RESUMEN
AIM: To evaluate the efficacy and safety of undiluted N-butyl-2 cyanoacrylate plus methacryloxysulfolane (NBCM) as a prophylactic treatment for gastric varices (GV) bleeding. METHODS: This prospective study was conducted at a single tertiary-care teaching hospital between October 2009 and March 2013. Patients with portal hypertension (PH) and GV, with no active gastrointestinal bleeding, were enrolled in primary prophylactic treatment with NBCM injection without lipiodol dilution. Initial diagnosis of GV was based on endoscopy and confirmed with endosonography (EUS); the same procedure was used after treatment to confirm eradication of GV. After puncturing the GV with a regular injection needle, 1 mL of undiluted NBCM was injected intranasally into GV. The injection was repeated as necessary to achieve eradication or until a maximum total volume of 3 mL of NBCM had been injected. Patients were followed clinically and evaluated with endoscopy at 3, 6 and 12 mo. Later follow-ups were performed yearly. The main outcome measures were efficacy (GV eradication), safety (adverse events related to cyanoacrylate injection), recurrence, bleeding from GV and mortality related to GV treatment. RESULTS: A total of 20 patients (15 male) with PH and GV were enrolled in the study and treated with undiluted NBCM injection. Only 2 (10%) patients had no esophageal varices (EV); 18 (90%) patients were treated with endoscopic band ligation to eradicate EV before inclusion in the study. The patients were followed clinically and endoscopically for a median of 31 mo (range: 6-40 mo). Eradication of GV was observed in all patients (13 patients were treated with 1 session and 7 patients with 2 sessions), with a maximum injected volume of 2 mL NBCM. One patient had GV recurrence, confirmed by EUS, at 6-mo follow-up, and another had late recurrence with GV bleeding after 35 mo of follow-up; overall, GV recurrence was observed in 2 patients (10%), after 6 and 35 mo of follow-up, and GV bleeding rate was 5% (1 patient). Mild epigastric pain was reported by 3 patients (15%). No mortality or major complications, including embolism, or damage to equipment were observed. CONCLUSION: Endoscopic injection with NBCM, without lipiodol, may be a safe and effective treatment for primary prophylaxis of gastric variceal bleeding.
RESUMEN
BACKGROUND: Patients with liver cirrhosis frequently undergo diagnostic or therapeutic upper GI endoscopy (UGIE), and the liver disease might impair the metabolism of drugs usually administered for sedation. OBJECTIVE AND SETTING: To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE. DESIGN: A prospective, randomized, controlled trial was conducted between February 2008 and February 2009. MAIN OUTCOMES MEASUREMENTS: Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured. RESULTS: Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 µg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 µg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100% vs 88.2%; P < .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P < .001). Complication rates were similar in both groups (14% vs 7.3%; P = .172). LIMITATIONS: Single-blind study; sample size. CONCLUSION: Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.