Safety and feasibility of same-day discharge for per-oral endoscopic myotomy.

AIMS: Per-oral endoscopic myotomy (POEM) is a recognised treatment for achalasia, with the accepted approach involving admission for imaging and dietary progression. However, recent publications suggest same-day discharge (SDD) may be possible, which could be time and cost-saving. We sought to investigate the safety of SDD following POEM. METHODS: Fifty consecutive POEMs at two referral centres in New Zealand were performed between 2020-2023. All patients were planned for early dietary introduction and were eligible for SDD if symptoms were managed. Analgesia was available in recovery and supplied at discharge. Imaging and endoscopy were performed only if there were clinical concerns. Rates of discharge clearance, discharge, complications and re-admission were analysed. RESULTS: All 50 POEMs were technically successful. A total of 41/50 (82%) received clearance for SDD. Additionally, 35/50 (70%) achieved discharge and 6/50 (12%) were observed overnight for social reasons, including lack of transport to the referring domicile. Of the patients not cleared for SDD, 7/9 (78%) were discharged within 24 hours, and the others after 48 and 72 hours. Procedural complications were recorded in three patients (6%), with one requiring endoscopic assessment and clipping. There were two re-admissions (4%), both lt;24-hour hospital stays, and managed medically. CONCLUSIONS: The majority of patients achieved same-day discharge clearance (82%) and 96% required less than 24 hours hospital stay. Complication and re-admission rates were low overall. We have demonstrated that POEM can be an SDD procedure facilitated by early dietary introduction and liberal analgesia, without the need for routine imaging or endoscopy.

Rare finding of a symptomatic epidermoid cyst of the diaphragm - a case report.

Cystic lesions of the diaphragm are rare and accordingly present a diagnostic challenge. Specific radiological features with which to clinch a diagnosis may be elusive. Herein we present the case of a patient who presented with symptoms attributable to a cyst in the left upper abdomen, irritating the diaphragm. Surgery was considered appropriate for diagnostic and symptomatic purposes. Final histology demonstrated an epidermoid cyst. Resolution of symptoms was reported after surgery. Diaphragmatic epidermoid cysts appear to be a rare entity with only three prior cases reported in the literature. Given the rarity of this lesion and the lack of unique features by which they can be characterized, accurately diagnosing epidermoid cysts of the diaphragm is likely to remain difficult without surgery, although they are presumed to have a benign behaviour.

Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses.

Background & Aims: The investigational first-generation core inhibitor vebicorvir (VBR) demonstrated safety and antiviral activity over 24 weeks in two phase IIa studies in patients with chronic HBV infection. In this long-term extension study, patients received open-label VBR with nucleos(t)ide reverse transcriptase inhibitors (NrtIs). Methods: Patients in this study (NCT03780543) previously received VBR + NrtI or placebo + NrtI in parent studies 201 (NCT03576066) or 202 (NCT03577171). After receiving VBR + NrtI for ≥52 weeks, stopping criteria (based on the treatment history and hepatitis B e antigen status in the parent studies) were applied, and patients either discontinued both VBR + NrtI, discontinued VBR only, or continued both VBR + NrtI. The primary efficacy endpoint was the proportion of patients with HBV DNA <20 IU/ml at 24 weeks off treatment. Results: Ninety-two patients entered the extension study and received VBR + NrtI. Long-term VBR + NrtI treatment led to continued suppression of HBV nucleic acids and, to a lesser extent, HBV antigens. Forty-three patients met criteria to discontinue VBR + NrtI, with no patients achieving the primary endpoint; the majority of virologic rebound occurred ≥4 weeks off treatment. Treatment was generally well tolerated, with few discontinuations due to adverse events (AEs). There were no deaths. Most AEs and laboratory abnormalities were related to elevations in alanine aminotransferase and occurred during the off-treatment or NrtI-restart phases. No drug-drug interactions between VBR + NrtI and no cases of treatment-emergent resistance among patients who adhered to treatment were observed. Conclusions: Long-term VBR + NrtI was safe and resulted in continued reductions in HBV nucleic acids following completion of the 24-week parent studies. Following treatment discontinuation, virologic relapse was observed in all patients. This first-generation core inhibitor administered with NrtI for at least 52 weeks was not sufficient for HBV cure. Clinical trial number: NCT03780543. Impact and implications: Approved treatments for chronic hepatitis B virus infection (cHBV) suppress viral replication, but viral rebound is almost always observed after treatment discontinuation, highlighting an unmet need for improved therapies with finite treatment duration producing greater therapeutic responses that can be sustained off treatment. First-generation core inhibitors, such as vebicorvir, have mechanisms of action orthogonal to standard-of-care therapies that deeply suppress HBV viral replication during treatment; however, to date, durable virologic responses have not been observed after treatment discontinuation. The results reported here will help researchers with the design and interpretation of future studies investigating core inhibitors as possible components of finite treatment regimens for patients with cHBV. It is possible that next-generation core inhibitors with enhanced potency may produce deeper and more durable antiviral activity than first-generation agents, including vebicorvir.