction (MCO) as a bridge to elective surgery (BTS) is a widely used procedure. The aim of this study was to assess short-term outcomes of SEMS for MCO as BTS. METHODS: This study analyzed pooled data from BTS patients who were enrolled in two multicenter prospective single-arm observational clinical studies that used different stent types. Both studies were conducted by the Japan Colonic Stent Safe Procedure Research Group (JCSSPRG). The first study evaluated the WallFlex™ colonic stent for BTS or palliative treatment (PAL) from May 2012 to October 2013 and the second evaluated the Niti-S™ colonic stent from October 2013 to May 2014. Fifty-three facilities in Japan participated in the studies. Before each study started, the procedure had been shared with the participating institutions by posting details of the standard methods of SEMS placement on the JCSSPRG website. Patients were followed until discharged after surgery. RESULTS: A total of 723 consecutive patients were enrolled in the two studies. After excluding nine patients, the remaining 714 patients were evaluated as a per-protocol cohort. SEMS placement was performed in 426 patients (312 WallFlex and 114 Niti-S) as BTS and in 288 as PAL. In the 426 BTS patients, the technical success rate was 98.1% (418/426). The clinical success rate was 93.8% (392/418). SEMS-related preoperative complications occurred in 8.5% of patients (36/426), perforations in 1.9% (8/426), and stent migration in 1.2% (5/426). Primary anastomosis was possible in 91.8% of patients (391/426), 3.8% of whom (15/393) had anastomosis leakage. The overall stoma creation rate was 10.6% (45/426). The postoperative complication rate was 16.9% (72/426) and mortality rate was 0.5% (2/426). CONCLUSIONS: SEMS placement for MCO as BTS is safe and effective with respect to peri-procedural outcomes. Further investigations are needed to confirm long-term oncological outcomes.

[A Case of Advanced Gastric Cancer with Multiple Liver Metastases Treated with Curative Conversion Therapy after S-1 plus CDDP].

A57 -year-old man was diagnosed with advanced gastric cancer(adenocarcinoma[tub2/por1])with multiple(S3, S4, S5, S6, S8)liver and para-aortic lymph node metastases. The tumor was classified as cT4a, N3, M1, HEP, cStage IV, and the patient received chemotherapy with S-1 plus CDDP(SP). After 10 courses of SP, a CT scan revealed that the primary tumor and the metastases disappeared. The patient presented with cCR and underwent distal gastrectomy, D2 lymph node dissection, partial hepatic resection, and cholecystectomy. The histological diagnosis was classified as ypT0N0M0,(ypStage 0), pCR, and pathological Grade 3.

Laparoscopic versus open resection for transverse and descending colon cancer: Short-term and long-term outcomes of a multicenter retrospective study of 1830 patients.

INTRODUCTION: Previous randomized controlled trials demonstrated similar oncological outcomes between laparoscopic and open colectomies, except for cases involving transverse colon and splenic flexure colon cancer. The objective of this study was to confirm the oncological safety and advantages of the short-term results of laparoscopic surgery for transverse and descending colon cancer in comparison with open surgery. METHODS: The study data were retrospectively collected from the databases of 45 hospitals. Patients with transverse or descending colon cancer who underwent laparoscopic or open R0 resection were registered. The primary end-points were the 3-year overall survival and relapse-free survival rates according to pathological stage. The secondary end-points were the short-term results, including blood loss, operative time, diet intake, hospital stay, and postoperative complications. RESULTS: Of the 1830 eligible patients, 872 underwent open colectomy and 958 underwent laparoscopic colectomy. The median follow-up period was 38.4 months. The conversion rate to open resection was 4.5%. The 3-year overall survival rate of the laparoscopic group was significantly higher than that of the open group for stage I patients (96.2% vs 99.2%; P = 0.04); it was also higher for stage II (94.0% vs 95.5%) and stage III (87.4% vs 90.2%) patients, but there were no significant differences. The 3-year relapse-free survival rate of the laparoscopic group was significantly higher than that of the open group for stage I patients; there were no differences between the open and laparoscopic groups among the stage II and III patients. In the multivariate analyses, laparoscopic resection was a significant factor in relapse-free survival. Laparoscopic patients had significantly lower blood loss and a significantly longer operative time than the open groups. Also, postoperative hospital stay was significantly shorter and postoperative morbidity was significantly lower in the laparoscopic group. CONCLUSION: Although this retrospective study has limitations, we can conclude that laparoscopic surgery for transverse and descending colon cancer is oncologically safe and yields better short-term results than open surgery.

Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial.

BACKGROUND: Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. METHODS: We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20-75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0-2, and metastasis stage M0; and tumour size of 8 cm or smaller were included. Only accredited surgeons did surgery as an operator or instructor. Patients were randomly assigned (1:1) preoperatively to undergo D3 resection either by an open route or a laparoscopic route, via phone call or fax to the Japan Clinical Oncology Group (JCOG) Data Center. Randomisation used a minimisation method with a biased-coin assignment according to tumour location (caecum, ascending vs sigmoid, rectosigmoid) and institution. The primary endpoint was overall survival and was analysed by intention to treat. The non-inferiority margin for the hazard ratio (HR) was set at 1·366. This study is registered with UMIN Clinical Trials Registry, number C000000105, and ClinicalTrials.gov, number NCT00147134. FINDINGS: Between Oct 1, 2004, and March 27, 2009, 1057 patients were randomly assigned to either open surgery (n=528) or laparoscopic surgery (n=529). 5-year overall survival was 90·4% (95% CI 87·5-92·6) for open surgery and 91·8% (89·1-93·8) for laparoscopic surgery. Laparoscopic D3 surgery was not non-inferior to open surgery for overall survival (HR 1·06, 90% CI 0·79-1·41; pnon-inferiority=0·073). 65 (13%) patients in the open surgery group and 53 (10%) patients in the laparoscopic surgery group had grade 2-4 adverse events. Grade 2-4 adverse events included diarrhoea (15 [3%] in the open surgery group vs 14 [3%] in the laparoscopic surgery group), paralytic ileus (six [1%] vs nine [2%]), and small intestine bowel obstruction (16 [3%] vs 11 [2%]). Two treatment-related deaths occurred in the open surgery group: one patient died 7 days after surgery (probably due to myocardial infarction), and one patient died from febrile neutropenia, pneumonia, diarrhoea, and gastrointestinal haemorrhage during postoperative chemotherapy. INTERPRETATION: Laparoscopic D3 surgery was not non-inferior to open D3 surgery in terms of overall survival for patients with stage II or III colon cancer. However, because overall survival in both groups was similar and better than expected, laparoscopic D3 surgery could be an acceptable treatment option for patients with stage II or III colon cancer. FUNDING: National Cancer Center Research and Development Fund, Grant-in-Aid for Cancer Research, and Health and Labour Sciences Research Grant for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan.