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Objectives: The present study aimed to identify patients with locally advanced rectal cancer in whom preoperative radiotherapy (RT) can be omitted. Methods: This study was a retrospective multi-institutional study for patients with pathological stage II and III rectal cancer who underwent surgery without preoperative therapy between January 2008 and December 2012. Clinicopathological factors were examined by univariate and multivariate analyses to clarify independent risk factors of local recurrence (LR). Results: The 5-year cumulative local recurrence rate (LRR) of 815 patients was 11.2%. Independent predictive factors of LR were determined by a multivariate analysis to be a tumor location of

Objective The aim of this study was to evaluate the long-term outcomes that were the secondary endpoints of a RCT of multi-port laparoscopic colectomy (MPC) versus SILC in colon cancer surgery. Summary of background data The actual long-term outcomes, such as the 5-year RFS, OS, and recurrence patterns after surgery, have not been evaluated by a RCT. Methods Patients with histologically proven colon carcinoma located in the cecum, ascending, sigmoid or rectosigmoid colon clinically diagnosed as stage 0-III were eligible for this study. Patients were preoperatively randomized and underwent complete mesocolic excision. The 5-year RFS, OS, and recurrence patterns were analyzed (UMIN-CTR 000007220). Results Between March 1, 2012, and March 31, 2015, a total of 200 patients were randomly assigned to either the MPC arm (n = 100) or SILC arm (n = 100). The median follow-up for all patients was 61.0 months. An intention-to-treat analysis showed that the 5-year RFS was 91.0% [95% confidence interval (CI) 85.1%-96.9%] in the MPC arm and 88.0% (95% CI 82.1%-93.9%) in the SILC arm (hazard ratio: 1.37; 95% CI 0.58-3.24; P = 0.479). The 5-year OS was 95.0% (95% CI 91.1%-98.9%) in the MPC arm and 93.0% (87.1%-98.9%) in the SILC arm (hazard ratio: 1.39; 95% CI 0.44-4.39; P = 0.568). There were no significant differences in the recurrence patterns between the 2 arms. Conclusions Even though the results of the 5-year OS and RFS in this trial were exploratory and underpowered, there were no statistically significant differences between the SILC and MPC arms. SILC may be an acceptable treatment option for select patients with colon cancer.

We reported favorable short-term results of laparoscopic surgery in a randomized study comparing open and laparoscopic surgery for elderly patients with colorectal cancer (CRC). The purpose of this study is to clarify the long-term outcomes of the laparoscopic surgery for elderly patients with CRC. The inclusion criteria were ≥ 75 years, adenocarcinoma, ≤ T4a, M0 and elective surgery. The patients were randomly allocated to open or laparoscopic surgery according to the tumor location. The survival rates, recurrence and reasons for death were compared. One hundred patients (right colon 43, left colon 28, rectum 29) were included in each group. Eight patients who underwent open surgery and 2 patients who underwent laparoscopic surgery were excluded from the analysis because of metastatic diseases and other malignancies found during the operations. One hundred ninety patients (98 open, 98 laparoscopic) were analyzed. There was no difference in the backgrounds excluding more patients with vascular invasion in the laparoscopic rectal cancer. There were no differences in the 5-year overall survival rate (open vs. laparoscopic; 78.9% vs. 82.1%, p = 0.638), 5-year disease-free survival rate (70.5% vs. 62.8%, p = 0.276), 5-year recurrence-free survival rate (76.1% vs. 72.1%, p = 0.419), or 5-year cancer-specific survival rate (86.1% vs. 80.5%, p = 0.208). No differences in survival were detected in the analyses of stage and tumor location. There was no significant difference in the overall recurrence rate or recurrence site. However, distant lymph node metastases and local recurrences were more common after laparoscopic surgery than after open surgery. There was no difference in the cause of death. More than half of the patients died from other diseases in both groups (57.9% vs. 52.6%, p = 0.765). Laparoscopic surgery showed similar long-term results compared to open surgery in elderly patients with CRC. Laparoscopic surgery is an effective surgical procedure for elderly patients with CRC.

Lateral lymph node dissection (LLND) has been considered as the standard treatment strategy for locally advanced lower rectal cancer in Japan. Controversy remains around whether all patients require LLND. This study aims to examine the long-term outcomes of patients in which LLND was performed and clarify the value of LLND. Consecutive 458 patients with lower rectal cancer who underwent total mesorectal excision (TME) plus LLND from 1992 to 2012 were included. The long-term outcomes and risk factors for recurrent in patients performed TME + LLND were examined. We assessed the impact of LLND on survival using an estimated therapeutic index. The incidence of LLNM was 15.5%. The 5-year RFS and OS rates of patients with LLNM were 40.9% and 47.7%, while patients without LLNM had a good prognosis. The 5-year local recurrence (LR) rate was 9.2%, and independent risk factors for LR were T4 and LLNM. The LR rate of patients with LLNM was high (22.8%). The LLNM rate of the groups with 0, 1, 2, 3, or 4 risk factors (male, tumor location < 4 cm from anal verge, T4, and MLNM) was 3.8%, 9.2%, 18.1%, and 50.0%. The 5-year OS of the groups was 96.2%, 86.1%, 69.7%, and 48.5%. Although patients with locally advanced lower rectal cancer who received LLND had a good prognosis, LLND alone was insufficient to control local recurrence in patients with metastatic lateral nodes.

Background Obstructive colorectal cancer is locally advanced colorectal cancer with a poor prognosis. The effect of neoadjuvant chemotherapy for obstructive colon cancer is unclear. Objective We conducted the first prospective clinical trial of neoadjuvant chemotherapy for patients with obstructive colon cancer. Methods We conducted a single arm, multicenter trial involving patients from the Yokohama Clinical Oncology Group with obstructive colon cancer. All eligible patients underwent diverting stoma formation before neoadjuvant chemotherapy. Patient received six cycles of mFOLFOX6 followed by primary tumor surgery and then six cycles of adjuvant chemotherapy. The primary endpoint was the objective response rate (ORR) of all intended neoadjuvant therapy. The study was registered with the Japanese Clinical Trials Registry as UMIN000013198. Results Between April 2014, and July 2016, 50 patients were registered, and 46 received neoadjuvant chemotherapy. The ORR as the primary endpoint was 67.4%. The most common grade ≥3 adverse event associated with neoadjuvant chemotherapy was neutropenia (28.3%). Forty-five patients underwent surgical resection of the primary lesion (R0 resection in all cases). Grade ≥2 surgery-related complications occurred in 7 patients (15.6%). The downstaging rate was 48.9%, and the moderate or greater regression rate was 52.2%; no cases showed pathological complete response. Adjuvant chemotherapy with mFOLFOX6 was performed in 34 patients (75.6%). The 3-year relapse-free and overall survival rates were 76.5% and 95.4%, respectively. Conclusion Neoadjuvant chemotherapy using mFOLFOX6 was feasible and might be a treatment option for patients with obstructive colon cancer. Further large-scale studies are warranted to confirm the present findings.

Although the effectiveness of antiemetic therapy for colorectal cancer chemotherapy has improved with further drug development, some patients still suffer from chemotherapy-induced nausea and vomiting (CINV) even with only 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. The present study investigated the risk factors of CINV in patients who received chemotherapy for colorectal cancer and clarified which patients need additional neurokinin 1 receptor antagonist. Patients with colorectal cancer receiving moderate-emetic-risk chemotherapy (MEC) were enrolled in this prospective single-arm study with intravenous palonosetron 0.75 mg and dexamethasone 9.9 mg before chemotherapy and with paroral dexamethasone 8 mg on days 2 and 3. The primary endpoint was the complete response (CR) rate for delayed-phase CINV. A total of 179 patients were eligible for this study. The delayed CR rate was 84.9% (152/179). There were no significant differences in any risk factors, but women with a low body mass index (BMI) (a combination of “female sex” and “BMI < 20”) showed a significantly lower rate of CC (complete control) (odds ratio [OR] = 0.45, 95% confidence interval [CI] = 0.17–1.13; p = 0.039), and young patients with a low BMI (combination of “age < 65” and “BMI < 20”) showed a significantly lower rate of CR (OR = 0.34, 95% CI = 0.13–0.88; p = 0.022) than the other patients. This study failed to identify any single risk factors associated with delayed CINV in patients who received chemotherapy for advanced colorectal cancer. However, combinations of “thin and women” or “young and thin patients” might be possible predictive conditions, thus, candidates for NK1 receptor antagonist administration in MEC. Further investigations are required to develop criteria for the supplementation of NK1 receptor antagonist.

The present study evaluated the safety and efficacy of neoadjuvant chemotherapy with modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus panitumumab in clinical stage III rectal cancer with KRAS wild-type. We conducted a prospective multicenter phase II trial. KRAS wild-type clinical stage III rectal cancer patients were enrolled. Patients received 6 cycles of mFOLFOX6 with 6 mg/kg panitumumab as neoadjuvant chemotherapy. The primary outcome was the response rate (RR) defined by RECIST. Lateral lymph node dissection (LLDN) was performed when patients had a locally advanced tumor

Incisional hernia (IH) is a common complication after colorectal surgery. However, the risk factors for incisional hernia after laparoscopic colorectal surgery (LCRS) have not been fully elucidated. This retrospective study analyzed the incidence rate of IH and evaluated the risk factors for IH after LCRS. This was a retrospective multi-institution study of 423 colorectal cancer patients conducted between September 2012 and December 2014 in Yokohama Clinical Oncology Group. The diagnosis of IH was based on computed tomography and physical examination findings. The patient-, tumor-, and surgery-related variables were examined by univariate and multivariate analyses. A total of 423 patients were analyzed. The median follow-up period was 48.4 months. IH was observed in 36 patients (8.5%). The 1-year incidence of IH was 5.2%, and the 4-year incidence was 8.5%. A multivariate analysis showed that preoperative umbilical hernia (odds ratio [OR] 5.71; 95% confidence interval [CI] 2.02–16.10; p = 0.001) and a visceral fat area (VFA) ≥ 100 cm2 (OR 2.74; 95% CI 1.08–6.96; p = 0.035) were independent risk factors of IH after LCRS. The risk factors of IH after LCRS were preoperative umbilical hernia and VFA ≥ 100 cm2. In the case with an umbilical hernia or VFA ≥ 100 performing LCRS, it should likely NOT have a peri-umbilical extraction site and should be considered for an alternate site like a low transverse or Pfannenstiel incision. Clinical Trials Registration: The trial was registered with the UMIN Clinical Trials Registry, number 000038707.

The short-term results of single-incision laparoscopic colectomy (SILC) showed the safety, feasibility, and effectiveness when performed by skilled laparoscopic surgeons. However, the long-term complications, such as SILC-associated incisional hernia, have not been evaluated. The aim of this study was to determine the incidence of incisional hernia after SILC compared with multi-port laparoscopic colectomy (MPC) for colon cancer. From March 2012, to March 2015, a total of 200 patients were enrolled in this study. The patients were randomized to the MPC arm and SILC arm. A total of 200 patients (MPC arm; 100 patients, SILC arm; 100 patients) were therefore analyzed. In all cases the specimen was extracted through the umbilical port, which was extended according to the size of the specimen. A diagnosis of incisional hernia was made either based on a physical examination or computed tomography. The baseline factors were well balanced between the arms. The median follow-up period was 42.4 (range 9.4–70.0) months. Twenty-one patients were diagnosed with incisional hernia, giving an incidence rate of 12.1% in the MPC arm and 9.0% in the SILC arm at 36 months (P = 0.451). In the multivariate analysis, the body mass index (≥ 25 kg/m2) (hazard ratio [HR] 3.03; 95% confidence interval [CI] 1.03–8.92; P = 0.044), umbilical incision (≥ 5.0 cm) (HR 3.22; 95% CI 1.16–8.93; P = 0.025), and history of umbilical hernia (HR 3.16; 95% CI 1.02–9.77; P = 0.045) were shown to be correlated with incisional hernia. We found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up. However, this result may be biased because all specimens were harvested through the umbilical port. The study was registered with the Japanese Clinical Trials Registry as UMIN000007220.

We report a case of laparoscopic gastrectomy for gastric cancer with an anomalous celiac trunk categorized as Type Ⅵ- Group 24 in the Adachi classification. Upper gastrointestinal endoscopy in an 81-year-old male revealed a shallow depressed lesion in the middle of the gastric body. Close examination led to diagnosis of cT1bN0M0, cStage Ⅰ gastric cancer, and laparoscopic distal gastrectomy was planned. Contrast-enhanced CT revealed no anomalous bifurcation of the hepatic artery, but the common hepatic artery ran on the dorsal side of the portal vein, branching from the superior mesenteric artery. Therefore, an Adachi Type Ⅵ-Group 24 celiac trunk anomaly was diagnosed. During surgery, the common hepatic artery could not be confirmed in guiding suprapancreatic lymph node dissection, and the portal vein was exposed. Anterior to the portal vein, nerves that are usually around the common hepatic artery continuously ran toward the hepatoduodenal ligament instead. Suprapancreatic lymph nodes were dissected, with the portal vein considered as the common hepatic artery. Adachi Type Ⅵ is a rare anomaly with an incidence of about 2%. Preoperative diagnosis enables safe and appropriate lymph node dissection.

The aim of this retrospective study was to evaluate the frequency and risk factors of urinary dysfunction after autonomic nerve-preserving surgery for rectal cancer. This was a retrospective multiinstitution study of 1002 rectal cancer patients conducted between January 2008 and December 2012 in Yokohama Clinical Oncology Group. Patients who had preoperative urinary dysfunction or had not undergone autonomic nerve preservation surgery were excluded. Urinary dysfunction was defined as that with a Clavien-Dindo classification grade ≥ 2. Patient-, tumor-, and surgery-related variables were examined by univariate and multivariate analyses. A total of 887 patients were analyzed. Postoperative urinary dysfunction was observed in 77 patients (8.8%). A multivariate logistic analysis showed that a tumor location in lower rectum (odds ratio [OR] 2.16; 95% confidence interval [CI] 1.15–3.71; p = 0.02), tumor diameter ≥ 40 mm (OR 2.07; 95% CI 1.19–4.44; p

We conducted a prospective study to evaluate the efficacy and safety of postoperative enoxaparin for the prevention of venous thromboembolism (VTE) after laparoscopic surgery for colorectal cancer (LAC) in Japanese patients. The subjects of this multicenter, open-label randomized-controlled trial were 121 patients who underwent LAC between September 2015 and May 2017. The patients were randomly allocated to receive intermittent pneumatic compression (IPC) with enoxaparin (20 mg, twice daily), started 24–36 h after surgery and continued until discharge (Enoxaparin group; n = 61), or IPC alone (IPC group; n = 60). The primary endpoint was the incidence of VTE on day 28 after surgery. The safety outcome was the incidence of any bleeding during treatment and follow-up. The incidence of VTE on day 28 after surgery was 12.3% (7/57 patients) in the enoxaparin group and 11.9% (7/59 patients) in the IPC group ((p = 1.00). One of the 57 patients (1.8%) in the enoxaparin group and none in the IPC group experienced a bleeding event. It may be unnecessary to give enoxaparin to all Japanese patients for the prevention of VTE after LAC. The UMIN Clinical Trials Registry number was UMIN000018633.

Para-aortic lymph node (PALN) metastasis of colorectal cancer is rare, and the treatment strategy for PALN metastasis (PALNM) is not established in contrast to liver or lung metastases. We sought to evaluate the survival outcomes and prognostic factors among patients undergoing surgery combined with extended lymphadenectomy for PALNM from left-sided colorectal cancer. From 1992 to 2012, 322 patients who underwent PALN dissection (PALND) synchronously with primary resection, among 1819 left-sided colorectal surgical cases, were retrospectively examined. We investigated the overall survival (OS) and prognostic factors for patients with PALNM. Of the 322 patients, 62 (19.3%) were histologically confirmed to have PALNM. The 5-year OS in patients with and without PALNM was 19.5% and 67.0% (p

Recent studies have shown the potential benefit of indocyanine green fluorescence imaging (ICG-FI) in lowering the anastomotic leakage (AL) rates by changing the surgical plan. The aim of this study was to evaluate the effect of ICG-FI on the AL rates in laparoscopic low anterior resection (LAR) for rectal cancer. From September 2014 to December 2017, data from patients who underwent laparoscopic LAR for rectal cancer were collected and analyzed. The primary endpoint was the AL rate within 30 days after surgery. The incidence of AL in patients who underwent ICG (ICG-FI group) was compared with that in patients who did not undergo ICG (non-ICG-FI group) using propensity score matching. Data from 550 patients were collected from 3 institutions. A total of 211 patients were matched in both groups by the propensity score. ICG-FI shifted the point of the proximal colon transection line toward the oral side in 12 patients (5.7%). The AL rates of Clavien–Dindo (CD) grade ≥ II and ≥ III were 10.4% (22/211) and 9.5% (20/211) in the non-ICG-FI group and 4.7% (10/211) and 2.8% (6/211) in the ICG-FI group, respectively. ICG-FI significantly reduced the AL rate of CD grade ≥ II and ≥ III (odds ratio (OR) 0.427; 95% confidence interval (CI) 0.197–0.926; p = 0.042 and OR 0.280; CI 0.110–0.711; p = 0.007, respectively). The rate of reoperation was significantly lower (OR 0.192; CI 0.042–0.889; p = 0.036) and the postoperative hospital stay significantly shorter (mean difference 2.62 days; CI 0.96–4.28; p = 0.002) in the ICG-FI group than in the non-ICG-FI group. ICG-FI was associated with significantly lower odds of AL in laparoscopic LAR for rectal cancer. The study was registered with the Japanese Clinical Trials Registry as UMIN000032654.

Background Mesorectal excision (ME) is the standard surgical procedure for lower rectal cancer. However, in Japan, total or tumor-specific ME with lateral pelvic lymph node dissection (LLND) is the standard surgical procedure for patients with clinical stages II or III lower rectal cancer, because lateral pelvic lymph node metastasis occasionally occurs in these patients. The aim of study was to elucidate the predictive factors of pathological lateral pelvic lymph node metastasis in patients without clinical lateral pelvic lymph node metastasis. Methods Data form the clinical trial (JCOG0212) was analyzed. The JCOG0212 was a randomized controlled trial to confirm the non-inferiority of mesorectal excision alone to mesorectal excision with lateral lymph node dissection for clinical stage II/III patients who don't have clinical lateral pelvic lymph node metastasis in terms of relapse free survival. This study was conducted at a multitude of institution33 major hospitals in Japan. Among the 351 patients who underwent lateral lymph node dissection in the JCOG0212 study, 328 patients were included in this study. Associations between pathological lateral pelvic lymph node metastasis and preoperative and postoperative factors were investigated. The preoperative factors were age, sex, clinical stage, tumor location, distance from anal verge, tumor size, and short-axis diameter of lateral pelvic lymph node on computed tomography and the postoperative factors were pathological T, pathological N, and histological grade. Results Among the 328 patients, 24 (7.3%) had pathological lateral pelvic lymph node metastasis. In multivariable analysis of the preoperative factors, patient age (p = 0.067), tumor location (p = 0.025), and short-axis diameter of lateral pelvic lymph node (p = 0.002) were significantly associated with pathological lateral pelvic lymph node metastasis. Conclusions Patient age, tumor location, and short-axis diameter of lateral pelvic lymph node were predictive factors of pathological lateral pelvic lymph node metastasis.

Background Surgical site infection (SSI) is a common morbidity in patients undergoing colorectal surgery, and the focus of previous studies has primarily been on incisional SSI. Most reports thus far have focused on open surgery rather than on laparoscopic colorectal surgery (Lap CR). Therefore, the aim of the present study was to identify the risk factors for incisional SSI in patients undergoing elective Lap CR. Methods This retrospective study was conducted to evaluate the occurrence and risk factors of incisional SSI for elective Lap CR. From January 2008 to June 2018, 1825 consecutive patients with a preoperative diagnosis of colorectal cancer who underwent Lap CR were analyzed at a single institution. Results Incidence of incisional SSI was 3.3%. Postoperative hospital stay (days) was significantly longer in the incisional SSI group than in the non‐incisional SSI group (8 [6‐12] vs 10 [8‐19], P

Background/aim The purpose of this study was to reveal the safety and efficacy of additional surgical resection (ASR) for high-risk T1 colorectal cancer (CRC) after endoscopic resection (ER). Patients and methods We retrospectively analyzed 191 patients with high-risk T1 CRC after ER. Results The ASR was performed in 176 (92.1%) patients and 15 (7.9%) rejected ASR. All patients that underwent ASR experienced R0 resection; laparoscopic surgery was performed in 159 (90.3%) patients. Clavien-Dindo complications ≥grade II occurred in 33 patients (18.8%). Anastomotic leakage (8.5%) and ileus (5.7%) were the most frequent complications. The anus function was preserved in all patients. Metastatic lymph node was detected in 21 (11.9%) patients. There were no deaths or relapses in patients with ASR. One patient without ASR (6.7%) had a lymph node recurrence. Conclusion ASR was safe and effective and is recommended for high-risk T1 CRC patients after ER. A satisfactory long-term outcome can be achieved.

This study aimed to examine the risk factors for surgical site infection (SSI) and the association of that with recurrence in JCOG0212. The results for secondary endpoints showed that compared with the mesorectal excision (ME) alone group, ME with lateral lymph node dissection (LLND) group showed significantly longer operative time and significantly higher blood loss. These results suggested that LLND was a risk factor for SSI. All 701 patients registered in JCOG0212 were analyzed in this study. Wound infection was defined as incisional/deep SSI, and pelvic abscess and anastomotic leakage were defined as organ/space SSI. The risk factors for the incidence of SSI and the effect of SSI on relapse-free survival (RFS) were investigated. Multivariable odds ratio of Grade 2 or higher all SSI was 0.58 [95% Confidence interval: 0.36–0.93] for female (vs. male) and that of Grade 2 or higher incisional/deep SSI was 2.24 [1.03–4.86] for blood infusion. For RFS, patients with Grade 3 or higher all SSI showed poor prognosis (multivariable hazard ratio: 1.66 [1.03–2.68]). LLND is not significant factor for the incidence of all SSI. Male sex might be a risk factor of Grade 2 or higher SSI, and blood transfusion is a possible risk factor of Grade 2 or higher incisional/deep SSI. Grade 3 or higher all SSI might be a significant worse prognostic factor for lower rectal cancer.

This study evaluated the results of laparoscopic surgery (LAP) compared to open surgery (OP) for locally advanced mid-to-lower rectal cancer. From February 2008 to December 2014, we collected patient data with clinical stage II/III mid-to-lower rectal cancer who underwent resection with LAP or OP at 13 institutions associated with the Yokohama Clinical Oncology Group (YCOG). The short-term outcomes and long-term prognoses associated with LAP and OP were analyzed after adjusting for the patients’ backgrounds using propensity score matching. Among 1091 eligible cases, a propensity score matching with six covariates—age, sex, body mass index, American Society of Anesthesiologists physical status category, tumor location, and clinical stage—extracted 237 cases each for the LAP and OP groups, respectively. After matching, there were no differences in background factors between the two groups except for the presence or absence of preoperative treatment. Operative time was significantly longer in the LAP group than that in the OP group (p < 0.001), while the amount of bleeding and the length of postoperative hospital stay were significantly lower in the LAP group than that in the OP group (p < 0.001 and p = 0.001, respectively). There were no significant differences between groups in the incidence of postoperative complications. The 3-year overall survival and relapse-free survival rates were 90.5% and 88.6% and 78.3% and 71.6% in the LAP and OP groups, respectively, which did not differ significantly. The short-term outcomes and long-term prognoses of LAP in this cohort study indicated that LAP could be a therapeutic option for locally advanced rectal cancer. Trial Registration: UMIN000040406

In addition to the direct power of anticancer drugs, the effectiveness of anticancer therapy depends on the host immune function. The present study investigated whether or not the reduction rate and histological response of preoperative chemotherapy were related to the immune microenvironment surrounding a primary tumor of the rectum. Sixty-five patients received preoperative chemotherapy followed by resection from 2012 to 2014; all of these patients were retrospectively analyzed. CD3, CD8, and FoxP3 were immunohistochemically examined as markers for T lymphocytes, cytotoxic T lymphocytes, and regulatory T lymphocytes (Treg), respectively. The correlation between the tumor-infiltrating lymphocyte composition and the tumor reduction rate and histological response to neoadjuvant chemotherapy was investigated. The average tumor reduction rate was 41.5% ± 18.8%. According to RECIST, 47 patients (72.3%) achieved a partial response (PR), and 1 patient (1.5%) achieved a complete response (CR). Eight patients (12.3%) showed a grade 2 histological response, and 2 (3.1%) showed a grade 3 response. A multivariate analysis demonstrated that a low Treg infiltration in stromal cell areas was significantly associated with the achievement of a PR or CR [odds ratio (OR) 7.69; 95% confidence interval (CI) 1.96–33.33; p

The objective of the current study was to assess the therapeutic benefit of lymphadenectomy according to the extent of lymphadenectomy. Patients undergoing colectomy for right‐sided colon cancer were identified. Distribution of lymph node metastases (DLNM) of 1, 2 and 3 were defined as lymph node metastasis (LNM) in the pericolic nodes, the intermediate nodes and the front of the SMV near the origin of the major artery, respectively. The therapeutic index (TI) was calculated based on the frequency of LNM and the 5 year overall survival (OS) rate of patients with LNM. Among 344 patients who met the inclusion criteria, roughly half had LNM (n = 150, 43.7%). While 107 (31.1%) and 30 (8.7%) patients had DLNM1 and DLNM2, respectively, only 13 patients (3.8%) were defined as DLNM3. However, there was no significant difference in 5 year OS by DLNM (DLNM1 71.1%, DLNM2 78.7%, DLNM3 50.4%, p = 0.61). Overall, the TI of lymphadenectomy for D3 area was approximately 1/10 of the TI for D1 (1.9 vs.22.1), given the low frequency of LNM (3.8%) and poor 5 year OS of patients with LNM (50.4%). This trend was consistent irrespective of primary tumor locations. The survival benefit from central lymphadenectomy namely D3 was low among patients with right‐sided colon cancers.

There are few reports on large-scale trials for the long-term outcomes regarding laparoscopic lateral lymph node dissection (LLND). We evaluated the short- and long-term outcomes of laparoscopic versus open LLND for locally advanced middle/lower rectal cancer using a propensity score-matched analysis. From January 2005 to December 2016, consecutive clinical stage II to III middle/lower rectal cancer patients who underwent total mesorectal excision (TME) plus LLND were retrospectively collected at three institutions. Laparoscopic LLND was compared with open LLND for the surgical and oncological outcomes, including the long-term survival, using a propensity score-matched analysis. A total of 325 patients were collected. There were 142 patients who underwent open TME plus LLND (open group) and 183 patients who underwent laparoscopic TME plus LLND (laparoscopic group). A total of 93 patients each were matched to each group. Compared to the open group, the laparoscopic group had a significantly longer operative time (327 vs. 377 min; p = 0.002) but significantly less blood loss (540 vs. 50 ml; p

The short-term results of single-incision laparoscopic colectomy (SILC) showed the safety, feasibility, and effectiveness when performed by skilled laparoscopic surgeons. However, the long-term complications, such as SILC-associated incisional hernia, have not been evaluated. The aim of this study was to determine the incidence of incisional hernia after SILC compared with multi-port laparoscopic colectomy (MPC) for colon cancer.From March 2012, to March 2015, a total of 200 patients were enrolled in this study. The patients were randomized to the MPC arm and SILC arm. A total of 200 patients (MPC arm; 100 patients, SILC arm; 100 patients) were therefore analyzed. In all cases the specimen was extracted through the umbilical port, which was extended according to the size of the specimen. A diagnosis of incisional hernia was made either based on a physical examination or computed tomography.The baseline factors were well balanced between the arms. The median follow-up period was 42.4 (range 9.4-70.0) months. Twenty-one patients were diagnosed with incisional hernia, giving an incidence rate of 12.1% in the MPC arm and 9.0% in the SILC arm at 36 months (P = 0.451). In the multivariate analysis, the body mass index (≥ 25 kg/mWe found no significant difference in the incidence of incisional hernia after SILC arm versus MPC arm with a long-term follow-up. However, this result may be biased because all specimens were harvested through the umbilical port. The study was registered with the Japanese Clinical Trials Registry as UMIN000007220.

In rectal anterior resection, a clear consensus regarding the optimal level of inferior mesenteric artery (IMA) ligation does not exist because of a lack of randomized trials. We conducted a randomized trial to determine if the IMA should be tied at the origin (high tie, HT) or distal to the left colic artery (low tie, LT) (HTLT study). This study is a subanalysis of HTLT study for laparoscopic surgery. All candidates were randomly divided into the HT or LT groups. The lymph node dissection around the origin of the IMA was performed in the LT group. The stratified factor was the approach (open or laparoscopy). Evaluation parameters were operative factors, short-term and long-term results. In the present study, laparoscopic surgeries were examined as subgroup analysis. From June 2006 to September 2012, 331 patients were registered. Two hundred and fifteen patients (107 for HT: 108 for LT) underwent laparoscopic surgeries. There was no difference between the groups in background. The incidence of anastomotic leakage (HT: LT %) showed no significant differences for grade 2 or higher (11.2:9.3), and grade 3 or higher (2.8:4.6). There were no differences in operative time (200:205 min), blood loss (15:15 ml), number of dissected lymph nodes (22:20), and postoperative hospital stay (10:10 days). The incidence of bowel obstruction in HT was significant (3.7 vs. 0%, p = 0.043). There were no significant differences in overall survival (5-year: 91.3 vs. 90.2%, p = 0.850) and disease-free survival (5-year: 83.2 vs. 78.0%, p = 0.525). There were no differences in the first recurrent site and death reason between both groups. The risk factors for leakage were being male and an anastomotic level in a multivariate analysis by logistic regression. The IMA ligation level was unrelated to anastomotic leakage. No significant difference was detected in long-term results between HT and LT.

Background: This trial was designed to verify the superiority of 6 months of postoperative adjuvant chemotherapy with SOX (S-1 with oxaliplatin) with UFT (tegafur and uracil) with LV (leucovorin) in terms of disease-free survival in patients with high-risk stage III colon cancer. We report the results of a planned safety analysis., Pathients and Methods: Patients who underwent curative resection for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries) were randomly assigned to receive either UFT/LV (300-600 mg/d UFT with 75 mg/d LV on days 1-28, every 35 days, for 5 cycles) or SOX (100 mg/m² of oxaliplatin on day 1 with 80-120 mg/d S-1 on days 1-14, every 21 days, for 8 cycles). Treatment status and safety were evaluated., Results: A total of 966 patients were enrolled, and 932 patients were included in safety analyses. The planned 6-month protocol treatment was received by 76.9% of the patients in the UFT/LV group and 65.8% of those in the SOX group. The overall incidence of any Grade adverse events (AEs) were 91.3% in the UFT/LV group and 98.7% in the SOX group, and those of Grade ≥ 3 AEs were 16.1% and 36.1%, respectively. As for Grade ≥ 3 AEs, leukopenia, neutropenia, thrombocytopenia, and sensory neuropathy were more common in the SOX group. The incidence of Grade ≥ 3 sensory peripheral neuropathy was 4.6% in the SOX group., Conclusion: The completion rate of adjuvant SOX and its incidence of AEs were acceptable in patients with colon cancer.

Postoperative urinary dysfunction is a major complication of rectal cancer surgery. A randomized controlled trial (JCOG0212) concluded that the noninferiority of mesorectal excision alone to mesorectal excision with lateral lymph node dissection was not confirmed in terms of relapse-free survival.Eligibility criteria included histologically proven clinical stage II/III rectal cancer, a main lesion located in the rectum with the lower margin below the peritoneal reflection, and the absence of lateral lymph node enlargement. After confirming R0 resection by mesorectal excision, patients were randomized intraoperatively. The residual urine volume was measured three times. Urinary dysfunction was defined as ≥50 mL residual urine occurring at least once or no measurement of residual urinary volume. This trial was registered with the UMIN Clinical Trials Registry, number C000000034.In the mesorectal excision alone and the mesorectal excision with lateral lymph node dissection groups, the incidence of early urinary dysfunction were 58% and 59%, respectively. A tumor location in the lower rectum (vs. upper rectum) and a blood loss of ≥500 mL (vs.500 mL) were associated with an increased risk of early urinary dysfunction. However, only blood loss was independently predictive of early urinary dysfunction (relative risk, 1.25 [95% CI: 1.10-1.55], p = .04).Mesorectal excision with lateral lymph node dissection is not associated with a significant increase in the incidence of urinary dysfunction. Urinary dysfunction is associated with tumor location and blood loss.

Objective:The aim of the study was to confirm the noninferiority of mesorectal excision (ME) alone to ME with lateral lymph node dissection (LLND) in terms of efficacy.Background:Lateral pelvic lymph node metastasis is occasionally found in clinical stage II or III lower rectal cancer, and ME with L

Laparoscopic surgery has been widely accepted for the treatment of colorectal cancer; however, long-term outcomes in elderly patients remain controversial. The midterm results of a randomized trial comparing open surgery with laparoscopic surgery in elderly patients with colorectal cancer are presented. This was a randomized trial comparing open surgery with laparoscopic surgery in elderly patients with colorectal cancer. The primary outcome was complication rate, and secondary outcomes included 3-year recurrence-free survival and overall survival. A total of 200 patients were randomly assigned to open surgery or laparoscopic surgery between 2008 and 2012. The main study objective was to compare the midterm outcomes of open surgery with those of laparoscopic surgery in elderly patients with colorectal cancer. This trial is registered with Clinical Trials.gov (NCT01862562). There were no differences between the laparoscopic surgery group and open surgery group in the 3-year overall survival rate (91.5% for laparoscopic surgery vs. 90.6% for open surgery, p = 0.638) or the 3-year recurrence-free survival rate (84.8% for laparoscopic surgery vs. 88.2% for open surgery, p = 0.324). The local recurrence rate was significantly higher in the laparoscopic surgery group than in the open surgery group in rectal cancer (13.8% for laparoscopic surgery vs. 0% for open surgery, p = 0.038). In subgroup analysis according to tumor location, there were no significant differences in the 3-year overall survival rate or 3-year recurrence-free survival rate between the two treatment groups. The midterm outcomes of laparoscopic surgery are similar to those of open surgery in elderly patients with colorectal cancer.

My arguments regarding postmastectomy radiotherapy (PMRT) for this case are based on the following 4 reasons: (1) high rate of local recurrence in the no PMRT group in the Early Breast Cancer Trialists' Collaborative Group meta-analysis on which the present guideline is based, (2) stage migration by sentinel node biopsy, (3) possible adverse events of radiotherapy, and (4) problems on extrapolation of data from western countries.

Background We conducted a randomized controlled trial (JCOG0212) to determine whether the outcome of mesorectal excision (ME) alone for rectal cancer is not inferior to that of ME with lateral lymph node dissection (LLND). The present study focused on male sexual dysfunction after surgery. Methodology Eligibility criteria included clinical stage II/III rectal cancer, the lower margin of the lesion below the peritoneal reflection, the absence of lateral pelvic lymph node enlargement, and no preoperative radiotherapy. After confirmation of R0 resection by ME, patients were intraoperatively randomized. Questionnaires using the International Index of Erectile Function (IIEF-5) about the sexual function of men were collected before and 1 year after surgery. Sexual dysfunction incidence was defined as the ratio of patients showing sexual dysfunction after surgery relative to the number who had no erectile dysfunction before surgery. Results Among 701 patients enrolled between June 2003 and August 2010, 472 males were included. Among them, 343 (73%) completed preoperative and postoperative questionnaires. According to the study protocol, the incidences of sexual dysfunction in patients who underwent ME alone and ME with LLND were 68% (17/25; 95%CI, 47–85%) and 79% (23/29; 95%CI, 60–92%), respectively (p = 0.37). Incidences of sexual dysfunction in patients with no or only mild erectile dysfunction before surgery who underwent ME alone and ME with LLND were 59% (48/81) and 71% (67/95), respectively (p = 0.15). Multivariate analysis identified age as the only risk factor for sexual dysfunction after surgery (p = 0.02). Conclusions LLND may not increase sexual dysfunction incidence after rectal cancer surgery. This incidence is associated with increased age. This trial is registered with ClinicalTrials.gov , number NCT00190541 and University Hospital Medical Information Network Clinical Trials Registry, number C000000034.

Eppikajututo (TJ-28, a Kampo medicine) is effective against rheumatoid arthritis and eczema. We conducted a randomized comparative trial to assess the efficacy of TJ-28 for preventing hand-foot syndrome (HFS) as a complication of adjuvant chemotherapy using capecitabine. The present study was a multi-institutional randomized-controlled trial (UMIN000005899). Colorectal cancer patients scheduled to receive capecitabine chemotherapy as adjuvant therapy were randomly assigned to receive TJ-28 (7500 mg/day) or oral pyridoxine (60 mg/day). Patients were monitored for the development of grade ≥ 2 HFS according to the National Cancer Institute Common Toxicity Criteria until chemotherapy completion. Twenty-two patients were enrolled in this study. The relative dose intensity of capecitabine was 76.2% in the TJ-28 group and 68.2% in the pyridoxine group. Grade ≥ 2 HFS developed in 6 (50.0%) of 12 TJ-28 patients and in 4 (40.0%) of 10 pyridoxine patients. Chemotherapy treatment failure was observed in seven patients, mainly due to HFS, liver dysfunction, diarrhea, and neutropenia. Chemotherapy treatment failure due to HFS occurred in none of the TJ-28 group and 2 patients (20.0%) in the pyridoxine group (p = 0.114). Capecitabine-associated HFS was not markedly prevented by TJ-28 compared with pyridoxine. However, TJ-28 might support the continuation of chemotherapy with capecitabine. Further studies are warranted to clarify the benefits of TJ-28.

The safety and efficacy of laparoscopic surgery for transverse and descending colon cancer remain controversial. This study aimed to evaluate the short- and long-term outcomes of this procedure. We conducted a single-institutional randomized controlled trial. Patients with transverse or descending colon cancer were randomly allocated to receive laparoscopic surgery (LAC) or conventional open surgery (OC). The primary endpoint was the overall complication rate between the two groups. The secondary endpoints were the length of the postoperative hospital stay, the health-related quality of life (HRQOL) score (at 1, 6, and 12 months after surgery), the 5-year relapse-free survival (RFS), and the 5-year overall survival (OS). Between August 2008 and October 2012, a total of 66 patients were enrolled (33 in the LAC group and 33 in the OC group). The patient characteristics showed no significant differences between the two groups. The complication rates (≥ grade 3) were 6.1% in the LAC group and 12.1% in the OC group (p = 0.392). The length of postoperative stay was not significantly different between the two groups. Regarding the HRQOL, the physical functioning, role physical, bodily pain, social functioning, mental health, and role component summary at 1 month after surgery and the social functioning and mental health at 6 months after surgery were better in the LAC group than in the OC group. The 5-year RFS and OS rates were similar between the LAC and OC groups (RFS 90.5% and 87.3%, respectively, p = 0.752; OS 93.3% and 100.0%, respectively, p = 0.543). The short- and long-term outcomes of laparoscopic surgery for transverse and descending colon cancer are almost equal to those of open surgery. Laparoscopic resection is a better choice than open surgery for managing this cancer with regard to the short- and mid-term QOL. ClinicalTrials.gov Identifier: NCT01861691 .

Performing routine prophylactic cholecystectomy during gastrectomy in gastric cancer patients has been controversial. The frequency of cholelithiasis, cholecystitis, and cholangitis after gastrectomy has not been reported for large patient populations, so we carried out this retrospective study to aid the assessment of the necessity for prophylactic cholecystectomy.This retrospective study reviewed 969 patients with gastric cancer who underwent distal gastrectomies with Billroth I reconstructions (DG) or total gastrectomies with Roux-en-Y reconstructions (TG), preserving the gallbladder, between January 2000 and May 2012. Risk factors for cholelithiasis, cholecystitis, and cholangitis after gastrectomy were evaluated using logistic regression analysis.The median follow-up period after gastrectomy was 48 months (range 12-159 months). After gastrectomy, cholelithiasis occurred in 6.1% (59/969) patients and cholecystitis and/or cholangitis occurred in 1.2% (12/969) patients. The method used for gastrectomy was an independent risk factor for both cholelithiasis (TG/DG: OR (95%CI): 1.900 (1.114-3.240), p = 0.018) and cholecystitis and/or cholangitis (TG/DG: OR (95%CI): 8.325 (1.814-38.197), p = 0.006). In patients who developed cholelithiasis, the incidence of cholecystitis and/or cholangitis was 31.3% (10/32) after TG, but only 7.4% after DG.Prophylactic cholecystectomy may be unnecessary in distal gastrectomy with Billroth I reconstruction.

The aim of this study was to evaluate the long-term prognosis of patients who underwent colectomy for familial adenomatous polyposis. The clinical data of 29 familial adenomatous polyposis patients who underwent colectomy were retrospectively reviewed. Five patients died of causes that included colorectal cancer (CRC), desmoid tumor, cancer of the small intestine, and pancreatitis. The 30-year survival rate was 72%. Among the 15 patients who had CRC at primary surgery, the 5-year survival rate was 100% in stages 0, I, and II, and 75% in stage IIIA. Stage I desmoid tumor showed slow or no growth, whereas a stage IV tumor showed rapid growth and was fatal. Extracolonic malignancies were seen in the small intestine, stomach, duodenum, thyroid, kidney, breast, and ovary. Among 8 patients with ileorectal anastomosis, 4 had a second primary rectal cancer and 6 had a salvage reoperation. None of the patients who underwent either stapled or handsewn ileal pouch–anal anastomosis had second primary rectal cancers. The stage of primary CRC at colectomy is the most important prognostic factor. But in addition to second primary CRC, the management of desmoid tumors and extracolonic malignancies is important for long-term survival regardless of the anastomotic technique used.

This study seeks to evaluate lateral pelvic lymph node (LPLN) and perirectal lymph node (PRLN) status on magnetic resonance imaging (MRI) as potential risk factors for lymph node metastasis. The subjects were 394 patients with lower rectal cancer who underwent MRI prior to mesorectal excision (combined with lateral pelvic lymph node dissection in 272 patients) at 6 institutes. No patients received neoadjuvant therapy. Cases were classified as cN(+) and cN(−) based on the short axis of the largest lymph node ≥5 and