Comparative EUS Guided Techniques in Treatment of Gastric Varice: a Prospective, Ranzomized Study

Coils that are currently used for intravascular embolization treatments can be delivered under EUS guidance offering a new treatment approach. Romero-Castro et al. previously reported a case series by using up to 20 coils to eradicate gastric fundic varices (GFV) in 4 patients, with a 75% success rate. More recently this author compared in a multicenter study the treatment of GFV using EUS guide injection of N-butyl cyanocryloate with Lipiodol vs. EUS guide injection of coils alone. Both techniques had excellent results with GFV obliteration rate of 94.7% and 90.9% respectively. However 47.4% of the patients in the CYA group required more than one session and 36.4% in the coil group either required additional coil or CYA placement. There was a significant difference in the overall adverse event rate between CYA group (57.9%) and coil group (9.1%), due to glue pulmonary embolism.

Coils in conjunction with CYA injection may reduce or eliminate the risk of glue embolization. Coils with attached synthetic fibers ("wool coils") may function as a scaffold to retain CYA within the varix and may decrease the amount of glue injection needed to achieve obliteration. Binmoeller et al. described them 6 years experience in 152 patients with GFV treated with 2-octyl cyanocrylate plus coils. Patients had active hemorrhage (5%), recent bleeding (69%) or were treated for primary prophylaxis (26%). Treatment was technically successful in 151 patients (>99%), with mean number of coils of 1.4 and mean volume of CYA of 2 ml. Follow-up was possible in 125/151 patients (100 using EUS examinations and 25 with clinical and/or EGD follow-up). Complete obliteration was confirmed with EUS-Doppler image in 93/100 (93%). Post-treatment bleeding occurred in 20 of 125 patients (16%) and only 10 (50%) where GFV related bleeding. Mild post procedure abdominal pain occurred in 4 of 125 patients (3%), and clinical signs of pulmonary embolization were seen in 1 patient (1%). Another 4 of 125 patients (3%) presented with minor delayed upper GI bleeding from coil/glue extrusion.

The aim of this study is to describe and compared efficacy and safety two different EUS guided techniques for GFV treatment (Coils + CYA vs. Coils alone). Efficacy will be measure by technical success defined as successful technique performance and functional success defined as complete obliteration of the varix and absence of Doppler flow on EUS. Safety will be determinated by measure of adverse events related to the procedure or gastric varices within and after 30 days of the procedure.

METHODS Setting: Instituto Ecuatoriano de Enfermedades Digestivas (IECED), OmniHospital Academic Tertiary Center. Patients will be included from March 2016 to June 2017. The study protocol and consent form has been approved by the Institutional Review Board and will be conducted according to the declaration of Helsinki. Patients will sign an informed consent.

All procedures will be performed in a hospital-based interventional endoscopy suite, where fluoroscopy is available, by one endoscopist (C.R.M). Procedures will be performed under general anesthesia and under antibiotics prophylactic. After the procedure, patients will be observed for 2 hours in the recovery room before being discharged. Follow up will be performed by standard endoscopy and EUS at 3 and 6 months post procedure. Hemostasis, early post treatment bleeding and late post treatment bleeding will be considered according Baveno VI concensus. Complete obliteration of the varix will be defined as absence of Doppler flow on EUS.