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Background: The potential benefits of robotic-assisted compared with laparoscopic surgery for locally advanced cancer have not been sufficiently proven by prospective studies. One factor is speculated to be the lack of strict surgeon criteria. The aim of this study was to assess outcomes for robotic surgery in patients with locally advanced rectal cancer with strict surgeon experience criteria., Methods: A criterion was set requiring surgeons to have performed more than 40 robotically assisted operations for rectal cancer. Between March 2020 and May 2022, patients with rectal cancer (distance from the anal verge of 12 cm or less, cT2-T4a, cN0-N3, cM0, or cT1-T4a, cN1-N3, cM0) were registered. The primary endpoint was the rate positive circumferential resection margin (CRM) from the pathological specimen. Secondary endpoints were surgical outcomes, pathological results, postoperative complications, and longterm outcomes., Results: Of the 321 registered patients, 303 were analysed, excluding 18 that were ineligible. At diagnosis: stage I (n = 68), stage II (n = 84) and stage III (n = 151). Neoadjuvant therapy was used in 56 patients. There were no conversions to open surgery. The median console time to rectal resection was 170 min, and the median blood loss was 5 ml. Fourteen patients had a positive CRM (4.6%). Grade III-IV postoperative complications were observed in 13 patients (4.3%)., Conclusion: Robotic-assisted surgery is feasible for locally advanced rectal cancer when strict surgeon criteria are used., (© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.)

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%., Competing Interests: J.W. reports receiving honoraria for lectures from Johnson and Johnson K.K., Medtronic, and Eli Lilly and Company, and receiving research funding from Medtronic, AMCO, and TERUMO outside the submitted work. I.T. reports grants from Stryker Japan during the conduct of the study; grants from Intuitive, grants from Medtronic, and grants from Johnson and Johnson outside the submitted work. T.K. reports receiving honoraria for lectures from Chugai Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Takeda Pharmaceutical Company Limited, and Eli Lilly and Company. The remaining authors report no conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: Intensive local treatment comprising total mesorectal excision (TME) with selective lateral pelvic lymph node dissection (LPND) after neoadjuvant chemoradiotherapy (CRT) for locally advanced rectal cancer (LARC) has received attention among clinicians treating rectal cancer. It remains unclear whether adjuvant chemotherapy (ACT) after intensive local treatment is beneficial for these patients. We evaluated the oncologic benefit of ACT for patients with LARC who received intensive local treatment., Materials and Methods: This international multicentre retrospective cohort study included 737 patients treated in Japan and Korea between 2010 and 2017. The effectiveness of ACT on recurrence-free survival (RFS) was evaluated using univariable and multivariable Cox proportional hazards models, with subgroup analyses to identify subpopulations potentially benefiting from ACT., Results: The median follow-up was 49 months; the 5-year RFS and local recurrence rates for the entire cohort were 72.1% and 4.9%, respectively; 514 patients (69.7%) received adjuvant chemotherapy, without an oncologic benefit (hazard ratio, 1.14; 95% confidence interval [CI]: 0.79-1.68) demonstrated in the multivariable Cox regression analysis. In subgroup analyses, the distributions of the 95% CI in patients aged ≥70 years and those with ypStage 0 tended to place a disproportionate emphasis that favoured the non-ACT treatment strategy., Conclusion: Despite achieving good local control with intensive local treatment strategy, the effectiveness of ACT for the LARC patients with CRT followed by TME with selective LPND was not proved. Elderly patients and those with ypStage0 may not receive benefit from ACT after CRT and TME ± LPND., Competing Interests: Declaration of competing interest None., (Copyright © 2022 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Introduction: Total mesorectal excision (TME) and postoperative adjuvant chemotherapy following neoadjuvant chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC). However, neoadjuvant CRT has no recognised impact on reducing distant recurrence, and patients suffer from a long-lasting impairment in quality of life (QOL) associated with TME. Total neoadjuvant therapy (TNT) is an alternative approach that could reduce distant metastases and increase the proportion of patients who could safely undergo non-operative management (NOM). This study is designed to compare two TNT regimens in the context of NOM for selecting a more optimal regimen for patients with LARC., Methods and Analysis: NOMINATE trial is a prospective, multicentre, randomised phase II selection design study. Patients must have clinical stage II or III (T3-T4Nany) LARC with distal location (≤5 cm from the anal verge or for those who are candidates for abdominoperineal resection or intersphincteric resection). Patients will be randomised to either arm A consisting of CRT (50.4 Gy with capecitabine) followed by consolidation chemotherapy (six cycles of CapeOx), or arm B consisting of induction chemotherapy (three cycles of CapeOx plus bevacizumab) followed by CRT and consolidation chemotherapy (three cycles of CapeOx). In the case of clinical complete response (cCR) or near cCR, patients will progress to NOM. Response assessment involves a combination of digital rectal examination, endoscopy and MRI. The primary endpoint is the proportion of patients achieving pathological CR or cCR≥2 years, defined as the absence of local regrowth within 2 years after the start of NOM among eligible patients. Secondary endpoints include the cCR rate, near cCR rate, rate of NOM, overall survival, distant metastasis-free survival, locoregional failure-free survival, time to disease-related treatment failure, TME-free survival, permanent stoma-free survival, safety of the treatment, completion rate of the treatment and QOL. Allowing for a drop-out rate of 10%, 66 patients (33 per arm) from five institutions will be accrued., Ethics and Dissemination: The study protocol was approved by Wakayama Medical University Certified Review Board in December 2020. Trial results will be published in peer-reviewed international journals and on the jRCT website., Trial Registration Number: jRCTs051200121., Competing Interests: Competing interests: KY reports honoraria from Chugai Co., Ltd., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Advanced low rectal cancer has a non-negligible risk of lateral pelvic lymph node (LPLN) metastasis (LPLNM) and lateral local recurrence (LR) after neoadjuvant (chemo)radiotherapy and total mesorectal excision. LPLN dissection (LPLND) reduces LR but increases postoperative complications and sexual/urinary dysfunction., Objective: The aim of this study was to develop a new radiomics-based prediction model for LPLNM in patients with rectal cancer., Methods: A total of 247 patients with rectal cancer and enlarged LPLNs treated by (chemo)radiotherapy and LPLND were enrolled in this retrospective, multicenter study. LPLN radiomic features were extracted from pretreatment portal venous-phase computed tomography images. A radiomics score of LPLN was constructed based on the least absolute shrinkage and selection operator regression in a primary cohort of 175 patients. Model performance was assessed in terms of discrimination, calibration, and decision curve analysis, and was externally validated in 72 patients., Results: The radiomics score showed significantly better discrimination compared with pretreatment short-axis diameter measurements in both the primary (area under the curve [AUC] 0.91 vs. 0.83, p = 0.0015) and validation (AUC 0.90 vs. 0.80, p = 0.0298) cohorts. Decision curve analysis also indicated the superiority of the radiomics score. In a subanalysis of patients with a short-axis diameter ≥ 7 mm, the radiomics nomogram, incorporating the radiomics score and LPLN shrinkage to ≤ 4 mm, had better discrimination compared with a model incorporating only LPLN shrinkage in both cohorts., Conclusions: Radiomics-based prediction modeling provides individualized risk estimation of LPLNM in rectal cancer patients treated with (chemo)radiotherapy, and outperforms measurements of pretreatment LPLN diameter.

Objective: The aim of this study was to investigate the influence of chemoradiotherapy (CRT) on nutritional status and the association between changes in nutritional status and clinical outcomes (treatment completion, adverse events, perioperative complications, and relapse-free survival [RFS]) in patients with locally advanced rectal cancer (LARC)., Methods: In this multicenter, phase II study, 41 patients with LARC underwent CRT for 5 wk, followed by a 6- to 8-wk interval before surgery. Body weight, body mass index (BMI), lean body mass, serum albumin, and prealbumin levels were measured before (pre-), during, and after CRT, and before surgery. Changes in these data and scores on the Malnutrition Universal Screening Tool (MUST) were calculated based on pre-CRT status., Results: Twelve patients (29.3%) experienced body weight loss (BWL) ≥5% (defined as malnutrition) after CRT (P < 0.001) and before surgery (P = 0.035). Significant changes were seen in serum albumin levels and BMI during and after CRT (P < 0.001), and in MUST scores after CRT (P = 0.003) and before surgery (P = 0.035). Treatment completion was significantly associated with BWL (P = 0.028), MUST score (P = 0.013), and decreased serum albumin level (P = 0.001) after CRT. Regarding adverse events, MUST score before surgery (P = 0.009) and serum albumin level after CRT (P = 0.002) were significantly associated with diarrhea severity. Serum albumin level during CRT was associated with the onset of neutropenia (P = 0.005). No association was found between BWL and RFS., Conclusions: These findings suggest that malnutrition and changes in nutritional status are not only commonly observed after CRT, but also associated with treatment completion and adverse events., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Laparoscopic surgery for rectal cancer offers favorable short-term results without compromising long term oncological outcomes so far, according to the data from major trials. For this reason, it is currently considered as a standard option for rectal cancer surgery. The learning curve of laparoscopic rectal cancer surgery is generally longer compared to colon cancer. Appropriate standardization and training of laparoscopic rectal cancer surgery is required. Several RCTs suggested the potential negative effect on quality of resected specimen, which can increase local recurrence. The long-term outcomes - especially local recurrence rate - of these RCTs are awaited. Lateral pelvic lymph node dissection (LPLND) has a certain effect of reducing local recurrence of rectal cancer even after neoadjuvant radiotherapy. Since LPLND is associated with postoperative morbidity, we should carefully select the candidate to maximize the effect of LPLND and minimize the morbidity caused by LPLND. Recent advancements in imaging study such as CT and MRI enable us to find the suitable candidates for LPLND. The morbidity caused by LPLND could be reduced by minimally invasive surgeries such as laparoscopic surgery and robotic surgery. We have to improve oncological outcomes and reduce morbidity by the multidisciplinary strategy for rectal cancer including total mesorectal excision, neoadjuvant chemoradiotherapy and LPLND together with laparoscopic surgery.

Background: The local recurrence of rectal cancer classifies 4 types, anterior, posterior, lateral compartment and anastomotic site. This study evaluates outcome of laparoscopic lateral lymph node dissection(LLND)against the lateral lymph node recurrence., Method: Five patients were diagnosed as the lateral lymph node recurrence and underwent laparoscopic LLND. We diagnosed the lateral lymph node recurrence by CT, MRI and PET-CT. All cases revealed abnormal uptake on PET-CT., Result: The median of age is 63. Three patients are male. About primary tumor, 4 patients had tumor below peritoneal reflection and one patient above it. Two patients received neoadjuvant(chemo)radiotherapy(RT group)and one of them underwent laparoscopic LLND at the first operation. The median period from operation to recurrence was 25 months. Before re-operation, 3 patients received chemotherapy. Pathological assessments confirmed pathological complete response(pCR) in all three cases. The median of operation time and bleeding were 257 min and 0 mL, respectively. No complications, more than Grade III(Clavien-Dindo classification)happened. The median follow-up period from re-operation was 34 months. Four patients have no recurrence and one presents lung metastasis. All 5 patients are alive., Conclusion: Laparoscope magnifies various pelvic structures. Therefore we perform operation more exactly and safety. In the case of local recurrence, especially lateral compartment, tumor is easy to invade adjacent structures. Then, it is often difficult to do R0 resection. If we find the recurrence lesions earlier and induce neoadjuvant chemotherapy, we can improve R0 resection rate.

We present a case of bilateral lymph node metastases of rectal cancer treated with chemotherapy and surgery. The patient was a 65-year-old man with upper rectal cancer. Laparoscopic low anterior resection(LAR)was performed. Pathological findings were tub2>por>muc, pT3, ly2, v3, pN2, pM0. Six months after surgery, the CEA level was elevated. CT and PET-CT confirmed bilateral metastasis to the lymph nodes. Five courses of FOLFOX4 plus bevacizumab were administered, and then, we performed laparoscopic bilateral lymph node dissection. Pathological assessments confirmed scarring and fibrosis, that is, a pathological complete response(pCR)was achieved. Two years and 6 months after surgery, no recurrence was detected. After chemotherapy or chemoradiotherapy, we should perform surgery to prevent local recurrence, especially to the lateral lymph nodes.

A 53-year-old man was readmitted with abdominal distention 2 weeks after undergoing laparoscopic low anterior resection with para-aortic lymphadenectomy for advanced rectal cancer (T4aN1M0, Stage IIIb). Ultrasound revealed massive ascites, and paracentesis revealed chylous fluid with a markedly elevated triglyceride level (1762 mg/dL). Despite conservative management, the fistula remained on postoperative day 120. On percutaneous lymphangiography, the chylous leakage point was clearly visualized at the para-aortic site, and surgical intervention was planned. The abdominal cavity was carefully explored with laparoscopy, and the lymphatic leakage point was detected at the site of previous lymphadenectomy. Leakage was stopped with direct suture ligation and fibrin glue, and the patient was discharged 2 weeks later with no recurrence of the chylous fistula. Surgical intervention can be effective in select patients with a major chylous fistula that persists despite conservative therapy. When the leakage point is localized and detectable on percutaneous lymphangiography, the laparoscopic approach may be feasible., (© 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.)

Aim: In Japan, we have not been able to validate the results of laparoscopic surgery for locally advanced rectal cancer using the universal index "circumferential resection margin (CRM)." Previously, we established a semi‐opened circular specimen processing method and validated its feasibility. In the PRODUCT trial, we aimed to assess CRM in patients with locally advanced rectal cancer who underwent laparoscopic rectal resection. Methods: This was a multicenter, prospective, observational study. Eligible patients had histologically confirmed rectal adenocarcinoma located at or below 12 cm above the anal verge with clinical stage II or III and were scheduled for laparoscopic or robotic surgery. The primary endpoint was pathological CRM. CRM ≤1 mm was defined as positive. Results: A total of 303 patients operated on between August 2018 and January 2020 were included in the primary analysis. The number of patients with clinical stage II and III was 139 and 164, respectively. Upfront surgery was performed for 213 patients and neoadjuvant therapy for 90 patients. The median CRM was 4.0 mm (IQR, 2.1‐8.0 mm), and CRM was positive in 26 cases (8.6%). Univariate and multivariate analyses demonstrated that a predicted CRM from the mesorectal fascia of ≤1 mm on MRI was the significant factor for positive CRM (P =.0012 and P =.0045, respectively). Conclusion: This study showed the quality of laparoscopic rectal resection based on the CRM in Japan. Preoperative MRI is recommended for locally advanced rectal cancer to prevent CRM positivity. [ABSTRACT FROM AUTHOR]