Miyuki Sone

Phase I/II clinical study of percutaneous vertebroplasty (PVP) as palliation for painful malignant vertebral compression fractures (PMVCF): JIVROSG-0202

BACKGROUND The safety and efficacy of percutaneous vertebroplasty (PVP), a new treatment modality for painful malignant vertebral compression fractures (PMVCF) using interventional radiology techniques, were evaluated prospectively. MATERIALS AND METHODS After confirming the absence of safety issues in phase 1, a total of 33 cases were registered up to and including phase 2. Safety and efficacy were evaluated by National Cancer Institute-Common Toxicity Criteria version 2 and Visual Analogue Scale (VAS) at 1 week after PVP. Based on VAS score decreases, efficacy was classified into significantly effective (SE; > or = 5 or reached 0-2), moderately effective (ME; 2-4), or ineffective (NE; <2 or increase). RESULTS Procedures were completed in all 33 patients (42 vertebrae). Thirty days after PVP, two patients died of primary disease progression, but no major adverse reactions (>grade 2) were observed. Response rate was 70% (95% confidence interval 54% to 83%) [61% (n = 20) with SE, 9% (n = 3) with ME, and 30% (n = 10) with NE] and increased to 83% at week 4. Median time to response was 1 day (mean 2.4). Median pain-mitigated survival period was 73 days. CONCLUSION For PMVCF, PVP is a safe and effective treatment modality with immediate onset of action.

Balloon-occluded retrograde transvenous obliteration for gastric varices: the relationship between the clinical outcome and gastrorenal shunt occlusion

BackgroundThe rupture of gastric varices is associated with high mortality rate. Balloon-occluded retrograde transvenous obliteration (B-RTO), a minimally invasive procedure that was introduced in the mid-1990s, has been widely accepted in Japan. Several reports have indicated that B-RTO yields satisfactory results; however, few reports have discussed the recurrence of gastric varices after this therapy. The purpose of this study is to retrospectively evaluate the technical aspects of B-RTO and the recurrence of gastric varices after treatment with this procedure.MethodsB-RTO was performed in 47 patients with gastric varices, who were at a risk of variceal ruptures and who may or may not have had a history of variceal bleeding. We injected a sclerosing agent into the gastric varices for 30-60 minutes. To evaluate the therapeutic efficacy of the technique, we obtained contrast-enhanced computed tomography (CT) scans 5 days after B-RTO. As a general rule, if the gastric varices did not appear thrombosed, we repeated the procedure 7 days after the first procedure.ResultsB-RTO was a technical success in 37 patients. It was performed once in 26 patients, twice in 6 patients, thrice in 2 patients, and 4 times in 3 patients. Contrast-enhanced CT scans obtained after B-RTO showed thrombosed gastrorenal shunts in 29 patients and patent gastrorenal shunts in 8 patients. The gastric varices recurred in 2 patients who had patent gastrorenal shunts. The overall cumulative relapse-free rate of gastric varices was 90% at 5 years after B-RTO.ConclusionsB-RTO is an effective treatment modality for gastric varices. Moreover, obliteration of the gastrorenal shunt as well as the gastric varices appears to be important for the treatment of gastric varices.

Phase I/II multiinstitutional study of uterine artery embolization with gelatin sponge for symptomatic uterine leiomyomata: Japan Interventional Radiology in Oncology Study Group study.

PURPOSE This multicenter prospective study was conducted to evaluate the safety and the efficacy of uterine artery embolization (UAE) with gelatin sponge for symptomatic leiomyomas. MATERIALS AND METHODS Patients with symptomatic uterine leiomyomas were enrolled and treated with UAE. In phase I, nine patients were evaluated for safety. In phase II, 24 patients were accrued, and an intent-to-treat analysis was performed on all 33 patients. The primary endpoint was safety. Secondary endpoints included technical success, hospital stay, change in symptoms, leiomyoma volume on magnetic resonance (MR) imaging, and incidence of treatment failure. RESULTS UAE procedures were performed for all 33 patients. Two patients were lost to follow-up at 3 and 12 months. The median follow-up period was 33.4 months. Minor adverse events (AEs) occurred in 10 patients (33%); major AEs of permanent amenorrhea and leiomyoma expulsion occurred in two (6%). The most common AE was transient amenorrhea. Technical success was achieved in all patients. The median hospital stay was 5 days. At 12 months after UAE, menorrhagia had improved in 90% of patients, pelvic pain in 78%, and bulk-related symptoms in 97%. The mean reduction in leiomyoma volume on MR imaging at 12 months was 61%. Treatment failure occurred in one patient, who underwent hysterectomy for recurrent menorrhagia at 21 months. CONCLUSIONS UAE with gelatin sponge is safe, with efficacy comparable to other embolic agents based on published data. Gelatin sponge should be an option for UAE, but a prospective comparison versus other standard UAE embolic agents may be warranted.

Fluid-fluid levels in cavernous hemangioma of soft tissue

Five cases of cavernous hemangioma with fluid-fluid levels on magnetic resonance imaging and/or computed tomography are reported. The signal characteristics were those of blood and histological analysis of the fluid-fluid levels showed that they were blood-filled cavities in the tumor. Although this finding itself is not specific, it may help in confirming the diagnosis of cavernous hemangioma.

Cerebral air embolism treated with hyperbaric oxygen therapy following percutaneous transthoracic computed tomography-guided needle biopsy of the lung

A 71-year-old man presented with cough and sputum for 12 months. Chest radiography showed a homogeneous opacity in the right lower lobe. Computed tomography (CT) showed a nodular opacity, 2 cm in diameter, in the posterior segment of the right lower lobe. Mild emphysematous changes were also seen. With the patient in a prone position, a 19-gauge 7.8-cm introducer was placed in the lesion during a single inspiratory breath-hold. A coaxial 20-gauge automated needle was inserted through the introducer using a biopsy gun. Although the patient did not complain of any symptoms, postbiopsy CT showed air in the left ventricle and ascending aorta. After 5 h of bed rest, we found weakness in his left lower extremity. He was transferred to a hyperbaric oxygen chamber and recovered the next day. Air embolism is a rare, potentially fatal complication of percutaneous lung biopsy. Although the true effect of hyperbaric oxygen therapy is controversial, knowledge regarding the prompt management of such cases may help radiologists who perform this procedure.

Is ultrasound-guided central venous port placement effective to avoid pinch-off syndrome?

Purpose Ultrasound (US)-guided internal jugular vein access has been the standard practice of central venous port (CVP) placement. The subclavian vein (SCV) access has also been preferred, but has potential risk of pinch-off syndrome (POS). The purpose of this study was to examine the effect of US-guided SCV access to avoid POS in patients with CVP. Methods Included in this study were patients who had undergone CVP placement via the SCV. We mainly assessed the computed tomography (CT) findings from two different placement techniques of a CVP via the SCV: (i) venipuncture point described by the ratio between the distance from the venipuncture point to the sternoclavicular joint and the clavicular length; and (ii) presence of direct attachment of the catheter to the clavicle. Secondary outcome was POS rate associated with two different placement techniques of CVP via the SCV. Results A total of 237 patients were included in this study between August 2007 and January 2011. A total of 100 patients (42.2%) underwent CVP placement using the landmark technique while 137 patients (57.8%) underwent CVP placement by US guidance. CT revealed that the US-guided technique tended to be lateral SCV approach compared with the landmark technique (p<0.001). A total of four patients (1.7%) experienced POS, all of them in the landmark group. Conclusion Our results showed that the US-guided technique determines a more lateral SCV approach, with a reduced POS risk than the landmark venipuncture technique.

Phase I/II Study of Transjugular Transhepatic Peritoneovenous Venous Shunt, a New Procedure to Manage Refractory Ascites in Cancer Patients: Japan Interventional Radiology in Oncology Study Group 0201

OBJECTIVE This multicenter phase I/II study evaluated the safety and the efficacy of transjugular transhepatic peritoneovenous shunt (PVS), a new palliative treatment for malignant refractory ascites. SUBJECTS AND METHODS Patients with refractory malignant ascites and patent hepatic veins and vena cava were included in this study. Eligible patients underwent the placement of transjugular transhepatic PVS catheter via the jugular vein into the abdominal cavity through the hepatic vein. In phase I, a step-by-step analysis of the safety was performed. The safety and the efficacy were determined through phases I and II. RESULTS Thirty-three patients were entered in this study, nine in phase I and 24 in phase II. Transjugular transhepatic PVS was technically successful in all patients. No severe adverse events were observed during the placement procedure. After the placement, 22 adverse events (grade 2 or higher) occurred. Frequent adverse events were hypoalbuminemia (24%) and decrease in hemoglobin (18%), which resolved within 1 week without additional treatment. The clinical efficacy rate at 1 week after the procedure was 67%. Occlusion of the catheter due to fibrin sheath was observed in seven patients, and the revision of the system was performed. CONCLUSION Transjugular transhepatic PVS is a safe and feasible procedure for managing refractory ascites in patients with cancer. Sufficient efficacy was observed in our initial experience, but a larger clinical trial is warranted.

Phase II Study of Percutaneous Transesophageal Gastrotubing for Patients with Malignant Gastrointestinal Obstruction; JIVROSG-0205

PURPOSE This multicenter, prospective study was conducted to evaluate the efficacy of percutaneous transesophageal gastrotubing (PTEG) as an esophagostomy procedure for bowel decompression in patients with malignant bowel obstruction. MATERIALS AND METHODS The study subjects were patients with malignant bowel obstruction treated with a nasogastric tube (NGT). After receiving PTEG, efficacy evaluations were conducted, with NGT designated as the control state. The procedure was considered effective only when discomfort in the nasopharynx was improved for at least 2 weeks. Safety was evaluated by using National Cancer Institute Common Toxicity Criteria, version 2.0. PTEG was performed by using a PTEG kit. RESULTS From February 2003 to December 2005, 33 patients were enrolled. The technical success rate was 100%, and the procedure was considered effective in 30 of 33 cases. The three cases in which the procedure was ineffective could not be evaluated as a result of deterioration of general status or early death. The one recorded complication was a tracheoesophageal fistula that caused grade 2 aspiration pneumonia. CONCLUSIONS PTEG is an effective technique to relieve discomfort in the nasopharynx caused by NGT in patients with terminal malignant tumors. PTEG should be considered an efficacious method for bowel decompression in patients who are ineligible for surgical procedures, percutaneous gastrostomy, or percutaneous enterostomy.

Interventional radiology for critical hemorrhage in obstetrics: Japanese Society of Interventional Radiology (JSIR) procedural guidelines

AbstractThere has been an increasing demand for interventional radiology (IR) procedures for the treatment of severe postpartum hemorrhage (PPH) (also called critical hemorrhage in obstetrics). The Japanese Society of Interventional Radiology Guideline Committee developed the practical guidelines for IR procedures for severe PPH using evidence-based methodology. This article aimed to describe the rationale for developing these guidelines and to provide the answers for clinical questions about IR procedures consisting of current available evidence and the consensus among experts.

Central venous port-related infection in patients with malignant tumors: An observational study

Abstract Purpose. We evaluated the characteristics of central venous port (CVP)-related infection with microbiological assessments in patients with malignant tumors. Materials and methods. In a prospective setting, patients with CVP for the treatment of malignant tumors were enrolled in this study. The incidence of CVP-related infection during three months was determined. Microbiological surveillance from skin swab was performed before and after CVP placement. Results. Fifty-nine patients were enrolled in this study, and 60 CVPs were implanted. Thirty-six (61%) patients had head and neck malignancies. Access route was subclavian vein in 43 (71.7%) CVPs and forearm vein in 17 (28.3%). CVP-related infection was observed in three (5.1%) patients: port-pocket infection in one and probable CVP-related infection in two patients, respectively. No definitive CVP-related bloodstream infection was observed. Before the placement of CVP, colonization at the insertion site was observed in ten subclavian CVP patients, while no colonization was observed in the forearm CVP patients. At 1 and 4 weeks, detection rates of colonization were also higher in subclavian CVP patients. No definitive relationship was demonstrated between skin colonization and clinical development of CVP-related infection. Conclusion. The rate of CVP-related infection in this prospective evaluation in patients with malignant tumors was comparable to previous studies. Colonization of the skin was more prominent in the subclavian site than in the forearm site. Although skin colonization was not proven to be a risk factor of infection, these results may draw attention to the adequate maintenance of CVP. (Trial registration: UMIN000003664).