Two Cases of a Portal Annular Pancreas in Patients Undergoing Pancreaticoduodenectomy.

Introduction: Portal annular pancreas (PAP) is a congenital anomaly resulting from aberrant fusion of the ventral and dorsal pancreatic buds around the portal vein (PV). PAP was classified into three types by Joseph et al., based on the location of the main pancreatic duct around the PV. The presence of PAP is important for the surgical procedure because it is associated with the postoperative pancreatic fistula. There are no standardized surgical procedures of resection and reconstruction for PAP. Case Presentation: We report 2 cases of subtotal stomach-preserving pancreatoduodenectomy in patients with PAP. One case of PAP was discovered coincidentally intraoperatively, and the other case was diagnosed before surgery. The first case was an 84-year-old male patient who underwent surgery for distal bile duct cancer. PAP was noticed intraoperatively when the uncinate process of the pancreas was detached from behind the PV. The second case was an 84-year-old female patient who also underwent surgery for distal bile duct cancer. We recognized PAP from preoperative computed tomography images. In both cases, the ductal anatomy was consistent with type IIIA PAP, and the dorsal pancreas was resected using a stapling device. During the postoperative period, there was no clinically relevant postoperative pancreatic fistula. Conclusion: PAP is rarely encountered intraoperatively; however, it is important to recognize it before surgery and take it into consideration when deciding upon the procedures for resection and reconstruction.

Screening of natural extracts with anti-norovirus effects and analysis of this mechanism in grape seed extract.

Norovirus (NoV）is a major causative virus of viral gastroenteritis and requires a general disinfection method because it is resistant to common disinfectants such as ethanol and chlorhexidine. This study aimed to find natural extracts as candidates for versatile disinfectant ingredients. The antiviral effect of natural extracts against NoV can be evaluated using the feline calicivirus (FCV）-inactivation test and NoV virus-like particle (NoV-VLP）-binding inhibition test. In this study, screening of natural extracts with anti- NoV effects was performed using these two methods. Of the 63 natural extracts examined, 14 were found to have high FCV-inactivation and NoV-VLP-binding inhibitory effects. In addition, we evaluated the NoV-VLPbinding inhibitory effect of grape seed extract（GSE）containing proanthocyanidins under multiple concentration conditions and treatment times and determined that the binding inhibitory effect of GSE was concentration- and time-dependent. Electron microscopy showed that GSE-treated NoV-VLPs aggregated, distorted, and swelled, suggesting that GSE directly interacts with NoV particles. The results suggest that some natural extracts containing GSE can be used as components of disinfectants against NoV.

Quality of life comparison between esophagogastrostomy and double tract reconstruction for proximal gastrectomy assessed by Postgastrectomy Syndrome Assessment Scale (PGSAS)-45.

Aim: The current study compared the postoperative quality of life (QOL) between the esophagogastrostomy method (PGEG) and double tract method (PGDT) after proximal gastrectomy using the Postgastretomy Syndrome Assessment Scale (PGSAS)-45. Methods: Among the 2364 patients who received the PGSAS-45 questionnaire, 300 PGEG and 172 PGDT cases responded. The main outcomes measures (MOMs) consisted of seven subscales (SS) covering symptoms, meals (amount and quality), ability to work, dissatisfaction with daily life, physical and mental component summary of the 8-Item Short Form Health Survey (SF-8), and change in body weight, and were compared between PGEG and PGDT. Results: Overall, PGDT promoted significantly better constipation SS scores (p < 0.05), whereas PGEG tended to promote better body weight (BW) loss% (p < 0.10). A stratified analysis based on the remnant stomach size revealed that among those with a remnant stomach size of 1/2, PGDT had significantly better constipation and dumping SS scores (p < 0.05) and tended to have better working conditions (p < 0.10) compared to PGEG. Even among those with the remnant stomach size of 2/3, PGDT had significantly better diarrhea SS scores, lesser dissatisfaction with symptoms, and better dissatisfaction with daily life SS scores (p < 0.05) and tended to have better constipation SS scores and lesser dissatisfaction with work (p < 0.10) compared to PGEG. Conclusions: After comparing the QOLs of PGEG and PGDT, the stratified analysis according to remnant stomach sizes of 1/2 and 2/3 revealed that PGDT was relatively superior to PGEG for several MOMs.

Relationship between laparoscopic total gastrectomy-associated postoperative complications and gastric cancer prognosis.

This study aimed to investigate the incidence and prognosis of postoperative complications after laparoscopic total gastrectomy (LTG) for gastric cancer (GC). We retrospectively enrolled 411 patients who underwent curative LTG for GC at seven institutions between January 2004 and December 2018. The patients were divided into two groups, complication group (CG) and non-complication group (non-CG), depending on the presence of serious postoperative complications (Clavien-Dindo grade III [≥ CD IIIa] or higher complications). Short-term outcomes and prognoses were compared between two groups. Serious postoperative complications occurred in 65 (15.8%) patients. No significant difference was observed between the two groups in the median operative time, intraoperative blood loss, number of lymph nodes harvested, or pathological stage; however, the 5-year overall survival (OS; CG 66.4% vs. non-CG 76.8%; p = 0.001), disease-specific survival (DSS; CG 70.1% vs. non-CG 76.2%; p = 0.011), and disease-free survival (CG 70.9% vs. non-CG 80.9%; p = 0.001) were significantly different. The Cox multivariate analysis identified the serious postoperative complications as independent risk factors for 5-year OS (HR 2.143, 95% CI 1.165-3.944, p = 0.014) and DSS (HR 2.467, 95% CI 1.223-4.975, p = 0.011). A significant difference was detected in the median days until postoperative recurrence (CG 223 days vs. non-CG 469 days; p = 0.017) between the two groups. Serious postoperative complications after LTG negatively affected the GC prognosis. Efforts to decrease incidences of serious complications should be made that may help in better prognosis in patients with GC after LTG.

Salmonella contamination and hazard analysis in a storage facility for feed materials in Japan.

AIMS: To reduce Salmonella contamination of animal feeds, Salmonella contamination in a feed materials storage facility was investigated, and hazard analysis was performed to acquire the basic information necessary to establish a control method for Salmonella. The result is that managers of feed materials storage facilities will be able to introduce the Hazard Analysis and Critical Control Point (HACCP) systems to quickly and efficiently. METHODS AND RESULTS: A total of 472 samples, including deposits, adhesions, environment samples and materials, were investigated. The detection rate in the storage facility was 5.1% (24/472) over the three-year investigation period. The serovars of detected Salmonella were Agona, Anatum, Bron (or Agbeni), Chester, Infantis, Mbandaka, Minnesota, Muenster, Sinstorf, Typhimurium, O18:- and O1,3,19:-. As a result of hazard analysis after confirming the multiplication factors and detection rate, important hazards were judged to be the outdoor equipment and dust collector. CONCLUSIONS: The risk of Salmonella contamination in storage facilities was clarified. Important Salmonella hazards in storage facilities are Salmonella-contaminated feed materials, multiplication factors such as rainwater and dew condensation, and Salmonella-accumulated dust in dust collectors for fine-powder recovery. These results suggest that proper control of these hazards could reduce the risk of Salmonella in storage facilities. SIGNIFICANCE AND IMPACT OF THE STUDY: This is the first report describing actual Salmonella contamination conditions and risk assessment using the hazard analysis at a feed materials storage facility in Japan. This study will consider implications for the feed industry because the hazard analysis clarified the sites of Salmonella contamination, the tendency of contamination and the points for implementing control measures in the feed materials storage facility.

Assessment of postoperative common bile duct stones after endoscopic extraction and subsequent cholecystectomy.

BACKGROUND: Common bile duct stones (CBDSs) occasionally cause serious diseases, and endoscopic extraction is the standard procedure for CBDS. To prevent biliary complications, cholecystectomy is recommended for patients who present with gallbladder (GB) stones after endoscopic CBDS extraction. However, CBDS can occasionally recur. To date, the occurrence of CBDS after endoscopic CBDS extraction and subsequent cholecystectomy is not fully understood. Hence, the current study aimed to evaluate the incidence of postoperative CBDSs. METHODS: This retrospective observational study included consecutive patients who underwent postoperative endoscopic retrograde cholangiography after endoscopic CBDS extraction and subsequent cholecystectomy between April 2012 and June 2021 at our institution. After endoscopic CBDS extraction, a biliary plastic stent was inserted to prevent obstructive cholangitis. Endoscopic retrograde cholangiography was performed to evaluate postoperative CBDSs after cholecystectomy until hospital discharge. The outcomes were the incidence of postoperative CBDSs and CBDSs/sludge. Moreover, the predictive factors for postoperative CBDSs were evaluated via univariate and multivariate analyses. RESULTS: Of eligible 204 patients, 52 patients (25.5%) presented with postoperative CBDSs. The incidence rate of CBDS/sludge was 36.8% (n = 75). Based on the univariate analysis, the significant predictive factors for postoperative CBDSs were ≥ 6 CBDSs, presence of cystic duct stones, and ≥ 10 GB stones (P < 0.05). Moreover, male sex and < 60-mm minor axis in GB might be predictive factors (P < 0.10). Based on the multivariate analysis, ≥ 6 CBDSs (odds ratio = 6.65, P < 0.01), presence of cystic duct stones (odds ratio = 4.39, P < 0.01), and ≥ 10 GB stones (odds ratio = 2.55, P = 0.01) were independent predictive factors for postoperative CBDSs. CONCLUSIONS: The incidence of postoperative CBDS was relatively high. Hence, patients with predictive factors for postoperative CBDS must undergo imaging tests or additional endoscopic procedure after cholecystectomy.

Outcomes of laparoscopic total gastrectomy in elderly patients: a propensity score matching analysis.

PURPOSE: This study evaluated the short-term outcomes and prognosis after laparoscopic total gastrectomy (LTG) in elderly patients aged ≥ 80 years in a multicenter retrospective cohort study using propensity score matching. METHODS: We retrospectively enrolled 440 patients who underwent curative LTG for gastric cancer at six institutions between January 2004 and December 2018. Patients were categorized into an elderly patient group (EG; age ≥ 80 years) and non-elderly patient group (non-EG; age < 80 years). Patients were matched using the following propensity score covariates: sex, body mass index, American Society of Anesthesiologists physical status, extent of lymph node dissection, and Japanese Classification of Gastric Carcinoma stage. Short-term outcomes and prognoses were compared. RESULTS: We identified 37 propensity score-matched pairs. The median operative time was significantly shorter, and postoperative stay was longer in the EG. In terms of postoperative outcomes, the rates of all complications were comparable. The median follow-up period of the EG and non-EG was 11.5 (1-106.4) months and 35.7 (1-110.0) months, respectively; there were significant differences in 5-year overall survival between the two groups (EG, 58.5% vs. non-EG, 91.5%; P = 0.031). However, there were no significant differences in 5-year disease-specific survival (EG, 62.1% vs. non-EG, 91.5%; P = 0.068) or 5-year disease-free survival (EG, 52.9% vs. non-EG, 60.8%; P = 0.132). CONCLUSIONS: LTG seems to be safe and feasible in elderly patients. LTG had a limited effect on morbidity, disease recurrence, and survival in elderly patients. Therefore, age should not prevent elderly patients from benefitting from LTG.

A Multicenter Retrospective Study Comparing Surgical Outcomes Between the Overlap Method and Functional Method for Esophagojejunostomy in Laparoscopic Total Gastrectomy: Analysis Using Propensity Score Matching.

BACKGROUND: This study aimed to compare the postoperative outcomes after laparoscopic total gastrectomy (LTG) with esophagojejunostomy (EJS) performed using the overlap method or the functional method in a multicenter retrospective study with propensity score matching. METHODS: We retrospectively enrolled all patients who underwent curative LTG for gastric cancer at 6 institutions between January 2004 and December 2018. Patients were categorized into the overlap group (OG) or functional group (FG) based on the type of anastomosis used in EJS. Patients in the groups were matched using the following propensity score covariates: age, sex, body mass index, American Society of Anesthesiologists physical status, extent of lymph node dissection, and Japanese Classification of Gastric Carcinoma stage. The surgical results and postoperative outcomes were compared. RESULTS: We identified 69 propensity score-matched pairs among 440 patients who underwent LTG. There was no significant between-group difference in the median operative time, intraoperative blood, or number of lymph nodes resected. In terms of postoperative outcomes, the rates of all complications [Clavien-Dindo (CD) classification ≥II; OG 13.0 vs. FG 24.6%, respectively; P=0.082], complications more severe than CD grade III (OG 8.7 vs. FG 18.8%, respectively; P=0.084), and the occurrence of EJS leakage and stenosis more severe than CD grade III (OG 7.3% vs. FG 2.9%, P=0.245; OG 1.5 vs. FG 8.7%, P=0.115, respectively) were comparable. The median follow-up period was 830 days (range, 18 to 3376 d), and there were no differences in overall survival between the 2 groups. CONCLUSIONS: There was no difference in surgical outcomes and overall survival based on the type of anastomosis used for EJS after LTG. Therefore, selection of anastomosis in EJS should be based on each surgeon's preference and experience.

[Case Study:Identification of Microbial Distribution and Contamination Source by PDCA Cycle at a Boiled Noodles Factory].

Boiled noodles are considered to be one of the most perishable foods due to their high moisture content and high water activity. Thus, the hygiene control measures based on HACCP manuals has been recommended in the noodle manufacturing industry. However, there were several cases in which post-packaged products manufactured at the Boiled noodles factory of small-to-medium size company detected a viable cell count higher than their voluntary standards. To identify the source of microbial contamination, an investigation based on the Plan-Do-Check-Act (PDCA) cycle was conducted. The results showed that the bacteria causing the contamination were environmental bacteria. Secondary contamination occurred during the cooling process after sterilization. Airborne environmental bacteria and oxygen may have been introduced into the rinsing and cooling water tank by the strong water flow during the rinsing and cooling process, inducing growth of microorganisms in the cooling water and contaminating the final product. This is a new finding, as such occurrence was not listed in the HACCP manual and should be contributed to plan HACCP system.

The effect of the body mass index on the short-term surgical outcomes of laparoscopic total gastrectomy: A propensity score-matched study.

PURPOSE: This study aimed to evaluate the relationship between the body mass index (BMI) and the short-term outcomes of laparoscopic total gastrectomy (LTG). SUBJECTS AND METHODS: Data of patients who underwent LTG for gastric cancer at six institutions between 2004 and 2018 were retrospectively collected. The patients were classified into three groups: low BMI (<18.5 kg/m2), normal BMI (≥18.5 and <25 kg/m2) and high BMI (≥25 kg/m2). In these patients, clinicopathological variables were analysed using propensity score matching for age, sex, the American Society of Anaesthesiologists physical state, clinical stage, surgical method, D2 lymph node dissection, combined resection of other organs, anastomosis method and jejunal pouch reconstruction. The surgical results and post-operative outcomes were compared among the three groups. RESULTS: A total of 82 patients were matched in the analysis of the low BMI and normal BMI groups. There were no differences in operative time (P = 0.693), blood loss (P = 0.150), post-operative complication (P = 0.762) and post-operative hospital stay (P = 0.448). In the analysis of the normal BMI and high BMI groups, 208 patients were matched. There were also no differences in blood loss (P = 0.377), post-operative complication (P = 0.249) and post-operative hospital stay (P = 0.676). However, the operative time was significantly longer in the high BMI group (P = 0.023). CONCLUSIONS: Despite the association with a longer operative time in the high BMI group, BMI had no significant effect on the surgical outcomes of LTG. LTG could be performed safely regardless of BMI.

Surgically treated gastric melanoma of unknown primary: A case report from a 10-year survivor.

We describe an extremely rare case of simultaneous double melanoma of the stomach with no other obvious primary source. The patient has survived for more than 12 years post-complete gastrectomy. The patient was a woman in her seventies who was referred for anemia by another clinic. Esophagogastroscopy revealed an ulcerated gastric tumor that was diagnosed as a gastrointestinal stromal tumor (GIST) by endoscopic biopsy. She was admitted to our hospital for further examination and treatment. Gastroscopy at our institution revealed two submucosal tumors in the gastric wall. Since no metastatic lesions were detected after systemic exploration, multiple GIST of the stomach was diagnosed, and a total gastrectomy was performed. Malignant melanoma was diagnosed in both lesions by a histopathological study of the resected stomach. The patient's postoperative progress was good, and thorough examination of the skin did not result in the discovery of any systemic neoplastic lesions which could be regarded as the source for the primary tumor. No anticancer treatments were used. The patient has survived, with no recurrence for over ten years postsurgery. Strong evidence is presented in this case for the diagnosis and treatment of gastric malignant melanoma.

[A Case of Urachal Cancer at the Inserted Site of Cystostomy after 23 Years].

A 66-year-old man had bilateral lower limb paralysis 30 years ago owing to traumatic injury of the thoracic spinal cord, and surgery(cystostomy)was performed 23 years ago. He was transferred to our hospital followingtreatment of sepsis owingto a worseningdecubitus. There was a 4 cm sized mucin-producingtumor at the inserted site of cystostomy. We performed tumor resection. Histological examination revealed the tumor to be a mucin-producingwell -differentiated adenocarcinoma. There was no tumor in any other organ. There was a residual tumor at the inserted site, and it was located at the dome of the bladder, which we considered to urachal cancer. Therefore, we performed partial resection of the bladder. Histological examination revealed a well-differentiated adenocarcinoma extendingfrom the urachal epithelium, and thus, it was diagnosed as urachal cancer. This is an extremely rare disease and is the first report from Japan.

Circular versus linear stapling in esophagojejunostomy after laparoscopic total gastrectomy for gastric cancer: a propensity score-matched study.

PURPOSE: We used propensity score matching to compare the complication rates after laparoscopic total gastrectomy (LTG) with esophagojejunostomy (EJS) performed using a circular or a linear stapler. METHODS: We retrospectively enrolled all patients who underwent curative LTG between November 2004 and March 2016. Patients were categorized into the circular and linear groups according to the stapler type used for the subsequent EJS. Patients in the groups were matched using the following propensity score covariates: age, sex, body mass index, American Society of Anesthesiologists physical status, extent of lymph node dissection, and Japanese Classification of Gastric Carcinoma stage. Clinicopathological characteristics and surgical outcomes were compared. RESULTS: We identified 66 propensity score-matched pairs among 379 patients who underwent LTG. There was no significant between-group difference in the median operative time, extent of lymph node dissection, number of lymph nodes resected, rate of conversion to open surgery, or number of surgeries performed by a surgeon certified by the Japanese Society of Endoscopic Surgery. In the circular and linear groups, the rate of all complications (Clavien-Dindo [CD] classification ≥ I; 21 vs. 26%, respectively; p = 0.538), complications more severe than CD grade III (14 vs. 14%, respectively; p = 1.000), and occurrence of EJS leakage and stenosis more severe than CD grade III (5 vs. 2%, p = 0.301; 9 vs. 8%, p = 0.753, respectively) were comparable. CONCLUSIONS: There is no difference in the postoperative complication rate related to the type of stapler used for EJS after LTG.

Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer.

Japanese mortality due to colorectal cancer is on the rise, surpassing 49,000 in 2015. Many new treatment methods have been developed during recent decades. The Japanese Society for Cancer of the Colon and Rectum Guidelines 2016 for the treatment of colorectal cancer (JSCCR Guidelines 2016) were prepared to show standard treatment strategies for colorectal cancer, to eliminate disparities among institutions in terms of treatment, to eliminate unnecessary treatment and insufficient treatment, and to deepen mutual understanding between health-care professionals and patients by making these Guidelines available to the general public. These Guidelines were prepared by consensus reached by the JSCCR Guideline Committee, based on a careful review of the evidence retrieved by literature searches, and in view of the medical health insurance system and actual clinical practice settings in Japan. Therefore, these Guidelines can be used as a tool for treating colorectal cancer in actual clinical practice settings. More specifically, they can be used as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient. As a result of the discussions held by the Guideline Committee, controversial issues were selected as Clinical Questions, and recommendations were made. Each recommendation is accompanied by a classification of the evidence and a classification of recommendation categories based on the consensus reached by the Guideline Committee members. Here we present the English version of the JSCCR Guidelines 2016.

Japanese Society for Cancer of the Colon and Rectum (JSCCR) Guidelines 2016 for the Clinical Practice of Hereditary Colorectal Cancer (Translated Version).

Hereditary colorectal cancer accounts for less than 5% of all colorectal cancer cases. Some of the unique characteristics that are commonly encountered in cases of hereditary colorectal cancer include early age at onset, synchronous/metachronous occurrence of the cancer, and association with multiple cancers in other organs, necessitating different management from sporadic colorectal cancer. While the diagnosis of familial adenomatous polyposis might be easy because usually 100 or more adenomas that develop in the colonic mucosa are in this condition, Lynch syndrome, which is the most commonly associated disease with hereditary colorectal cancer, is often missed in daily medical practice because of its relatively poorly defined clinical characteristics. In addition, the disease concept and diagnostic criteria for Lynch syndrome, which was once called hereditary non-polyposis colorectal cancer, have changed over time with continual research, thereby possibly creating confusion in clinical practice. Under these circumstances, the JSCCR Guideline Committee has developed the "JSCCR Guidelines 2016 for the Clinical Practice of Hereditary Colorectal Cancer (HCRC)," to allow delivery of appropriate medical care in daily practice to patients with familial adenomatous polyposis, Lynch syndrome, or other related diseases. The JSCCR Guidelines 2016 for HCRC were prepared by consensus reached among members of the JSCCR Guideline Committee, based on a careful review of the evidence retrieved from literature searches, and considering the medical health insurance system and actual clinical practice settings in Japan. Herein, we present the English version of the JSCCR Guidelines 2016 for HCRC.

Long-term outcome after laparoscopic gastrectomy: a multicenter retrospective study.

BACKGROUND: Despite its spread and advances, laparoscopic gastrectomy (LG) for advanced gastric cancer (AGC) remains controversial. The aim of this study was to evaluate the oncologic outcomes and to identify the potential risk factors for recurrence and survival after LG in AGC patients. PATIENTS AND METHODS: The medical records of patients who underwent radical LG for histopathologically diagnosed stage IB or more advanced gastric cancer from 2004 to 2012 were collected. The clinicopathologic factors and outcomes were evaluated retrospectively. RESULTS: LG was performed for 300 patients, with a median operative time of 278 min and blood loss of 46 ml. Postoperative morbidity was defined as Clavien-Dindo grades III and IV and occurred in 13 patients (6.3%) in the laparoscopic distal gastrectomy group. The pathologic stage was IB in 109 patients (36.3%), IIA in 77 patients (25.7%), IIB in 48 patients (16.0%), IIIA in 31 patients (10.3%), IIIB in 19 patients (6.3%), and IIIC in 16 patients (5.3%). Median follow-up period was 55.2 months. The 3-year relapse-free survival (RFS) rate was 92.7% for stage IB, 87.0% for IIA, 68.8% for IIB, 64.5% for IIIA, 47.4% for IIIB, and 43.8% for IIIC. The 5-year actual overall survival rate was 91.1% for stage IB, 72.7% for II, and 62.5% for III. Multivariate analysis revealed postoperative complication as an independent risk factor for RFS. CONCLUSION: LG for AGC was feasible and provided comparable oncologic outcomes with those previously reported. Postoperative complications correlated with poor prognosis. Randomized control trials should be conducted to confirm these results of LG for AGC in the general population.

Preplanned safety analysis of the JFMC37-0801 trial: a randomized phase III study of six months versus twelve months of capecitabine as adjuvant chemotherapy for stage III colon cancer.

BACKGROUND: Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis. METHODS: Patients aged 20-79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m2/day on days 1-14 of each 21-day cycle). Treatment exposure and adverse events (AEs) were evaluated. RESULTS: A total of 1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 12-month group than in the 6-month group. HFS was the only grade ≥3 AE to have a significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 46% in the 12-month group. HFS was the most common AE requiring dose reduction and treatment discontinuation. CONCLUSIONS: Twelve months of adjuvant capecitabine demonstrated a higher cumulative incidence of HFS compared to the standard 6-month treatment period, while toxicities after 12 months of capecitabine were clinically acceptable. TRIAL REGISTRATION: UMIN-CTR, UMIN000001367.