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Endoscopic resection, particularly endoscopic submucosal dissection (ESD), for colorectal cancers enables a precise pathological diagnosis and safe R0 resection. The recurrence rate after ESD is generally extremely low, with annual surveillance colonoscopy recommended. However, surveillance may not be considered for super-elderly patients owing to their condition. This is a case report of an 85-year-old man in whom curative resection was achieved for an intramucosal adenocarcinoma with ESD. The patient presented with a hypoechoic mass located in his lower right abdomen, diagnosed via surveillance abdominal ultrasound. He had undergone curative ESD for intramucosal cecal cancer 2 years prior. Colonoscopy revealed a type 2 epithelial tumor at the proximal aspect of the ESD scar. Ileocolic resection with lymph node dissection was performed. An epithelial tumor and well-differentiated adenocarcinoma but not a submucosal tumor was detected in the mucosal layer. The lesion was diagnosed not as a local recurrence after ESD but as a newly emerged original advanced cancer. After ESD for colorectal cancer, a newly developed advanced cancer may occur at the site of the ESD scar in a shorter term than usual. Surveillance colonoscopy after ESD is necessary even for super-elderly patients.

Background Upper gastrointestinal (GI) bleeding is the most important presentation of an aorto-duodenal fistula (ADF). Early diagnosis is difficult, and the disease is associated with high mortality. The present study aimed to examine the clinical and the endoscopic characteristics of ADF in eight patients who presented to our hospital. We also sought to clarify the diagnostic approach towards the disease. Methods The present study examined the clinical and the endoscopic/computed tomography (CT) characteristics of ADF in eight patients who were definitively diagnosed with this condition in a 12-year period at our hospital. Results The patients comprised of five men and three women, with a mean age of 69.8 years. Upper gastrointestinal bleeding was the chief complaint for all the patients. Out of these, two patients presented with shock. The patients’ mean haemoglobin at presentation was 7.09 g/dL, and the mean number of blood transfusions was 7.5. All patients had undergone intervention to manage an aortic pathology in the past. As the first investigation, an upper GI endoscopy in 5 and a CT scan in 3 patients were performed. In cases where CT scan was performed first, no definitive diagnosis was obtained, and the diagnosis was confirmed by performing an upper GI endoscopy. In cases where endoscopy was performed first, definitive diagnosis was made in only one case, and the other cases were confirmed by the CT scan. In some cases, tip attachments, converting to long endoscopes, and marking clips were found useful. Conclusions In patients who have undergone intervention to manage an aortic pathology and have episodes of upper gastrointestinal bleeding, ADF cannot be definitively diagnosed with only one investigation. In addition, when performing upper GI endoscopy in cases where an ADF is suspected, tip attachment, converting to a long endoscope, and using marking clips can be helpful.

Pancreatic pseudocyst and portal vein thrombosis are common conditions resulting from acute and chronic pancreatitis. However, pancreatic pseudocyst-portal vein fistula (PPVF) is a rare and life-threatening complication. In PPVF patients, drainage or operative therapy is necessary under certain conditions, including communication between the pseudocyst and pancreatic duct, pancreatic duct stricture, pancreatic duct stone, and infection that is difficult to control with antibiotics. We describe the case of a 78-year-old woman who presented with an infected pancreatic pseudocyst invading the portal venous system with obstruction due to thromboembolization. Conservative therapy with antibiotics was insufficient. We, therefore, performed endoscopic ultrasound-guided cyst-drainage (EUS-CD). During EUS-CD, PPVF and pseudocyst-pancreatic duct fistula were confirmed by contrast medium injection. Despite the presence of the pseudocyst-pancreatic duct fistula, the pancreatic duct was not visualized in the pancreatic head, suggesting stricture in the main pancreatic duct. We, therefore, performed endoscopic retrograde pancreatography, which revealed pancreatic stone in the main pancreatic duct. Then, we added a 7-Fr pancreatic stent. She was discharged after 89 days of hospitalization. We reviewed the literature on the management of PPVF formation, and EUS-CD is considered to be a good treatment option for PPVF patients without portal vein patency.

Background Bleeding can be a serious adverse event of endoscopic sphincterotomy (EST). However, the risk of EST bleeding between direct oral anticoagulant (DOAC) users and those who received no antithrombotic agents has not been clarified. This study analyzed the risk factors for bleeding after EST in patients on DOAC and evaluated the Japan Gastroenterological Endoscopy Society (JGES) guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. Methods We retrospectively analyzed 524 patients treated with EST who received DOAC or no antithrombotic drug from May 2016 to August 2019. We investigated the risk factors for bleeding. DOAC was typically discontinued for ≤ 1-day based on the JGES guideline. Although DOAC therapy recommenced the next morning after EST in principle, the duration of DOAC cessation and heparin replacement were determined by the attending physician based on each patient’s status. Results The number of patients on DOAC (DOAC group) and those not on antithrombotic drug (no-drug group) was 42 (8.0%) and 482 (92.0%), respectively. DOAC was discontinued for ≤ 1-day in 17 (40.0%) patients and for > 1-day in 25 (60.0%). Of the 524 patients, 21 (4.0%) had EST bleeding. The bleeding rate was higher in the DOAC group (14.0%) (p = 0.004). Multivariate analysis showed that bleeding occurred more frequently in patients on DOAC (odds ratio [OR] 3.95, 95% confidence interval [CI] 1.37–11.4, p = 0.011), patients with low platelet counts (p = 0.001), and elderly patients (> 80 years old) (OR 3.36, 95%CI 1.17–9.65, p = 0.024). Conclusions DOAC treatment, low platelet count, and old age (> 80 years old) are risk factors for EST bleeding. Although the bleeding incidence increased in patients on DOAC who received antithrombotic therapy according to the JGES guidelines, successful hemostasis was achieved with endoscopy in all cases, and no thrombotic events occurred after cessation of DOAC. Thus, the JGES guidelines are acceptable.

Objectives Considering that pathogens resistant to initial antibiotic therapies for cholangitis can affect mortality rates, appropriate initial empiric antibiotic therapy is important. However, evidence regarding the influence of pathogens resistant to initial antibiotics in patients with cholangitis who have undergone early endoscopic retrograde cholangiopancreatography (ERCP) is limited, and the conditions in several cases can improve with early ERCP even when pathogens resistant to initial antibiotics are detected on time. Therefore, this study aimed to assess the influence of pathogens resistant to initial antibiotics on the course of cholangitis in patients undergoing early ERCP. Materials and methods Patients (n=266) with positive blood or bile culture results treated with early ERCP were divided into those with cultures that were resistant to the initial antibiotics (antibiotic-resistant group; n=66; 24.8%) and those with cultures that were sensitive to the initial antibiotics (antibiotic-sensitive group; n=200; 75.2%). The duration of hospitalization, in-hospital mortality rates due to cholangitis, rates of increased disease severity, and complications during hospitalization were studied. Results Enterococcus, Enterobacter, Citrobacter, and Pseudomonas species showed high resistance to several antibiotics. No significant between-group differences were found in the duration of hospitalization, in-hospital mortality rates due to cholangitis, and rates of increased disease severity. However, the rate of post-ERCP cholecystitis was significantly higher in the antibiotic-resistant group than in the antibiotic-sensitive group (p=0.0245). Conclusions Even if the initial antibiotics were ineffective, the rate of fatal outcomes did not increase among patients with cholangitis who had undergone early ERCP. However, when initial antibiotics were ineffective, the frequency of post-ERCP cholecystitis increased even after early bile duct decompression.

A 72-year-old man who had been on continuous ambulatory peritoneal dialysis treatment for 10 years underwent cardiopulmonary bypass for aortic valve replacement due to aortic valve stenosis. After surgery, he experienced pancreatitis, and rupture of a splenic artery aneurysm. He went into cardiopulmonary arrest but was successfully treated by transcatheter arterial embolization (TAE) with cardiopulmonary resuscitation. At three weeks after TAE, CT showed heterogeneous enhancement and the accumulation of pancreatic fluid in the pancreatic tail. At 4 months after TAE, he had sepsis and CT showed greater fluid collection with emphysema in comparison to 3 months previously. We diagnosed infected walled-off necrosis (WON). Conservative therapy with antibiotics was not sufficiently effective; thus, we performed endoscopic ultrasound-guided drainage (EUS-D). Contrast imaging revealed WON with colonic fistula. The WON remarkably decreased in size on CT after EUS-D. We experienced a rare case of ischemic acute pancreatitis (AP) caused by cardiopulmonary bypass complicated with infected WON with a colonic fistula. Ischemic AP more frequently shows a severe course with a fatal outcome in comparison to AP of other causes. However, in our case, ischemic AP with infected WON was successfully treated by EUS-D despite the presence of a WON with a colonic fistula.

We herein report the definitive diagnosis of rectovaginal endometriosis in two cases. Case 1 involved a 46-year-old woman with abdominal pain and hematochezia. The diagnosis after the first and second examinations using lower gastrointestinal (GI) endoscopy was unclear. Differential diagnoses included mucosa-associated lymphoid tissue and colorectal cancer. The third lower GI endoscopy with a targeted biopsy, performed during menstruation, confirmed rectovaginal endometriosis. Case 2 involved a 38-year-old woman with hematochezia. Lower GI endoscopy during menstruation revealed rectovaginal endometriosis. When rectovaginal or bowel endometriosis is suspected, lower GI endoscopy and a targeted biopsy during menstruation can prevent unnecessary surgery.

Background Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalizations for heart failure in patients with or without diabetes. More evidence is needed regarding their effects across the broad spectrum of heart failure, including those with reduced ejection fraction (HFrEF). Methods We randomly assigned, in double-blind fashion, 3730 patients with class II-IV heart failure and left ventricular ejection fraction ≤40% to receive empagliflozin (10 mg once daily) or placebo, in addition to standard therapy for HFrEF. The primary outcome was a composite of cardiovascular death and hospitalization for worsening heart failure. Results Over a median of 16 months, the primary outcome occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio 0.75; 95% CI: 0.65-0.86; P Conclusions Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure, regardless of the presence or absence of diabetes.

SummaryThe therapeutic management of venous thromboembolism (VTE) is rapidly evolving. Following the positive results of pivotal large-scale randomised trials, the non-vitamin K antagonist oral anticoagulants (NOACs) represent an important alternative to standard anticoagulation. In phase III studies, dabigatran was as effective as, and significantly safer than warfarin. Additional information on real-world data of dabigatran is now warranted. RE-COVERY DVT/PE is a multi-centre, international, observational (i. e. non-interventional) study enrolling patients with acute DVT and/or PE within 30 days after objective diagnosis. The study is designed with two phases. Phase 1 has a cross-sectional design, enrolling approximately 6000 patients independently of treatment choice, with the aim of providing a contemporary picture of the management of VTE worldwide. Phase 2 has a prospective cohort design, with follow-up of one year, enrolling 8000 patients treated with dabigatran or vitamin K antagonists (VKAs) with the aim of comparing their safety, defined by the occurrence of major bleeding, and effectiveness, defined by the occurrence of symptomatic recurrent VTE. RE-COVERY DVT/PE will complement both the results of other observational studies in this field and the results of phase III studies with dabigatran, in particular by assessing its clinical benefit in various patient subgroups treated in routine clinical practice.

Results of pharmacometric analyses influence high-level decisions such as clinical trial design, drug approval, and labeling. Key challenges for timely delivery of pharmacometric analyses are the data assembly process and tracking and documenting the modeling process and results. Since clinical efficacy and safety data typically reside in the biostatistics computing area, an integrated computing platform for pharmacometric and biostatistical analyses would be ideal. A case study is presented integrating a pharmacometric modeling platform into an existing statistical computing environment (SCE). The feasibility and specific configurations of running common PK/PD programs such as NONMEM and R inside of the SCE are provided. The case study provides an example of an integrated repository that facilitates efficient data assembly for pharmacometrics analyses. The proposed platform encourages a good pharmacometrics working practice to maintain transparency, traceability, and reproducibility of PK/PD models and associated data in supporting drug development and regulatory decisions.