Ross L. Ristagno

Source Control Review in Clinical Trials of Anti-infective Agents in Complicated Intra abdominal Infections

In clinical trials of complicated intra-abdominal infections, assessment of adequacy of the initial surgical approach to the management of the infection is of considerable importance in determining outcome. Antibiotic therapy would not be expected to adequately treat the infection if the surgical procedure was inadequate with respect to source control. Inclusion of such cases in an efficacy analysis of a particular therapeutic antibiotic may confound the results. We analyzed the source control review process used in double-blind clinical trials of antibiotics in complicated intra-abdominal infections identified through systematic review. We searched MEDLINE (PubMed) and ClinicalTrials.gov databases to identify relevant articles reporting results from double-blind clinical trials that used a source control review process. Eight prospective, randomized, double-blind, multicenter, clinical trials of 5 anti-infective agents in complicated intra-abdominal infections used a source control review process. We provide recommendations for an independent, adjudicated source control review process applicable to future clinical trials.

Developing a pediatric endovascular thrombolysis program: a single-center experience

Deep venous thrombosis (DVT) is being increasingly recognized as a significant issue in children. Despite the low incidence of DVT, the risks of pulmonary embolism and death in children are significant. Post-thrombotic syndrome, a syndrome of chronic venous insufficiency, can have long-term adverse consequences in children and adolescents. Adult studies have shown that catheter-directed therapy can reduce the incidence of post-thrombotic syndrome. Safety of catheter-directed therapy in adolescents has also been demonstrated. These reasons compelled us to institute a pediatric endovascular thrombolysis program at our institute for management of pediatric DVT. We describe the process of developing a multi-disciplinary thrombolysis program involving interventional radiology (pediatric and adult), pediatric hematology, critical care, anesthesia and vascular surgery, and describe the role of each specialty in the development of the program. We also describe our experience with patient selection, endovascular therapy procedure, pre-, intra- and post-procedure monitoring, and follow-up management for endovascular therapy for DVT.

Radioembolisation for treatment of pediatric hepatocellular carcinoma

Transarterial radioembolisation with yttrium-90 (TARE-Y90), a catheter-directed therapy, has been used extensively in adults to treat primary and secondary hepatic malignancies. To our knowledge, the use of this palliative technique has not been described in children. We present two children with unresectable hepatocellular carcinoma (HCC) treated with TARE-Y90.

Radiofrequency ablation of a large hepatic adenoma in a child

Hepatic adenomas are rare benign liver tumors seen most commonly in young women on oral contraceptives. Large hepatic adenomas are at risk of malignant transformation and require treatment in select patients, usually by surgical resection. Radiofrequency ablation (RFA) has become a widely used and accepted tool for the curative treatment of small primary hepatocellular carcinomas in adults; however, its use in the treatment of other liver lesions, such as hepatic adenoma, has only recently been described. Use of RFA for liver lesions in pediatric population remains novel. We present a case of large hepatic adenoma successfully treated with RFA in a child with chronic liver disease secondary to alpha-1-antitrypsin deficiency. RFA may be an attractive option in pediatric liver tumor management in selected cases because of its less invasive characteristics.

Diagnosis of occult meat aspiration by fiberoptic bronchoscopy

Cytologic examination of bronchial washings from a patient with a persistent localized pulmonary infiltrate revealed large numbers of striated muscle fibers. The patient died shortly after bronchoscopy, and postmortem examination provided evidence of recurrent aspiration pneumonias. Since skeletal muscle fibers are not likely to enter the tracheobronchial tree from any endogenous source, it is proposed that this unusual cytologic finding is virtually diagnostic of recent food aspiration.

Downstaging therapy followed by liver transplantation for hepatocellular carcinoma beyond Milan criteria

Background. Orthotopic liver transplantation is a curative treatment for hepatocellular carcinoma within Milan criteria, but these criteria preclude many patients from transplant candidacy. Recent studies have demonstrated that downstaging therapy can reduce tumor burden to meet conventional criteria. The present study reports a single‐center experience with tumor downstaging and its effects on post–orthotopic liver transplantation outcomes. Methods. All patients with hepatocellular carcinoma who were evaluated by our multidisciplinary liver services team from 2012 to 2016 were identified (N = 214). Orthotopic liver transplantation candidates presenting outside of Milan criteria at initial radiographic diagnosis and/or an initial alpha‐fetoprotein >400 ng/mL were categorized as at high risk for tumor recurrence and post‐transplant mortality. Results. Of the 214 patients newly diagnosed with hepatocellular carcinoma, 73 (34.1%) eventually underwent orthotopic liver transplantation. The majority of patients who did not undergo orthotopic liver transplantation were deceased or lost to follow‐up (47.5%), with 14 of 141 (9.9%) currently listed for transplantation. Among transplanted patients, 21 of 73 (28.8%) were considered high‐risk candidates. All 21 patients were downstaged to within Milan criteria with an alpha‐fetoprotein <400 ng/mL before orthotopic liver transplantation, through locoregional therapies. Recurrence of hepatocellular carcinoma was higher but acceptable between downstaged high‐risk and traditional candidates (9.5% vs 1.9%; P > .05) at a median follow‐up period of 17 months. Downstaged high‐risk candidates had a similar overall survival compared with those transplanted within Milan criteria (log‐rank P > .05). Conclusions. In highly selected cases, patients with hepatocellular carcinoma outside of traditional criteria for orthotopic liver transplantation may undergo downstaging therapy in a multidisciplinary fashion with excellent post‐transplant outcomes. These data support an aggressive downstaging approach for selected patients who would otherwise be deemed ineligible for transplantation.

Routine use of U-tube drainage for necrotizing pancreatitis: a step toward less morbidity and resource utilization.

BACKGROUND A U-tube drainage catheter (UTDC) is a novel intervention for necrotizing pancreatitis, with multiple benefits: bidirectional flushing, greater interface with large fluid collections, less risk of dislodgement, and creation of a large-diameter fistula tract for potential fistulojejunostomy. We report the first clinical experience with UTDC for necrotizing pancreatitis. METHODS From 2011 to 2014, all patients undergoing UTDC for necrotizing pancreatitis at our institution were identified. Clinical variables including patient, disease, and intervention-specific characteristics as well as long-term outcomes populated our dataset. RESULTS Twenty-two patients underwent UTDC for necrotizing pancreatitis; the median follow-up was 10.2 months. Necrotizing pancreatitis was most commonly owing to gallstones (n = 9; 41%), idiopathic disease (n = 5; 23%), and alcohol abuse (n = 4; 18%). During the course of UTDC and definitive operative therapy (when required), patients had median hospital stays of 31 days, 6 interventional radiology procedures, and 6 CT scans. Operative intervention was not necessary in 9 patients (41%). Among the other 13 patients, 4 patients underwent distal pancreatectomy/splenectomy, 8 had a fistulojejunostomy performed, and 1 underwent both procedures. CONCLUSION UTDC for necrotizing pancreatitis patients is associated with effective drainage and low morbidity/hospital resource utilization. With skilled interventional radiologists and multidisciplinary coordination, this technique is a valuable means of minimizing morbidity for patients with necrotizing pancreatitis.

Radiotracer localization of nonpalpable pulmonary nodules: A single-center experience

Objective Multiple localization techniques to facilitate intraoperative identification of small or nonsolid pulmonary nodules have been developed. Radiotracer localization using technetium‐labeled macroaggregated albumin has been our preferred localization method since 2009. We report our experience, including technical pitfalls and modifications, of our initial 77 patients who underwent this technique. Methods All patients undergoing preoperative radiotracer localization were identified from a prospective database. Medical records were retrospectively reviewed for patient demographic characteristics, nodule characteristics, procedure details, pathologic data, and outcomes. Results Seventy‐seven patients underwent localization of 79 pulmonary nodules. Radiotracer localization had an overall success rate of 95%; however, 2 patients required a second localization procedure on the same day. Most failures occurred in nodules that were < 5 mm from the pleural surface, resulting in pleural spillage. Seventy‐three patients underwent a diagnostic wedge resection, with 2 of these patients requiring 2 wedge resections. In 2 patients, the nodules were successfully localized; however, they were too deep for wedge resection and required anatomic resection. Two patients did not undergo resection. One patient developed pleural spillage and hemothorax and due to subsequent comorbidities, was never rescheduled. The second patient did not tolerate single‐lung ventilation. The majority (86%) of lesions were malignant. Median length of stay was 2 days (range, 1‐15 days). There was no 30‐day mortality. The only morbidity was a prolonged air leak (>5 days) in 5 patients. Conclusions Radiotracer localization is a simple and effective technique for intraoperative identification of small pulmonary nodules.

Sorafenib in hepatocellular carcinoma (HCC): Is there a role for starting patients on a total daily dose of 400mg daily?

364 Background: S at a starting daily dose of 400mg twice daily (800mg) is considered the standard systemic therapy for HCC, in pts with well preserved liver function and advanced stage HCC, based largely on data reported by the SHARP and Asia-pacific trials. Due to complaints regarding SE and reluctance to start at full dose, we decide to retrospectively look at our HCC data base. This single institution retrospective review, evaluated the impact of starting S at a 400mg daily (200mg twice daily). Methods: From 06/01/09-09/01/13, using ICD code 155, newly registered advanced HCC pts, ECOG PS 2, Childs Pugh (CP) class A or B who were started on S 400mg daily were identified : CT scans and AFP levels were followed. PFS was estimated from the date of commencing therapy to date of progression or death if this occurred first and OS was estimated from date of commencing therapy until date of death or loss to follow up. Kaplan Meier survival estimates were obtained with 95% (CI). Log rank test was used to compa...

Percutaneous Cholecystostomy in the Management of Acute Cholecystitis

A 59-year-old man with endstage liver disease, portal hypertension, and suspected hepatocellular carcinoma presented with 3 days of anorexia, right upper quadrant abdominal pain, and nausea. Physical examination revealed right upper quadrant tenderness. The patient was afebrile with a white blood cell count of 6000/cubic millimeter. A contrast-enhanced computed tomography (CT) of the abdomen revealed gallbladder distention, pericholecystic inflammatory stranding, and multiple gallstones (Fig. 1). Ultrasound (US) revealed a thickened gallbladder wall and multiple gallstones (Fig. 2). Based on clinical and imaging findings, acute calculous cholecystitis was diagnosed. Given the patient’s significant comorbid conditions and estimated high risk of general anesthesia, a percutaneous cholecystostomy (PC) tube was placed using US and fluoroscopic guidance in the radiology department. An 8-French locking pigtail catheter was inserted into the gallbladder via the transhepatic approach using intravenous sedation and local anesthesia (Fig. 3). Culture of nonpurulent bile yielded Enterococcus and a-hemolytic streptococcus species. Based on culture results, the patient was started on intravenous piperacillin/ tazobactam. The patient’s nausea and abdominal tenderness resolved within 24 hours after PC tube placement. He was discharged on the fourth hospital day with the cholecystostomy tube to bag drainage, a 14-day course of oral amoxicillin/clavulanate, and scheduled for follow-up in surgery clinic to determine optimal timing of cholecystectomy.