An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction.

Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group.1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage.2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO).

Aviation and Procedural Medicine.

Aviation and medicine are two complex fields involving many interdependent steps where problems can occur. When they inevitably do the outcome can be catastrophic, leading to injury or even loss of life. While both professions have made great strides to reduce error and improve safety, we would suggest medicine can still learn much from the approach aviation has developed. We will show how pilots spend a significant amount of time on planning and early recognition of impending challenges, utilize the concept of crew resource management routinely, and stay much focused during each specific mission. More importantly, they are very open and committed to discussing every event or near event to improve the system, and are supported in this by their superiors without fear of punishment or retribution. By adopting many of these principles, medicine can develop a true culture of safety such as aviation has done, leading to a remarkable improvement in their safety record.

Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial.

BACKGROUND: The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic biliary drainage (PTBD) to endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction (MHO). METHODS: The INTERCPT trial is a multi-center, comparative effectiveness, randomized, superiority trial of PTBD vs. ERC for decompression of suspected MHO. One hundred and eighty-four eligible patients across medical centers in the United States, who provide informed consent, will be randomly assigned in 1:1 fashion via a web-based electronic randomization system to either ERC or PTBD as the initial drainage and, if indicated, diagnostic procedure. All subsequent clinical interventions, including crossover to the alternative procedure, will be dictated by treating physicians per usual clinical care. Enrolled subjects will be assessed for successful biliary drainage (primary outcome measure), adequate tissue diagnosis, adverse events, the need for additional procedures, hospitalizations, and oncological outcomes over a 6-month follow-up period. Subjects, treating clinicians and outcome assessors will not be blinded. DISCUSSION: The INTERCPT trial is designed to determine whether PTBD or ERC is the better initial approach when managing a patient with suspected MHO, a common clinical dilemma that has never been investigated in a randomized trial. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017.

Multicenter Trial of the VenaTech Convertible Vena Cava Filter.

PURPOSE: To demonstrate rates of successful filter conversion and 6-month major device-related adverse events in subjects with converted caval filters. MATERIALS AND METHODS: An investigational device exemption multicenter, prospective, single-arm study was performed at 11 sites enrolling 149 patients. The VenaTech Convertible Vena Cava Filter (B. Braun Interventional Systems, Inc, Bethlehem, Pennsylvania) was implanted in 149 patients with venous thromboembolism and contraindication to or failure of anticoagulation (n = 119), with high-risk trauma (n = 14), and for surgical prophylaxis (n = 16). When the patient was no longer at risk for pulmonary embolism as determined by clinical assessment, an attempt at filter conversion was made. Follow-up of converted patients (n = 93) was conducted at 30 days, 3 months, and 6 months after conversion. Patients who did not undergo a conversion attempt (n = 53) had follow-up at 6 months after implant. RESULTS: All implants were successful. One 7-day migration to the right atrium required surgical removal. Technical success rate for filter conversion was 92.7% (89/96). Mean time from placement to conversion was 130.7 days (range, 15-391 d). No major conversion-related events were reported. The mean conversion procedure time was 30.7 minutes (range, 7-135 min). There were 89 converted and 32 unconverted patients who completed 6-month follow-up with no delayed complications. CONCLUSIONS: The VenaTech Convertible filter has a high conversion rate and low 6-month device-related adverse event rate. Further studies are necessary to determine long-term safety and efficacy in both converted and unconverted patients.

Case report: gastrointestinal hemorrhage caused by a pancreas transplant arteriovenous fistula with large psuedoanuerysm 9 years after transplantation.

Reported cases of arteriovenous fistulae in transplant recipients are uncommon. We present a case of an arteriovenous fistula associated with a large pseudoaneurysm in the root of the small bowel mesentery of a pancreas transplant. Uniquely, in our case, the arteriovenous fistula presented with an episode of gastrointestinal (GI) hemorrhage 9 years postoperatively. Radiographic imaging including coronal computed tomography angiogram and conventional angiogram demonstrated an arteriovenous fistula in the patient's pancreas transplant between the distal superior mesenteric artery (SMA) and superior mesenteric vein (SMV) with 6 cm aneurysmal dilatation. The tremendous flow in the fistula in the root of the graft small intestine mesentery led to graft duodenal mucosal congestion and lower GI hemorrhage. After successful embolization of the SMA-SMV fistula and pseudoaneurysm using interventional radiographic techniques, the arteriovenous fistula remained thrombosed. The patient had no further episodes of GI bleeding and her endoscopic evaluation was otherwise negative. The presence of arteriovenous fistulae and pseudoaneurysms in pancreas transplant recipients is uncommon, but has been previously documented. This case is further distinguished from previous reports by the notable 9-year interval between transplantation and the onset of hemorrhage. Historically, symptomatic vascular malformations have been associated with significant patient morbidity and mortality. Successful patient management involves timely and accurate diagnosis and intervention.

The effect of manufacturing variables on radiation doses from porcelain tiles.

Previous studies have focused on the radiological properties of glazed ceramic tiles. This study was conducted to describe the radiological properties of porcelain tiles and how they were affected by variations in the manufacturing parameters. The data showed that the majority of the uranium in the tiles was attributable to the addition of zircon while less than half of the thorium in the tile was attributable to the added zircon, and the remainder came from other minerals in the formulation. The effects of firing temperatures and compressive strengths of the tiles are presented and show that higher firing temperatures increase radon emanation, while higher compressive strengths reduce radon emanation. The study also described how the addition of zircon to the tile formulation affected the radiological exposures that could be received by a member of the public from the use of such porcelain tiles. A dose assessment was conducted based on 23 different types of tile formulation. Screening procedures for building materials have been described in European Commission documents, and these limit the addition of zircon in a porcelain tile to approximately 9% by mass. The dose assessment reported in this study showed that 20% zircon could be added to a porcelain tile without exceeding the prescribed dose limits.

Palliative hepatic intraarterial chemotherapy (HIC) using a novel combination of gemcitabine and mitomycin C: results in hepatic metastases.

To evaluate repeated hepatic intraarterial chemotherapy (HIC) as a palliative treatment option for unresectable cholangiocarcinoma and liver metastases of various origins that were progressive under systemic chemotherapy. Between 2002 and 2006, 55 patients were treated in 4-week intervals (mean five sessions). Combined gemcitabine/mitomycin was administered intraarterially within 1 h. Tumor response was evaluated after the third session according to RECIST. Treated tumor entities were colorectal carcinoma (CRC) (n = 12), breast cancer (BC) (n = 12), cholangiocarcinoma (CCC) (n = 10), pancreatic (n = 4), ovarian (n = 3), gastric, cervical, papillary (each n = 2), prostate, esophageal carcinoma, leiomyosarcoma (each n = 1), cancer of unknown primacy (CUP) (n = 5). All patients tolerated the treatment well without any major side effects or complications. In total, there were 1 complete response (CR), 19 partial responses (PR), 19 stable (SD) and 16 progressive diseases (PD). We observed 5 PR, 3 SD and 4 PD in CRC; 1 CR, 4 PR, 6 SD in BC; and 2 PR, 2 SD and 6 PD in CCC. Median survival after first HIC was 9.7 months for CRC, 11.4 months for BC and 6.0 months for CCC. HIC with gemcitabine/mitomycin is a safe, minimally invasive, palliative treatment for hepatic metastases that are progressive under systemic chemotherapy. The treatment yields respectable tumor control rates in CRC and BC patients.

Prostate cancer: MR imaging-guided galvanotherapy--technical development and first clinical results.

PURPOSE: To prospectively evaluate the safety and effectiveness of magnetic resonance (MR) imaging-guided galvanotherapy in prostate cancer. MATERIALS AND METHODS: This prospective study was approved and authorized by the institutional review board, and patients gave informed consent. Forty-four men (mean age, 63.1 years) with histologically proved prostate cancer were treated with galvanotherapy. After transgluteal puncture of the prostate with local anesthesia, two MR imaging-compatible electrodes were positioned under MR imaging guidance in the periphery of the right and left lobes of the prostate so that they had direct tumor contact. The patients were treated three times in 1-week intervals, and direct current was applied to the localized cancer in the prostate gland with a total charge of 350 coulombs. Follow-up with laboratory testing (prostate-specific antigen [PSA] levels) and endorectal MR imaging with tumor volume measurement was performed 3, 6, and 12 months after the procedure. The Friedman test was used to compare tumor volumes and PSA levels across the four time points. RESULTS: All patients tolerated MR imaging-guided galvanotherapy well without any major side effects or complications. Six patients had some reversible difficulty with urination, and five reported temporary unilateral leg paresthesia. Tumor volume as determined with MR imaging decreased from a pretherapeutic median of 1.90 to 1.12 cm(3), which corresponded to a significant (P < .01) reduction of 41%. One patient (2%) had complete remission and 18 (41%) had partial remission at follow-up 12 months after therapy. Twenty-three patients (52%) were classified as having stable disease. Two patients (5%) had progressive disease. Median PSA levels decreased in the 12-month control period from 7.05 to 2.4 ng/mL (66%, P < .01). CONCLUSION: MR imaging-guided galvanotherapy is a safe procedure and can result in local control of prostatic carcinoma, with a concomitant reduction in the PSA level. SUPPLEMENTAL MATERIAL: http://radiology.rsnajnls.org/cgi/content/full/245/2/895/DC1.

Pregnancy plasma glucose levels exceeding the American Diabetes Association thresholds, but below the National Diabetes Data Group thresholds for gestational diabetes mellitus, are related to the risk of neonatal macrosomia, hypoglycaemia and hyperbilirubinaemia.

AIMS/HYPOTHESIS: Gestational diabetes mellitus (GDM) is a risk factor for perinatal complications. In several countries, the criteria for the diagnosis of GDM have been in flux, the American Diabetes Association (ADA) thresholds recommended in 2000 being lower than those of the National Diabetes Data Group (NDDG) that have been in use since 1979. We sought to determine the extent to which infants of women meeting only the ADA criteria for GDM are at increased risk of neonatal complications. MATERIALS AND METHODS: In a multiethnic cohort of 45,245 women who did not meet the NDDG criteria and were not treated for GDM, we conducted nested case-control studies of three complications of GDM that occurred in their infants: macrosomia (birthweight >4,500 g, n = 494); hypoglycaemia (plasma glucose <2.2 mmo/l, n = 488); and hyperbilirubinaemia (serum bilirubin > or =342 micromol/l (20 mg/dl), n = 578). We compared prenatal glucose levels of the mothers of these infants and mothers of 884 control infants. RESULTS: Women with GDM by ADA criteria only (two or more glucose values exceeding the threshold) had an increased risk of having an infant with macrosomia (odds ratio OR = 3.40, 95% CI = 1.55-7.43), hypoglycaemia (OR = 2.61, 95% CI = 0.99-6.92) or hyperbilirubinaemia (OR = 2.22, 95% CI = 0.98-5.04). Glucose levels 1 h after the 100-g glucose challenge that exceeded the ADA threshold were particularly strongly associated with each complication. CONCLUSIONS/INTERPRETATION: These results lend support to the ADA recommendations and highlight the importance of the 1-h glucose measurement in a diagnostic test for GDM.

Comparative results of Doppler sonography after TIPS using covered and bare stents.

OBJECTIVE: Our purpose was to evaluate the role of sonography in the early follow-up of patients with a covered transjugular intrahepatic portosystemic shunt (TIPS). CONCLUSION: Routine baseline Doppler sonography should occur 7-14 days after shunt placement unless malfunction or procedural complications are suspected.

Stent migration complicating treatment of inferior vena cava stenosis after orthotopic liver transplantation.

A case of inferior vena cava (IVC) stenosis after orthotopic liver transplantation was treated with balloon angioplasty and Wallstent placement. There was stent migration into the right atrium (RA), and percutaneous removal of the stent was attempted without success. Open cardiac surgery was required for stent removal and repair of aortic/RA fistula. Months later, recurrent IVC stenosis was successfully treated with placement of large Z stents after additional failed surgical repair. At 2 years follow-up, the patient is asymptomatic and Doppler ultrasonography demonstrated the stent to be patent and well-positioned.

Anatomic relationship of the internal jugular vein and the common carotid artery applied to percutaneous transjugular procedures.

PURPOSE: To demonstrate the anatomic relationship of the internal jugular vein (IJV) with the common carotid artery (CCA) in order to avoid inadvertent puncture of the CCA during percutaneous central venous access or transjugular interventional procedures. METHODS: One hundred and eighty-eight consecutive patients requiring either central venous access or interventional procedures via the IJV were included in the analysis. The position of the IJV in relation to the CCA was demonstrated by portable ultrasonography. The IJV location was recorded in a clock-dial system using the carotid as the center of the dial and the angles were measured. Outcomes of the procedure were also recorded. RESULTS: The IJV was lateral to the CCA in 187 of 188 patients and medial to the CCA in one patient. The left IJV was at the 12 o'clock position in 12 patients (6%), the 11 o'clock position in 17 patients (9%), the 10 o'clock position in 142 patients (75%) and at the 9 o'clock position in 17 patients (9%). The right IJV was at the 12 o'clock position in 8 patients (4%), the 1 o'clock position in 31 patients (16%), the 2 o'clock position in 134 patients (71%) and the 3 o'clock position in 17 patients (9%). In one patient the left IJV was located approximately 60 degrees medial to the left CCA; this was recorded as 2 o'clock on the left since it is opposite to the 10 o'clock position. CONCLUSION: Knowledge of the IJV anatomy and relationship to the CCA is important information for the operator performing an IJV puncture, to potentially reduce the chance of laceration of the CCA and avoid placement of a large catheter within a critical artery, even when ultrasound guidance is used.

Isolated right segmental hepatic duct injury following laparoscopic cholecystectomy.

PURPOSE: Laparoscopic cholecystectomy (LC) is the treatment of choice for gallstones. There is an increased incidence of bile duct injuries in LC compared with the open technique. Isolated right segmental hepatic duct injury (IRSHDI) represents a challenge not only for management but also for diagnosis. We present our experience in the management of IRSHDI, with long-term follow-up after treatment by a multidisciplinary approach. METHODS: Twelve consecutive patients (9 women, mean age 48 years) were identified as having IRSHDI. Patients' demographics, clinical presentation, management and outcome were collected for analysis. The mean follow-up was 44 months (range 2-90 months). RESULTS: Three patients had the LC immediately converted to open surgery without repair of the biliary injury before referral. Treatments before referral included endoscopic retrograde cholangiopancreatography (ERCP), percutaneous drainage and surgery, isolated or in combination. The median interval from LC to referral was 32 days. Eleven patients presented with biliary leak and biloma, one with obstruction of an isolated right hepatic segment. Post-referral management of the biliary lesion used a combination of ERCP stenting, percutaneous drainage and stent placement and surgery. In 6 of 12 patients ERCP was the first procedure, and in only one case was IRSHDI identified. In 6 patients, percutaneous transhepatic cholangiography (PTC) was performed first and an isolated right hepatic segment was demonstrated in all. The final treatment modality was endoscopic management and/or percutaneous drainage and stenting in 6 patients, and surgery in 6. The mean follow-up was 44 months. No mortality or significant morbidity was observed. CONCLUSION: Successful management of IRSHDI after LC requires adequate identification of the lesion, and multidisciplinary treatment is necessary. Half of the patients can be treated successfully by nonsurgical procedures.

Midlife cardiovascular risk factors and risk of dementia in late life.

OBJECTIVE: To evaluate if midlife cardiovascular risk factors are associated with risk of late-life dementia in a large, diverse cohort. METHOD: The authors conducted a retrospective cohort study of 8,845 participants of a health maintenance organization who underwent health evaluations from 1964 to 1973 when they were between the ages of 40 and 44. Midlife cardiovascular risk factors included total cholesterol, diabetes, hypertension, and smoking. Diagnoses of dementia were ascertained by medical records from January 1994 to April 2003. RESULTS: The authors identified 721 participants (8.2%) with dementia. Smoking, hypertension, high cholesterol, and diabetes at midlife were each associated with a 20 to 40% increase in risk of dementia (fully adjusted Cox proportional hazards model: HR 1.24, 95% CI 1.04 to 1.48 for hypertension, HR 1.26, 95% CI 1.08 to 1.47 for smoking, HR 1.42, 95% CI 1.22 to 1.66 for high cholesterol, and HR 1.46, 95% CI 1.19 to 1.79 for diabetes). A composite cardiovascular risk score was created using all four risk factors and was associated with dementia in a dose-dependent fashion. Compared with participants having no risk factors, the risk for dementia increased from 1.27 for having one risk factor to 2.37 for having all four risk factors (fully adjusted model: HR 2.37, 95% CI 1.10 to 5.10). CONCLUSION: The presence of multiple cardiovascular risk factors at midlife substantially increases risk of late-life dementia in a dose dependent manner.