Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thromboembolic infrainguinal disease (DUET): design and rationale

Background: The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US) has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease) is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis.Methods/design: Sixty adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A) or US-accelerated thrombolysis (group B). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery.Discussion: The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications. Trial registration: Current Controlled Trials ISRCTN72676102

Evaluation of a Noise Reduction Imaging Technology in Iliac Digital Subtraction Angiography: Noninferior Clinical Image Quality with Lower Patient and Scatter Dose

AbstractPurposeTo determine whether equivalent-quality images can be obtained from digital subtraction angiography (DSA) of the iliac artery after implementation of a novel imaging technology that reduces patient and scatter x-ray dose.Materials and MethodsImaging using two randomly ordered DSA runs was performed in 51 adults scheduled for iliac artery angiography or intervention or both. One DSA run used standard acquisition chain and image processing algorithms (referred to as “ reference DSA”), and the other DSA run used dose-reduction and real-time advanced image noise reduction technology (referred to as “study DSA”). The quality of each pair of runs, consecutively performed without changes in working projection or injection parameters, was independently rated by five radiologists blinded to the imaging technology used. Patient radiation dose was evaluated using air kerma and dose area product, and scatter dose was evaluated using three dosimeters (DoseAware, Philips Healthcare, Best, The Netherlands), located at fixed positions.ResultsComparable image pairs were available in 48 patients. There were 44 patients undergoing treatment involving the common (n = 33) or external (n = 29) iliac arteries. Study DSA images were rated as equal to or better than reference DSA images for 96% of comparisons, with an average overall agreement among raters of 0.93 (95% confidence interval, 0.65–0.96). Mean patient radiation dose (n = 48) and scatter dose rate for the three dosimeters (n = 50) was 83% ± 5 and 69% ± 10 lower, respectively, using the study technology (P < .001).ConclusionsIliac artery DSA performed using a dose-reduction and real-time advanced image noise reduction technology results in image quality that is noninferior to conventional DSA but with significantly lower patient and scatter radiation exposure (P < .001)

Biliopancreatic and biliary leak after pancreatoduodenectomy treated by percutaneous transhepatic biliary drainage

Background: Complementary to percutaneous intra-abdominal drainage, percutaneous transhepatic biliary drainage (PTBD) might ameliorate healing of pancreatic fistula and biliary leakage after pancreatoduodenectomy by diversion of bile from the site of leakage. This study evaluated technical and clinical outcomes of PTBD for this indication. Methods: All patients undergoing PTBD for leakage after pancreatoduodenectomy were retrospectively evaluated in two tertiary pancreatic centers (2014–2019). Technical success was defined as external biliary drainage. Clinical success was defined as discharge with a resolved leak, without additional surgical interventions for anastomotic leakage other than percutaneous intra-abdominal drainage. Results: Following 822 pancreatoduodenectomies, 65 patients (8%) underwent PTBD. Indications were leakage of the pancreaticojejunostomy (n = 25; 38%), hepaticojejunostomy (n = 15; 23%) and of both (n = 25; 38%). PTBD was technically successful in 64 patients (98%) with drain revision in 40 patients (63%). Clinical success occurred in 60 patients (94%). Leakage resolved after median 33 days (IQR 21–60). PTBD related complications occurred in 23 patients (35%), including cholangitis (n = 14; 21%), hemobilia (n = 7; 11%) and PTBD related bleeding requiring re-intervention (n = 4; 6%). In hospital mortality was 3% (n = 2). Conclusion: Although drain revisions and complications are common, PTBD is highly feasible and appears to be effective in the treatment of biliopancreatic leakage after pancreatoduodenectomy