ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer.

BACKGROUND: Ovarian cancer with extensive metastatic disease involving pelvic structures often requires rectosigmoid resection for complete gross resection; however, it is associated with increased surgical morbidity. There are limited data, and none in ovarian cancer, on near-infrared assessment of perfusion in rectosigmoid resections with anastomosis. PRIMARY OBJECTIVE: To compare the rate of pelvic complications (pelvic abscesses, anastomotic leaks, and infections) within 30 days of surgery with and without near-infrared assessment of perfusion at time of rectosigmoid resection and re-anastomosis in patients undergoing cytoreductive surgery for ovarian cancer. STUDY HYPOTHESIS: We hypothesize the use of near-infrared technology (intravenous indocyanine green and endoscopic near-infrared fluorescence imaging), compared with standard intra-operative assessment, to evaluate anastomotic perfusion at time of rectosigmoid resection and re-anastomosis will result in lower rates of post-operative pelvic complications. TRIAL DESIGN: This is a planned multicenter randomized controlled trial. Patients who undergo rectosigmoid resection as part of their ovarian cytoreductive surgery will be randomized 1:1 to standard assessment of anastomosis with the surgeon's usual technique (control arm) or assessment with near-infrared angiography using indocyanine green and endoscopic fluorescence imaging (experimental arm). Randomization will occur after rectosigmoid resection has been completed and the surgeon declares their plan to create a diverting ostomy. Randomization will be stratified by plan for diverting ostomy. MAJOR INCLUSION/EXCLUSION CRITERIA: Main inclusion criteria include patients with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for cytoreductive surgery with suspected need for low-anterior rectosigmoid resection. PRIMARY ENDPOINT: Rate of 30-day post-operative pelvic complications. SAMPLE SIZE: 310 (155 per arm) ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Q2 2027 and Q4 2027, respectively. TRIAL REGISTRATION: NCT04878094.

Trends in Immunotherapy Clinical Trials to Treat Glioblastoma: A Look at Progress and Challenges.

PURPOSE: We aimed to catalog past and present clinical trials on immunotherapy treatments for glioblastoma (GBM) and discover relevant trends in this field. METHODS: Former and ongoing clinical trials involving the use of immunotherapy to treat GBM were queried in July 2022 within the clinicaltrials.gov registry (https://clinicaltrials.gov/). Pertinent trials were categorized by variables including immunotherapy classification, tumor type (newly diagnosed versus recurrent), country of origin, start date, clinical phase, study completion status, estimated subject enrollment, design, publication status, and funding source. RESULTS: A list of 173 trials was identified in total. The number of immunotherapy clinical trials to treat GBM has increased over time. The largest proportion of trials were gene therapies (97 studies; 56.1%) and viral therapies (37 studies; 21.4%). Studies were designated as a biologic (45.1%), drug (43.9%), genetic (2.3%), or procedure (1.2%). Trials spanned 19 countries; China, the second largest contributor (5.8%) after the United States (70.0%), has increased clinical trial development in the past years. The average time to completion was 52.3 months. Trials were primarily funded by academic centers; however, one-fourth of the trials were funded by industry and 2 were funded by foundations. One-t of the trials were active and over one-third were linked to publications. CONCLUSIONS: Our findings provide a comprehensive summary of the state of immunotherapy clinical trials for GBM, highlighting the evolving nature and growing scope of this field.

Isolated Lower Limb Weakness Following Hemorrhagic Stroke: A Case Report.

Isolated limb weakness (monoparesis) has many possible etiologies. Although often assumed to be of a peripheral cause, it can be of central origin. This article describes a case from the Emergency Department of left lower limb weakness in a walk-in male patient on no medications, who had a 50-pack-year smoking history, type II diabetes, and asymptomatic atrial fibrillation. The patient had no history of previous episodes or trauma. His vitals were normal, and his speech and facial function were intact. The patient had full function of his upper limbs, no sensory deficits, and equal reflexes bilaterally. The singular clinical finding was decreased strength in the left leg compared to the right. Imaging revealed a right frontal intraparenchymal hemorrhage, which remained stable throughout his hospital admission. His muscle weakness was significantly improved upon discharge. In general, strokes can present with a variety of symptoms, which increase the risk of misdiagnosis. Monoparesis can be the singular sign of a stroke, and it is more common in the upper than the lower limbs.

Acute abdomen with a parasitic smooth muscle tumor of uncertain malignant potential (STUMP) in pregnancy; a unique case report.

INTRODUCTION AND IMPORTANCE: Diagnosis of a smooth muscle tumor of uncertain malignant potential (STUMP) during pregnancy is rare. Furthermore; the investigation of an intra-abdominal mass during pregnancy is clinically challenging due to anatomical changes and additional considerations of the developing fetus and radiation exposure. The unusual nature and diagnostic dilemma of such a case warrants a case report to serve as an educational prompt to clinicians who may encounter pregnant patients with undifferentiated intra-abdominal masses and/or suspecting of STUMP. CASE PRESENTATION: We report a rare case of a parasitic STUMP diagnosed during pregnancy. The patient presented with a new umbilical hernia and deranged liver function tests (LFT's) during her third trimester. MRI reported a large mass in the left mid flank with intra-abdominal varices extending into the umbilical hernia. She went on to develop an acute abdomen requiring laparotomy where a parasitic fibroid adherent to the omentum was excised and a preterm infant was delivered via caesarean section. Histology was difficult due to pregnancy related changes but ultimately confirmed a diagnosis of STUMP. CLINICAL DISCUSSION: STUMP in pregnancy is rare and diagnosis is further complicated by histological challenges due to pregnancy related changes. Postoperative diagnosis is challenging due to lack of universally accepted diagnostic criteria and Uncertainty regarding prognostic factors makes management and follow-up of patients with STUMP challenging. Studies have shown that younger patients are more likely to demonstrate recurrence. CONCLUSION: Investigation and management of intra-abdominal masses in pregnancy is challenging. It requires timely multi-disciplinary team (MDT) input. Additional complications and considerations relate to the preterm fetus. Knowledge and understanding of these difficulties will better equip clinicians working with such patients to formulate a structured and well informed approach to the pregnant patient with a new intra-abdominal mass. Diagnosis of STUMP during pregnancy may be challenging for the pathologist and require further exert opinion.