Salvage cryotherapy after failed radiofrequency ablation for Barrett's esophagus-related dysplasia is safe and effective.

BACKGROUND: Radiofrequency ablation (RFA) is an effective treatment for Barrett's esophagus (BE) dysplasia. For patients with dysplasia refractory to RFA, data are limited regarding efficacy of endoscopic therapy. OBJECTIVE: To assess the efficacy and safety of cryotherapy in patients with BE dysplasia who failed RFA. DESIGN: Single-center, retrospective, cohort study. SETTING: Tertiary-care center between 2006 and 2013. PATIENTS: Patients with BE and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal carcinoma (IMC) were referred for RFA every 2 to 3 months. Response was determined by complete eradication of dysplasia (CE-D). INTERVENTIONS: Patients without CE-D or those with recurrent dysplasia after initial eradication were offered cryotherapy. MAIN OUTCOME MEASUREMENTS: Eradication of dysplasia and/or cancer. Secondary outcome, eradication of intestinal metaplasia. RESULTS: A total of 121 patients underwent RFA for BE dysplasia (55% HGD, 26% LGD, 17% IMC, 2% indefinite dysplasia). After a median of 3 RFA sessions, 75% (n = 91) had CE-D. Patients without CE-D were more likely to have a longer BE length (7 cm vs 4 cm; P = .004) and a hiatal hernia (83% vs 55%; P = .005). Sixteen patients (14 with failed CE-D and 2 with recurrent dysplasia) were offered cryotherapy and had endoscopic follow-up. Seven (57%) had HGD before cryotherapy (6 with LGD, 2 with IMC, and 1 with indefinite dysplasia). After cryotherapy, 12 (75%) had CE-D, and 5 (31%) had eradication of intestinal metaplasia. Of patients with IMC, 100% had CE-D. Three patients developed strictures that responded to dilation. LIMITATIONS: Single center, retrospective nature of study. CONCLUSION: For patients with refractory dysplasia or recurrent dysplasia after RFA, salvage cryotherapy is a safe and effective endoscopic therapy.

The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial.

BACKGROUND: Oral, live-attenuated rotavirus vaccines suffer from impaired immunogenicity and efficacy in low-income countries. Increasing the inoculum of vaccine might improve vaccine response, but this approach has been inadequately explored in low-income countries. METHODS: We performed a double-blind, parallel group, randomized controlled trial from June 2017 through June 2018 in the urban Mirpur slum of Dhaka, Bangladesh to compare vaccine take (primary outcome) among healthy infants randomized to receive either the standard dose or double the standard dose of oral Rotarix (GlaxoSmithKline) vaccine at 6 and 10 weeks of life. Infants with congenital malformations, birth or enrollment weight <2000 gm, known immunocompromising condition, enrollment in another vaccine trial, or other household member enrolled in the study were excluded. Infants were randomized using random permuted blocks. Vaccine take was defined as detection of post-vaccination fecal vaccine shedding by real-time reverse transcription polymerase chain reaction with sequence confirmation or plasma rotavirus-specific immunoglobulin A (RV-IgA) seroconversion 4 weeks following the second dose. RESULTS: 220 infants were enrolled and randomized (110 per group). 97 standard-dose and 92 high-dose infants completed the study per-protocol. For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24). However, in post-hoc analysis, children with confirmed vaccine replication had significantly increased RV-IgA responses, independent of the intervention. No significant adverse events related to study participation were detected. CONCLUSIONS: Administration of double the standard dose of an oral, live-attenuated rotavirus vaccine (Rotarix) did not improve vaccine take among infants in urban Dhaka, Bangladesh. However, improved immunogenicity in children with vaccine replication irrespective of initial inoculum provides further evidence for the need to promote in-host replication and improved gut health to improve oral vaccine response in low-income settings. ClinicalTrials.gov: NCT02992197.