Embolization of the gastroduodenal artery before selective internal radiotherapy: a prospectively randomized trial comparing platinum-fibered microcoils with the Amplatzer Vascular Plug II.

The Amplatzer Vascular Plug II (AVP II) is a novel device for transcatheter vessel occlusion, for which only limited comparative data exist. Embolotherapy of the gastroduodenal artery (GDA) is essential before internal radiotherapy (SIRT) in order to prevent radiation-induced peptic ulcerations due to migration of yttrium-90 microspheres. The purpose of this study was to compare the vascular anatomical limitations, procedure time, effectiveness, and safety of embolization of the GDA with coils versus the AVP II. Fifty patients stratified for SIRT were prospectively randomized for embolization of the GDA with either coils or the AVP II. The angle between the aorta and the celiac trunk, diameter of the GDA, fluoroscopy time and total time for embolization, number of embolization devices, complications, and durability of vessel occlusion at follow-up angiography for SIRT were recorded. A t-test was used for statistical analysis. Embolizations with either coils or the AVP II were technically feasible in all but two patients scheduled for embolization of the GDA with the AVP II. In both cases the plug could not be positioned due to the small celiac trunk outlet angles of 17 degrees and 21 degrees. The mean diameter of the GDA was 3.7 mm (range, 2.2-4.8 mm) for both groups. The procedures differed significantly in fluoroscopy time (7.8 min for coils vs. 2.6 min for the AVP II; P < 0.001) and embolization time (23.1 min for coils vs. 8.8 min for the AVP II; P < 0.001). A mean of 6.0 +/- 3.2 coils were used for GDA embolization, while no more than one AVP II was needed for successful vessel occlusion (P < 0.001). One coil migration occurred during coil embolization, whereas no procedural complication was encountered with the use of the AVP II. Vessel reperfusion was noted in only one patient, in whom coil embolization was performed. In conclusion, embolization of the GDA with the AVP II is safe, easy, rapid, and highly effective; only an extremely sharp-angled celiac trunk outlet represented an anatomical limitation for device deployment.

RCT Entities:   Population Interventions Outcomes