Vinay Sehgal’s research while affiliated with Cleveland Clinic and other places

Introduction The Cryoballoon Focal Ablation System (CbFAS) (Pentax Medical Inc) is an innovative device designed for the endoscopic ablation of Barrett's-related neoplasia. This system has been shown to provide advantages such as reduced stricture rates and improved patient tolerance compared to the conventional standard of care, radiofrequency ablation (RFA). We report early outcomes from a prospective UK first multi-centre registry of consecutive patients who underwent Cryoablation for the endoscopic eradication (EET) of Barrett’s-related neoplasia. Methods Patients were prospectively enrolled from two tertiary referral centres for Barrett’s Oesophagus (BE). Inclusion criteria included patients with a BE segment no longer than 5cm with histologically-proven dysplasia on biopsy or endoscopic resection specimens suitable for EET of BE after MDT review. Cryoablation sessions were conducted at 3-month intervals until endoscopic eradication was complete. The standardised protocol involved administering 8 seconds per ablation for all enrolled patients with the CbFAS. Our primary outcome was complete eradication of BE. Secondary outcomes included the number of ablations performed, adverse events, device malfunction, stricture rate, patient tolerance, and endoscopist satisfaction which was evaluated using a 10-point Likert scale (1=poor, 10=excellent). Results Between January 2020 and December 2023, a total of 16 patients (35 treatment sessions) were treated. The median BE length was C0M2. Complete eradication of BE was achieved in 89% (8/9) of patients who had completed treatment. No instances of device malfunction or intraoperative adverse events were recorded. A stricture rate of 12.5% (2/16) was observed, both of which were successfully managed through endoscopic dilatation. All patients were recorded as tolerating the procedure well with sedation. The median endoscopist satisfaction score was 9 (+/- 2.4) with only one recorded instance of difficulty attributed to balloon positioning. Conclusions These preliminary results from the UK cryoablation registry suggest that cryoablation with the CbFAS is a safe and effective therapy for BE-related dysplasia. The stricture rate appears to be comparable to that observed with RFA and similar studies. With the planned enrolment of further centres and suitable patients, this registry will further enhance our understanding of the long-term efficacy and safety profile of cryoablation using the CbFAS.

Background Benign oesophageal strictures are commonly encountered in endoscopy and are often effectively managed with endoscopic dilatation. However, up to 40% of patients may develop refractory benign oesophageal strictures (RBES), necessitating frequent endoscopic interventions that are often challenging, pose a greater risk of complications, and negatively impact quality of life. Oesophageal self-dilatation (SD) offers an alternative treatment that potentially reduces the need for repeat hospital visits while allowing patients greater autonomy in managing their condition. We describe the efficacy and safety of oesophageal SD at a tertiary referral centre. Methods We retrospectively reviewed the electronic records of patients with RBES (n=43) who were referred for SD to our centre between 2013 and 2024. The primary outcomes were the endoscopic dilatation-free interval (EDFI; longest period of time patients did not require endoscopic dilatation) and the number of endoscopic procedures performed within 12 months of starting SD. Secondary outcomes included the technical success rate of learning SD, improvement in the Dakkak and Bennett dysphagia score, and complications. Results are reported as median (interquartile range). Results 41/43 patients (median age 57 years) with various RBES aetiologies (32% peptic, 19.5% post-radiation, 12% post-surgical, 11.6% post-endoscopic resection, 24.9% other) and locations (24.4% proximal, 29.3% middle, 34.1% lower, 12.2% multi-segment) successfully learned SD. Median follow-up was 23.2 months. The EDFI increased from 68.5 (41-106) to 161 (121-279) days (P<0.001) while endoscopic interventions decreased from 7 (4.7-10) to 1 (0.75-3) (P<0.001) within 12 months before and after SD. The all-time EDFI was 405 days (130-705) and dysphagia score improved from 2 at baseline to 0 after SD. One patient experienced clinically significant haematemesis and one presumed SD-related oesophageal perforation. Conclusion To our knowledge, we have described the largest European case series of oesophageal SD that has been published to date. Oesophageal SD appears to be an effective, well-tolerated, and safe approach in managing often complex patients with RBES providing a viable alternative to conventional endoscopic interventions. However, the occurrence of adverse events highlights the importance of careful patient selection and ongoing monitoring. Further research is warranted to validate these findings and identify predictive factors for treatment success.

Background Malignant oesophageal strictures can cause airway compromise and fistula formation. Combined oesophageal and airway stenting is a potential treatment yet no guidelines exist. This study aims to describe the outcomes of same-session oesophageal and airway endoscopic stenting for malignant strictures and propose an algorithm for intervention. Methods A retrospective study on patients undergoing same-session gastroenterology (GI) and respiratory endoscopy at University College London Hospital, 2019-2023. All procedures were with anaesthetic-led propofol sedation. Endoscopic decision making was based on pre-procedure multidisciplinary team meeting (MDM) and intra-procedure clinical assessment. Data collected included malignancy type, luminal narrowing, complications, and mortality. Results 26 patients were identified. Mean age was 63 years. Cancer type was oesophageal (81%) or lung (19%). The most common referral indication was dysphagia (42%); airway compromise was often seen on imaging (65%). Stent insertion was oesophageal only (35%), airway only (19%) and dual (27%). Airway stenting was common (80%) if airway stenosis was >50%. No airway stenting occurred if stenosis was <50%. After oesophageal stenting, repeat bronchoscopy showed increased airway stenosis in 4 patients (25%). The only intraoperative complication was one oesophageal perforation. New tracheooesophageal fistula was the most common post-intervention complication (15%). Median time from malignancy diagnosis to death was 7.9 weeks. Conclusion We present the first algorithm (Figure 1) for endoscopic stenting in patients with malignant oesophageal stricture and airway involvement. We suggest upper GI and respiratory MDM to plan same-session endoscopy with decision-making framed by patient-centred goals given their poor prognosis.

Introduction Oesophageal defects are associated with poor morbidity and mortality and often require prolonged hospitalisation and artificial nutrition. Existing endoscopic treatment modalities exhibit limitations. Covered stents are associated with a migration rate of up to 50% and closure with endoscopic clips is limited to simple defects. Vacuum therapy is a well understood and established surgical therapy to promote wound healing. Endoscopic Vacuum Therapy (EVT) utilises these principles in the management of transmural oesophageal defects. The VACstent GITM (MicroTech) is a novel device which synergistically incorporates the advantages of a fully covered oesophageal stent while concurrently employing EVT. This approach seals the defect while mitigating against stent migration through the vacuum effect. Luminal patency is also maintained which helps to preserve nutritional independence. Accelerated healing and enhanced nutrition are thought to help reduce morbidity and enhance patient quality of life. Methods This single-centre prospective case series describes outcomes for patients with transmural oesophageal defects treated with the VACstent GITM device. All procedures were performed with propofol sedation and fluoroscopic guidance. The VACstent GITM was exchanged every 5-7 days until endoscopic closure. A contrast study was used to confirm closure after which oral nutrition was restarted. The primary outcome was clinical success, defined as the endoscopic and radiological evidence of defect closure. Secondary outcomes included number of stent exchanges, technical success, and the adverse event (AE) rate. Results The VACstent GITM device was used for seven patients between October 2023 and February 2024. Four patients had anastomotic leaks with three having iatrogenic perforations. The mean patient age was 60 (± 19.3) years with 57% of the patient cohort being male. The clinical success rate was 86% with a technical success rate of 100% and a median defect closure time of 13 (± 6.6) days. A median number of 1 stent exchanges was required. The median defect size was 8mm (± 6.2). There were no reported AEs. All patients were able to successfully come of artificial nutrition. Conclusion This case series illustrates the safety and efficacy of the VACstent for the treatment of a heterogenous group of oesophageal defects. To our knowledge this represents the largest series in a cohort of patients from the United Kingdom. Larger scale comparative studies incorporating a more diverse patient cohort will further clarify the potential of the VACstent device in reducing the necessity for major surgical interventions in this complex and challenging patient population. It will also help to refine future treatment algorithms for oesophageal defect management.

Introduction Vacuum therapy is a well understood and established surgical therapy to promote wound healing. Endoscopic Vacuum Therapy (EVT) utilises these principles to help in the management of transmural oesophageal defects which often require prolonged hospitalisation and artificial nutrition. The VACstent GITM (MicroTech) device synergistically incorporates the advantages of a temporary fully covered oesophageal stent while concurrently employing EVT. Methods A single-centre prospective case series describing the outcomes for patients with transmural oesophageal defects treated with the VACstent GITM device.All procedures were performed with propofol sedation and fluoroscopic guidance. The VACstent GITM was exchanged every 5–7 days until endoscopic closure. A contrast study was used to confirm closure after which oral nutrition was restarted. The primary outcome was clinical success, defined as the endoscopic and radiological evidence of defect closure. Secondary outcomes included number of stent exchanges, technical success and the adverse event (AE) rate. Results The VACstent GITM device was used for five patients between October 2023 and January 2024. Three patients had post-operative leaks with two having iatrogenic perforations. Mean patient age was 68 years (3/5 male). The clinical success rate was 100% with a technical success rate of 100% and a median defect closure time of 13 (± 6.6) days. A median number of 1 stent exchange was required. The median defect size was 8mm (± 6.2). There were no reported AEs. All patients were able to successfully resume oral nutrition. Conclusion This case series illustrates the safety and efficacy of the VACstent for the treatment of transmural oesophageal defects. This is typically a challenging cohort of patients to treat and to our knowledge represents the largest UK case series. Collecting data on a larger and more diverse patient series will further clarify the potential of the VACstent device and build upon the exciting results we have demonstrated to date.