Bleeding from gastric varices (GV) is associated with high mortality. Injection of cyanoacrylate (CYA) using standard gastroscopes (SG) presents higher hemostasis and lower re-bleeding rates compared to band ligation or sclerotherapy. Nevertheless, CYA-SG is associated with some adverse events. EUS-guided coils alone technique presents less adverse events, but it shows lower obliteration rate compared with EUS-guided CYA alone, with a significantly higher health care cost. To date, there is no data regarding comparison between EUS-guided coils+CYA vs. EUS-guided coils alone. to compare efficacy and safety of coils+CYA vs. coils alone in the EUS-guided management of GOV II and IGV I. Single-center, randomized, controlled trial (March-2016 - June-2017). Study protocol was approved by Institutional Review Board. Written informed consent was obtained. Selection criteria: 18-80 yo, hepatic cirrhosis with endoscopic evidence of GOV II or IGV I (Sarin classification), >50000 platelets/mL, INR≤2, not into Hepatorenal Syndrome. After randomization, two groups were formed. EUS procedure was performed by a 1° endoscopist, blind to patients’ history. EUS follow-up was performed 3 months later by a 2° endoscopist, blind to 1° EUS. Efficacy definition: EUS-Doppler evidenced GV obliteration, immediate GV disappearance, and later reappearance. Safety definition: complications and re-bleeding rate in a 30 days-follow up. Sample size considered 5% α-error, β-error 20%, and success rate for complete obliteration after 1° EUS-guided coils vs. EUS-CYA procedure (82% & 53%) described by Romero-Castro et. al. Differences between groups were established through respective hypothesis testing; p<0.01 was considered to be statistically significant. Endpoints were estimated through relative risk (RR). Analyses were performed using R v3.4.2. 59 patients were successfully included: 30 to EUS-guided coils+CYA, 29 to EUS-guided coils alone group. There were no statistical differences in baseline characteristics between groups (table 1), although a higher number of coils were necessary to manage bleeding in coils alone group (p<0.01). Compared to coils alone, coils+CYA technique exposes >6 times immediate GV disappearance (RR 6.3, 95% CI 2.5 – 15.8; p<0.01), with 10% more cases of complete obliteration, 10% less re-bleeding, preventing 14% GV reappearance and saving 14% re-interventions. There were no difference regarding adverse events in both groups (table 2). Due of a significant capability for disappearing GV, higher obliteration rate, lower re-bleeding, and GV reappearance prophylaxis; compared with EUS-guided coils alone, EUS-guided coils+CYA represent an effective technique in the management of GOV II and IGV I. Meanwhile, EUS-guided coils+CYA results to be as safe as EUS-guided coils alone.Tabled 1Table 1. Baseline characteristics.EUS-guidedCoils + CYA(n = 30)EUS-guidedCoils alone(n = 29)p-valueAge (years), mean ± SD61.77 ± 7.861.59 ± 12.50.947aGender (female), n (%)14 (46.7)10 (34.5)0.492bCirrhosis etiology, n (%)Alcohol7 (23.3)9 (31.0)0.710bNASH23 (76.6)20 (69.0)0.710bCirrhosis severityChild-Pugh Score, median (range min-max)6 (5 - 9)6 (5 - 11)0.362dChild-Pugh Score, n (%)A, n (%)28 (93.3)25 (86.2)0.508bB, n (%)2 (6.6)3 (10.3)C, n (%)01 (3.4)MELD Score, median (range)9 (6 - 13)9 (6 - 30)0.951dIndication1st Prophylaxis, n (%)3 (10.0)4 (13.8)0.707c2nd Prophylaxis, n (%)27 (90.0)25 (86.2)Active bleeding1/27 (3.7)4/25 (16.0)0.183ca. Student’s t-test; b. Chi-squared test; c. Fisher test; d. U-Mann Whitney test. Open table in a new tab Tabled 1Table 2. Varices characteristics, therapeutic approach, immediate and mediate outcomes.EUS-guidedCoils + CYA(n = 30)EUS-guidedCoils alone(n = 29)p-valueVarices initial evaluation and therapeutic approachType, n (%)GOV II19 (63.3)12 (41.4)0.153bIGV I11 (36.6)17 (58.6)Diameter (mm), n (%)21 (10 -32)25 (10 – 38)0.329dNo. of placed coils, median (range)2 (1 – 3)3 (1 – 7)0.009dPlaced coil size, n (%)10 mm15/30 (50.0)19/29 (65.5)0.412c12 mm12/30 (40.0)13/29 (44.8)0.062c14 mm11/30 (36.6)12/29 (41.4)0.153c16 mm12/30 (40.0)13/29 (44.8)0.742cCYA volume (ml), median (range)1.80 (1.20 – 2.40)n/an/aImmediate therapeutic evaluationTechnical success, n (%)30 (100.0)29 (100.0)n/aComplete obliteration, n (%)30 (100.0)26 (89.7)0.112cVarices disappearance, n (%)26 (86.6)4 (13.8)<0.001bAdverse events, n (%)00n/aFollow-up evaluationRe-bleeding, n (%)2/30 (6.6)5/29 (17.2)0.454cVarices Reappearance, n (%)3/26 (11.5)1/4 (25.0)0.173cRe-intervention, n (%)4/30 (13.3)8/29 (27.6)0.300bType of re-intervention, n (%)Ligation0/42/8 (25.0)Coils1/4 (25.0)1/8 (12.5)Coils + CYA3/4 (75.0)5/8 (62.5)Adverse events, n (%)2/30 (6.7)1/29 (3.4)1.000cType of adverse event, n (%)Pain1/2 (50.0)1/1 (100.0)Fever1/2 (50.0)0a. Student’s t-test; b. Chi-squared test; c. Fisher test; d. U-Mann Whitney test. Open table in a new tab
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