The safety and efficacy of relebactam/imipenem/cilastatin in Japanese patients with complicated intra-abdominal infection or complicated urinary tract infection: A multicenter, open-label, noncomparative phase 3 study.

INTRODUCTION: Relebactam, a novel class A/C ß-lactamase inhibitor developed as a fixed-dose combination with imipenem/cilastatin, restores imipenem activity against imipenem-nonsusceptible gram-negative pathogens. METHODS: This phase 3, multicenter, open-label, noncomparative study (NCT03293485) evaluated relebactam/imipenem/cilastatin (250 mg/500 mg/500 mg) dosed every 6 h for 5-14 days in Japanese patients with complicated intra-abdominal infections (cIAIs) or complicated urinary tract infections (cUTIs), including those with secondary sepsis. Sepsis was defined as an infection-induced systemic inflammatory response syndrome, with a documented positive blood culture; patients meeting these protocol-defined criteria were evaluated for efficacy against sepsis. RESULTS: Of 83 patients enrolled, 81 patients (cIAI, n = 37; cUTI, n = 44) received ≥1 dose of study treatment. Escherichia coli was the most common baseline pathogen isolated in both patients with cIAI and cUTI. Adverse events (AEs) were reported in 74.1% (n = 60/81) of patients, and drug-related AEs occurred in 18.5% (n = 15/81). The most common AEs were diarrhea and nausea (8.6%). Serious AEs occurred in nine patients, including one death, but none were considered treatment related. The primary efficacy endpoint for patients with cIAI was clinical response at end of treatment (EOT) in the microbiologically evaluable (ME) population, and for patients with cUTI was microbiological response at EOT in the ME population. The proportion of cIAI and cUTI patients achieving favorable responses were 85.7% (n = 24/28) and 100.0% (n = 39/39), respectively. All patients with sepsis (cIAI, n = 1; cUTI, n = 5) achieved a favorable composite clinical and microbiological response at EOT. CONCLUSIONS: A favorable safety and efficacy profile for relebactam/imipenem/cilastatin was observed in Japanese patients with cIAI and cUTI.

[Resection of an Advanced Rectal Gastrointestinal Stromal Tumor Following Neoadjuvant Chemotherapy].

A 66-year-old man was referred to our hospital after being diagnosed with a pelvic tumor. A subsequent transperineal biopsy revealed spindle cells with CD34·c-kit(+). An enhanced computed tomography scan showed a giant rectal-derived tumor in the pelvis. The tumor was pressing on the urinary bladder and the prostate, and appeared to invade the posterior wall ofthese organs. The patient was diagnosed with rectal GIST, and neoadjuvant therapy with 400mg/day imatinib was initiated. Three months later, the tumor reduction rate was at 33.6%, and surgery was performed. The operative method applied was pelvic exenteration and ileal conduit, for local R0 resection. The patient has remained recurrence free for 2.5 years since the surgery.

Robot-assisted laparoscopic partial gastrectomy combined with endoscopy for gastrointestinal stromal tumors with intraluminal growth: a report of two cases.

In cases of gastrointestinal stromal tumor (GIST) with intraluminal growth, determining the minimal resection line is difficult; however, the combined use of endoscopy can overcome this limitation. We performed robot-assisted partial gastrectomy with endoscopy for two cases of internally developed GISTs located on the posterior wall near the esophagogastric junction (EGJ). We confirmed the tumor location and determined minimal surgical margins using endoscopy. The double bipolar method (DBM), which is performed with Maryland bipolar forceps in the right hand and fenestrated bipolar forceps in the left hand, was used to reduce residual gastric damage and prevent tumor damage. The characteristics of robot-assisted surgery made it easier to precisely perform anastomosis of the upper part of the stomach, as compared with laparoscopic surgery, thus minimizing gastric deformity. Both patients were discharged without postoperative complications. In conclusion, robot-assisted partial gastrectomy using the DBM may represent a viable treatment option for gastric submucosal tumors close to the EGJ.

Resection of an icteric type hepatoma with tumor thrombi filling the right posterior bile duct.

A 67-year-old male with jaundice was found to have hepatocellular carcinoma in the right hepatic lobe and tumor thrombi in the common hepatic duct. Physicians initially considered the tumor unresectable, and treated the patient with transcatheter arterial infusion chemotherapy and biliary endoprosthesis. The patient developed a liver abscess after the second transcatheter arterial infusion, and the physicians consulted our department for another form of therapy. Percutaneous transhepatic biliary drainage was performed to relieve revived obstructive jaundice. Cholangiography revealed tumor thrombi extending through the right posterior segmental bile duct into the common hepatic duct. Most biliary branches of the caudate lobe joined with the left lateral posterior segmental branch. Arterial and portal venous branches of the caudate lobe were not involved. Right hepatic lobectomy and extrahepatic bile duct resection were performed 1 year after initial diagnosis. On histologic examination, the epithelium of the right posterior segmental bile duct, which was filled with the tumor thrombi, was not detected. The patient is alive without recurrence 24 months after surgery. Careful investigation of biliary branches of the caudate lobe on cholangiography is essential to determine the necessity of caudate lobectomy in patients with hepatocellular carcinoma and tumor thrombi filling the right posterior segmental bile duct.

Massive mucinous carcinoma of the breast untreated for 6 years.

We report a patient with a massive mucinous carcinoma of the breast that had been untreated for 6 years. A 47-year-old premenopausal woman presented with a large right-breast mass. Although she had noticed a lump in the right breast 6 years previously, she had not sought treatment. The tumor had enlarged gradually and become ulcerated. With a diagnosis of advanced breast cancer with skin invasion, she underwent right mastectomy with a free skin graft. No lymph node metastases or distant metastases were detected. The histologic diagnosis of the tumor was pure mucinous carcinoma of the breast with no component of ordinary invasive ductal cancer. She has been well without evidence of tumor recurrence for 7 years after the surgery. The prognosis for mucinous carcinoma of the breast has been recognized as relatively good. The results in our patient are consistent with the biological behavior of this carcinoma.

Excision of a juxtapapillary duodenal diverticulum causing biliary obstruction: report of three cases.

We report three cases of biliary obstruction caused by a juxtapapillary duodenal diverticulum that were treated by excision of the diverticulum. A 72-year-old man, a 77-year-old woman, and an 81-year-old woman each presented with recurrent obstructive jaundice. Diagnostic imaging revealed a juxtapapillary duodenal diverticulum compressing the common bile duct (CBD). Following cholecystectomy, the diverticulum between the intrapancreatic CBD and pancreatic parenchyma was isolated and excised successfully in each case. The patients have been followed up for 34, 31, and 22 months, respectively. In one patient, choledocholithiasis developed 33 months after the surgery, necessitating endoscopic sphincterotomy. Duodenal diverticulectomy is a useful procedure to relieve biliary obstruction caused by a juxtapapillary duodenal diverticulum. However, it remains unclear whether excision of the diverticulum is preferred to biliodigestive anastomosis from the point of view of long-term prognosis. Subsequent surveillance is necessary.

Esophageal intramural pseudodiverticulosis treated by balloon dilatation: report of a case.

A 72-year-old man presented with a 17-year history of dysphagia, which had gradually become worse in recent months. A barium esophagogram showed stenosis of the upper thoracic esophagus with multiple tiny flask-shaped outpouchings along the region of stenosis. Based on this characteristic appearance, we diagnosed esophageal intramural pseudodiverticulosis. He underwent successful balloon dilatation of the stenosis and his dysphagia resolved. Dynamic esophagography showed improved passage through the esophagus. He has been well and not suffering from dysphagia for 4 years since the balloon dilatation.