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Background Tranexamic acid (TXA) may reduce intraoperative blood loss, but it has not been investigated in pancreaticoduodenectomy (PD). Methods A pragmatic, multicentre, randomized, blinded, placebo-controlled trial was conducted. Adult patients undergoing planned PD for biliary, duodenal, or pancreatic diseases were randomly assigned to TXA or placebo groups. Patients in the TXA group were administered 1 g TXA before incision, followed by a maintenance infusion of 125 mg/h TXA. Patients in the placebo group were administered the same volume of saline as those in the placebo group. The primary outcome was blood loss during PD. The secondary outcomes included perioperative blood transfusions, operating time, morbidity, and mortality. Results Between September 2019 and May 2021, 218 patients were randomly assigned and underwent surgery (108 in the TXA group and 110 in the placebo group). Mean intraoperative blood loss was 659 ml in the TXA group and 701 ml in the placebo group (mean difference −42 ml, 95 per cent c.i. −191 to 106). Of the 218 patients, 202 received the intervention and underwent PD, and the mean blood loss during PD was 667 ml in the TXA group and 744 ml in the placebo group (mean difference −77 ml, 95 per cent c.i. −226 to 72). The secondary outcomes were comparable between the two groups. Conclusion Perioperative TXA use did not reduce blood loss during PD. Registration number jRCTs041190062 (https://jrct.niph.go.jp).

Objectives The treatment for superior mesenteric artery embolism is controversial because of the low prevalence of this disease. This study aimed to examine the treatment options for superior mesenteric artery embolism. Methods We retrospectively reviewed the clinical data of twenty patients with superior mesenteric artery embolisms at the Toyohashi Municipal Hospital from April 2010 to March 2020. Clinical characteristics, findings, treatment and outcomes were evaluated. Results The overall median age of the patients was 80 years old. In 16 cases, the obstructed regions of the superior mesenteric artery were proximal to the ileocecal artery bifurcation. Nine cases had pneumatosis intestinalis. Two patients underwent surgery, twelve patients received endovascular intervention and four patients received heparin treatment. Five patients died in the hospital. A comparative study of the outcomes after endovascular intervention showed that the nonsurvivor group had a significantly higher rate of pneumatosis intestinalis than the survivor group (P = 0.046). The patients that had obstructions proximal to the ileocecal artery bifurcation and the presence of pneumatosis intestinalis had a high mortality rate of 60% after endovascular intervention. Conclusions Determining if there is the presence of pneumatosis intestinalis and finding the obstructed region of the superior mesenteric artery are useful for evaluating the appropriate treatment for superior mesenteric artery embolisms.

Nodal metastasis is a leading attributable factor of poor survival in biliary tract cancer (BTC), and adjuvant chemotherapy targeting this high-risk feature has not been attempted to date. This study aimed to test the efficacy of adjuvant S − 1 for patients with node-positive BTC. This single-arm multicenter phase 2 trial enrolled patients who underwent resection for histologically proven node-positive BTC. In this trial, S − 1 was administered at a dose of 80–120 mg/day on 14 days of a tri-weekly cycle for 6 months. The primary end point of the trial was 3-year overall survival (OS), in which the result would be promising if the 90% confidence interval (CI) surpassed a threshold of 30% (alpha error, 0.1; beta error, 0.2). The secondary end points were relapse-free survival (RFS), feasibility, and toxicity. The trial included 50 patients with perihilar (n = 23) or distal (n = 20) cholangiocarcinoma, or gallbladder cancer (n = 7). The median numbers of positive lymph nodes and examined lymph nodes were respectively 2 and 15. The 3-year OS and RFS were respectively 50% (90% CI, 40.9–59.1%) and 32.0% (95% CI, 19.1–44.9%), with median survival times of 34.6 months (95% CI, 19.3–49.8 months) and 18.4 months (95% CI, 11.9–24.9 months). Although hematologic toxicity often occurred, grades 3 and 4 toxicity were rare. The completion rate of the test therapy was 64%, and the median relative dose intensity was 87.5% (interquartile range, 50–100%). Adjuvant chemotherapy with S − 1 may be promising for patients with node-positive BTC.

219 Background: Epidermal growth factor receptor (EGFR) blockade can effectively shrink tumors in metastatic colorectal cancer (CRC) patients without RAS nor BRAF mutations. However, some patients without RAS nor BRAF mutations in their primary tumors have them in metastatic tumors (heterogeneity). Circulating tumor DNA (ctDNA) can reflect these mutations in metastatic tumors. Here, we evaluated the efficacy of EGFR blockade in patients who had no RAS nor BRAF mutations in their primary tumors, but who had them in ctDNA. Methods: We prospectively enrolled 100 patients with confirmed metastatic CRC without RAS nor BRAF mutations in their primary tumors. Patients were treated with first-line systemic chemotherapy that included EGFR blockade. We obtained ctDNA from each patient before they started chemotherapy, and at the time they acquired resistance. We detected RAS, BRAF (V600E), and PIK3CA mutations using digital polymerase chain reaction. Results: In the ctDNA obtained before starting chemotherapy, RAS, BRAF, and PIK3CA mutations were detected in 10, 4, and 2 of the 100 patients, respectively. No patients had both RAS and BRAF mutations in their ctDNA; however, one patient had both BRAF and PIK3CA mutations. Eighty-nine patients had measurable tumor lesions. Of those, 3 experienced a complete response (CR), 72 had a partial response (PR), 12 had stable disease (SD), and 2 had progressive disease (PD). Of 14 patients who had measurable tumors and RAS or BRAF mutations in the ctDNA, 11 (79%) had a PR and 3 (21%) had SD. Of 75 patients who had measurable tumors and no RAS or BRAF mutations in the ctDNA, 3 (4%) experienced a CR, 61 (81%) had PR, 9 (12%) had SD, and 2 (3%) had PD. Patients with RAS or BRAF mutations and patients with neither mutation had response rates of 79% and 85%, respectively. There was no significant difference. Conclusions: As we previously reported, incidence of RAS and BRAF heterogeneity were 10% and 4%, respectively. Heterogeneity of RAS and BRAF mutations had no effect on the response rate of EGFR blockade as first line chemotherapy. Other possible causes of resistance could be MET or HER-2 amplification, PIK3CA mutation, or ALK fusion. The effect of heterogeneity on the duration of response is of great interest; however, one-third of patients are still undergoing treatment with EGFR blockade. Clinical trial information: 000031177 .

Highlights • We report a jejunal GIST with elevated CA19-9 levels that normalized after resection. • A correlation between GIST and the elevation of CA19-9 has been unknown. • The mechanism might be inflammatory hypersecretion by normal epithelial cells. • Careful interpretation of elevated CA19-9 is mandatory. • The possible surgical procedures should not be limited to a minimally-invasive approach., Introduction A gastrointestinal stromal tumor (GIST) with an elevated serum tumor marker level is very rare. We report a case of jejunal GIST associated with extremely elevated levels of serum carbohydrate antigen 19-9 (CA19-9). Presentation of case A 61-year-old woman was referred to our hospital for examination of an abdominal tumor. Laboratory tests revealed extremely elevated CA19-9 levels (13,498 U/mL). Enhanced abdominal computed tomography demonstrated a well-enhanced, round 40 mm tumor. The patient underwent a jejunectomy and lymph node dissection. Based on the postoperative pathological findings, the tumor was diagnosed as a GIST. Microscopically, a solid region of the resected tumor showed negative staining for CA19-9. The serum CA19-9 level drastically decreased postoperatively. Discussion Increased proliferation of epithelial cells secondary to inflammation and ulceration of epithelia may lead to increased secretion and accumulation of CA19-9, which is consequently released into the blood circulation. Conclusion In cases of GIST, an isolated increase of serum CA19–9 is extremely rare; but they are not necessarily associated with malignant transformation.

BACKGROUND Asplenia, the lack of a spleen, can be congenital and increases susceptibility to severe infections caused by encapsulated bacteria, such as Streptococcus pneumoniae (S. pneumoniae). We report two cases of severe pneumococcal infection in two asplenic family members living in the same household. CASE SUMMARY Patient 1, a 38-year-old man with a history of congenital hepatitis B infection and hypospadias, was brought to our emergency department with complaints of cyanosis, cough, and edema of his limbs. He was clinically diagnosed as hyposplenic with overwhelming pneumococcal sepsis. He was admitted to the intensive care unit and was administered antibiotics and catecholaminergic therapy but died 2 h after admission. Patient 2, a 63-year-old woman with a history of type 2 diabetes, was brought to our emergency department one month after admission of Patient 1. She was diagnosed as asplenic with overwhelming pneumococcal sepsis. History-taking revealed that she was the mother of Patient 1 and the two had lived in the same household. She was admitted to the intensive care unit and was rapidly provided antibiotics and catecholaminergic intervention but died one day after admission. CONCLUSION Pneumococcal bacteremia caused by virulent S. pneumoniae may be transmitted within households. All residents of households where individuals with pneumococcal bacteremia are living should be educated about the risk of transmissibility. Family members of patients with congenital asplenia/hyposplenia, all family members should be examined to assess their splenic function.

Purpose There is no concrete evidence to support the association between the amount of subcutaneous fat area (SFA) in the central venous port-insertion site (precordium) and port-related complications. We aimed to investigate the relationship between SFA in the midclavicular line and postoperative infectious complications in patients undergoing port-insertion surgery. Methods This was a single-institute and historical cohort study of 174 patients who underwent first central venous port implantation surgery for chemotherapy between January 2014 and December 2018. SFA in the midclavicular line was measured using preoperative computed tomography scans. The patients were divided into three groups according to SFA amount tertiles, and we investigated the association of SFA with infectious and all-cause complication events within 1 year. Results Within a median follow-up of 306 days, the patients with intermediate SFA had significantly higher infection-free survival than those with low and high SFA (low vs. intermediate vs. high: 80.4% vs. 97.7% vs. 83.4%, respectively, p=0.034). In contrast, there was no significant difference in the overall complication-free survival among the groups (low vs. intermediate vs. high: 80.4% vs. 88.9% vs. 81.8%, respectively, p=0.29). Low SFA was independently associated with high risk of infectious complications (hazard ratio, 9.45; 95% confidence interval, 1.07–83.22, p=0.043). Conclusion Low SFA in the midclavicular line was an independent risk factor for infectious complications in the chemotherapy setting. This practical indicator can be useful for optimizing patients’ nutritional status and when considering other types of vascular access to support administration of intravenous chemotherapy.

Previous studies have shown that signal intensity variations in the gallbladder wall on magnetic resonance imaging (MRI) are associated with necrosis and fibrosis in the gallbladder of acute cholecystitis (AC). However, the association between MRI findings and operative outcomes remains unclear. We retrospectively identified 321 patients who underwent preoperative magnetic resonance cholangiopancreatography (MRCP) and early laparoscopic cholecystectomy (LC) for AC. Based on the gallbladder wall signal intensity on MRI, these patients were divided into high signal intensity (HSI), intermediate signal intensity (ISI), and low signal intensity (LSI) groups. Comparisons of bailout procedure rates (open conversion and laparoscopic subtotal cholecystectomy) and operating times were performed. The recorded bailout procedure rates were 6.8% (7/103 cases), 26.7% (31/116 cases), and 40.2% (41/102 cases), and the median operating times were 95, 110, and 138 minutes in the HSI, ISI, and LSI groups, respectively (both p < 0.001). During the multivariate analysis, the LSI of the gallbladder wall was an independent predictor of both the bailout procedure (odds ratio [OR] 5.30; 95% CI 2.11–13.30; p < 0.001) and prolonged surgery (≥144 min) (OR 6.10, 95% CI 2.74–13.60, p < 0.001). Preoperative MRCP/MRI assessment could be a novel method for predicting surgical difficulty during LC for AC.

Background The efficacy of widely used povidone–iodine applicators for skin sterilization in abdominal surgery is unclear. The aim of this trial was to evaluate whether sterilization with a povidone–iodine applicator was not inferior to a conventional sterilization method. Methods Patients undergoing elective abdominal surgery were assigned randomly to receive single sterilization with the applicator or conventional sterilization. The primary endpoint was wound infection rate. Secondary endpoints were rate of organ/space surgical‐site infection (SSI), adverse effects of povidone–iodine, amount of povidone–iodine used and total cost of sterilization. Results Of 498 patients eligible for the study between April 2015 and September 2017, 240 were assigned and analysed in the applicator group and 246 in the conventional group. Wound infection was detected in 16 patients (6·7 per cent) in the applicator group and 16 (6·5 per cent) in the conventional group (absolute difference 0·0016 (90 per cent c.i. −0·037 to 0·040) per cent; P = 0·014 for non‐inferiority). There was no difference between the groups in the organ/space SSI rate (11 patients (4·6 per cent) in the applicator group and 16 (6·5 per cent) in the conventional group. Both the amount of povidone–iodine used and the total cost of sterilization were higher in the conventional group than in the applicator group (median 76·7 versus 25 ml respectively, P

Neoadjuvant chemotherapy (NAC) alone for locally advanced rectal cancer (LARC) remains an experimental treatment, and the efficacy in terms of long-term outcome has not been fully elucidated. The N-SOG 03 trial examined the safety and efficacy of neoadjuvant CAPOX and bevacizumab (Bev) without radiotherapy in patients with poor-risk LARC. Thirty-two patients with MRI-defined LARC received neoadjuvant CAPOX and Bev followed by curative resection between 2010 and 2011. The overall survival (OS), progression-free survival (PFS), and local-relapse rate (LRR) were calculated using the Kaplan–Meier method, and the risk factors were evaluated by multivariate analysis using the Cox proportional hazard models. This trial is registered with UMIN, number 000003507. In the entire cohort, the 5-year OS was 81.3%. Because of disease progression during chemotherapy, 3 patients ultimately did not undergo curative surgery. As a result, 29 patients underwent R0/1 resection. Among these 29 patients, the 5-year OS, PFS, and LRR were 89.7%, 72.4% and 13.9%, respectively. In multivariate analysis, cT4b tumor was an independent poor prognostic factor for OS and LRR, and ypT4b tumor and absence of N down-staging were independent poor prognostic factors for PFS. Patients with cT4b tumor were not suitable for NAC alone. However, the long-term outcomes of the other patients were satisfactory, and NAC alone might be an option for treatment of LARC. N down-staging was likely to bring favorable PFS, even in patients with cStage III.

Gastric cancer is the second most common malignancy globally and the third most common cause of cancer-related deaths in Japan. In gastric cancer, benefit of surgical resection of liver metastasis, which was shown in colorectal cancer, is not well established. The present study aimed to examine the feasibility of hepatic resection for liver metastasis of gastric cancer. In this retrospective study, we reviewed the medical records of 10 patients with liver-only metastases of gastric cancer who underwent hepatectomy among 2043 patients with gastric cancer who underwent gastric resection between January and December 2016 at a single institution in Japan. Median 1-, 3-, and 5-year overall survival (OS) rates were 78.0%, 33.3%, and 22.2%, respectively, among 10 patients who underwent hepatic resection. There was a significant difference in OS rates between tumors measuring ≥ 5 cm and

Highlights • Glomus tumors are rare submucosal tumors of the stomach, and they are resembling other gastric submucosal tumors. • Immunohistochemical studies are necessary for the diagnosis of gastric glomus tumor. • We present a case of gastric glomus tumor that was removed by laparoscopy endoscopy cooperative surgery (LECS)., Introduction Gastric glomus tumors are rare submucosal mesenchymal tumors. Because gastric glomus tumors are submucosal tumors and resemble gastrointestinal stromal tumors (GISTs), preoperative diagnosis is difficult. We present a case of gastric glomus tumor that was removed by laparoscopy endoscopy cooperative surgery (LECS). Case presentation A 67-year-old female was taken to the emergency room at our hospital due to epigastric pain. An upper gastrointestinal endoscopy revealed a submucosal tumor (SMT) located in the lesser curvature of the upper body of the stomach. Endoscopic ultrasonography revealed an intraluminal hypoechoic tumor located in the third or fourth layer of the stomach wall. Contrast-enhanced computed tomography (CECT) of the abdomen showed a 20-mm, well-enhanced, intraluminal-type tumor located in the lesser curvature of the upper body of the stomach. Laparoscopy endoscopy cooperative surgery (LECS) was performed. Immunohistochemistry revealed the expression of smooth muscle actin and vimentin, but not of keratin, S-100 protein, C-kit, or CD34. The tumor was finally diagnosed as a gastric glomus tumor. Conclusion Glomus tumors are rare submucosal tumors of the stomach, and they should be considered in the differential diagnosis of gastric submucosal tumors. LECS could be a less invasive and effective method for treatment of gastric glomus tumor.

In Japan, inguinal hernia repair is widely performed with local anesthesia. The objective of this study was to evaluate safety and efficacy of intravenous dexmedetomidine as a sedation agent with local anesthesia in inguinal hernia repair. We performed this randomized, single-blind study for 200 patients who were scheduled to undergo inguinal hernia repair with local anesthesia. Patients were randomly divided into two groups (dexmedetomidine group: Group D, midazolam group: Group M). The primary outcome was to evaluate the safety of intravenous dexmedetomidine. Secondary outcomes were to analyze results of operators’ surveys and patients’ questionnaires and evaluate implementation of conscious sedation. Incidence of respiratory depression was significantly higher in Group M than Group D (p = 0.03). Other adverse events examined did not differ significantly. All three operators’ questionnaires indicated that results were better in Group D than Group M. More than 70% of patients in both groups were satisfied with the surgery. More than 80% of Group D patients and 74% of Group M patients achieved a state of conscious sedation. This study demonstrated that intravenous dexmedetomidine during hernia repair with local anesthesia is safe and the results were satisfactory to both operators and patients.

The aim of this study is to investigate the impact of an aberrant anatomy diagnosed with MR cholangiography on the occurrence of bile duct injury. Although many authors report that aberrant anatomy is a strong risk factor for the occurrence of bile duct injury during cholecystectomy, no reports have examined the incidence of aberrant anatomy and its association as an independent risk factor for bile duct injury while controlling for potential confounding factors. This study involved 1289 patients. All images of MR cholangiography were reviewed and the findings, including the presence of aberrant anatomy, thickening of the gallbladder wall, and cystic duct stones—which may be related to the occurrence of bile duct injury—were recorded. The surgical outcome was compared according to the presence or absence of an aberrant anatomy and the predictive factors for bile duct injury were investigated. Aberrant anatomy was present in 11.2% of cases. The incidence of bile duct injury was significantly higher in patients with aberrant anatomy compared with patients without (3.5% versus 0.3%). By multivariate analysis, the presence of an aberrant anatomy and thickening of the gallbladder wall was an independent predictor for bile duct injury occurrence [odds ratio (OR) =16.56, P = 0.001; OR = 10.96, P = 0.006, respectively]. The presence of an aberrant anatomy and thickening of the gallbladder wall is an independent risk factor for the occurrence of bile duct injury.

Purpose This Phase II trial evaluated the safety and efficacy of neoadjuvant chemotherapy (NAC) with S-1 and oxaliplatin (SOX) plus bevacizumab (Bev) in patients with colorectal liver metastasis (CRLM). Methods Patients with initially resectable CRLM received four cycles of SOX plus Bev as NAC. We adopted the R0 resection rate as the primary endpoint, and the threshold R0 resection rate was set at 80%. Results Between December 2010 and August 2014, 61 patients were enrolled in this study and all started NAC. The completion rate of NAC was 82.0%. Three patients (4.9%) developed severe liver dysfunction caused by NAC and one patient finally decided against resection. Three patients (4.9%) were judged as having progressive disease during or after NAC and did not undergo liver resection. Among 57 patients who underwent liver resection after NAC, three patients were diagnosed with CRLM by pre-treatment imaging modalities and received NAC although a final pathological diagnosis was another malignant disease or benign condition. Finally, 47 of the 54 patients (87.0%) with resected CRLM achieved R0 resection. The pathological complete response rate of the 54 patients was 13.0%, and 31.5% were judged as pathological responders. However, the R0 resection rate of 77.0% in the entire cohort did not meet the endpoint. Conclusions NAC with SOX plus Bev has an acceptable toxicity profile and achieved a satisfactory pathological response. However, accuracy of pre-operative diagnoses and liver dysfunction caused by NAC were serious problems. Easy introduction of NAC for initially resectable CRLM should not be performed.

A 60-year old woman had been hospitalized in a psychiatric hospital for 40 years for schizophrenia. An X-ray was performed when she fell, which showed needles in the abdominal field. After additional examinations and questioning, the patient was diagnosed with needles in the abdominal cavity, which were assumed to have been ingested and to have perforated the GI tract 40 years ago. They were removed by laparoscopic surgery. The needles were found in the omentum and near the left ovary. There were no inflammatory reactions around them. There have been previous reports about the removal of intra-abdominal foreign bodies, but foreign body reaction occurred in most of the reports. Our case had the longest period from ingestion of the foreign bodies to their removal. Laparoscopy and intraoperative fluoroscopy are useful for removing intra-abdominal foreign bodies because of their ability to help discriminate between structures and to navigate in real time.

Highlights • The best approach for resecting epidermoid cysts is still controversial. • We successfully performed laparoscopic resection of an epidermoid cyst. • Laparoscopic resection may be a better option in carefully selected cases. • However, the tumor size and location must also be considered., Introduction The best approach for resecting epidermoid cysts is still controversial. We describe a case of an epidermoid cyst in which laparoscopic resection was performed successfully. Presentation of case 63 × 55-mm well-defined cystic mass was incidentally detected by computed tomography in the presacral cavity of a 50-year-old woman during evaluation for upper abdominal pain. Magnetic resonance imaging showed a cystic tumor with a low signal intensity on T1-weighted images and, high signal on T2-weighted images in the left dorsal side of the rectum. This tumor was diagnosed as a developmental cyst, and laparoscopic resection was performed. Resection of the tumor was performed with negative margins. This tumor was histopathologically diagnosed as an epidermoid cyst. There was no evidence of malignancy, and no postoperative event or signs of recurrence occurred 6 months postoperatively. Discussion In our patient, there was no difficulty in the field of view and forceps operability during laparoscopic surgery. Furthermore, it is possible to perform laparoscopic surgery with minimal damage to the muscles, nerves, and rectum, leading to the preservation of anal function. Conclusion Laparoscopic resection of an epidermoid cyst may be a better option in carefully selected cases with consideration of the tumor size and location.

Introduction The Nathanson liver retractor (N) has been known to cause postoperative transient liver dysfunction (POTLD) in laparoscopic gastrectomy (LG). To reduce the incidence of POTLD, specifically we added to the retractor the use of a disk (N + D) to reduce the localized pressure, and furthermore repositioned the retractor every 30 minutes (N + D TM) to reduce the liver retraction time. Before and after introducing this retractor, we assessed four consecutive retraction procedures. These included the following disk suspension methods (D), N, N + D, and N + D TM. Methods We retrospectively enrolled 85 patients who underwent an LG. In the D, N, N + D, and N + D TM groups, we evaluated the postoperative serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values. Results For the D and N groups, the AST value significantly increased from the immediate post‐operation time point (IPOT) to the third postoperative day (POD3). Additionally, the ALT value increased from IPOT to POD7. In the N + D group, the only decrease was in the ALT value at IPOT compared to the N group. The N + D TM group decreased in both the AST value from IPOT to POD3 and in the ALT value from IPOT to POD7, compared to the N group. Conclusions Our findings demonstrate the importance of reducing both the localized pressure and liver retraction time when using the Nathanson retractor to prevent POTLD during an LG. To make this possible, we successfully introduced the use of both a disk and the repositioning of the retractor at 30 minute intervals.

We previously showed that S-1 after curative resection of colorectal liver metastasis had acceptable toxicity and a high rate of completion of therapy in a prospective phase II trial. We here reported the primary endpoint of disease-free survival (DFS). Between October 2008 and August 2010, 60 patients were eligible for this study and received S-1 for 28 days followed by a 2-week rest period. Treatment was started within 8 weeks after surgery and repeated for eight cycles. Median follow-up was 41 months. Among 60 patients, 45 had solitary metastasis, and the median maximum tumor diameter was 2.6 cm. The 3-year DFS and overall survival were 47.4 and 80.0 %, respectively. Recurrences developed in 31 patients, with the remnant liver the most common site (19 patients). Multivariate analysis showed that positive lymph node metastasis around the primary site (p = 0.013) and early liver metastasis (synchronous disease or metachronous disease within 12 months) (p = 0.041) were independent poor prognostic factors for DFS. Patients having both risk factors had a significantly worse DFS than those without these risk factors (p