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Endoscopic treatment of symptomatic insulinoma with a new EUS-guided radiofrequency ablation device.

ABSTRACT:

SUBMITTER: Jonica ER

PROVIDER: S-EPMC7570976 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Endoscopic treatment of symptomatic insulinoma with a new EUS-guided radiofrequency ablation device.

Jonica Emily R ER Wagh Mihir S MS

VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy 20200627 10

PMID: 33103004

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Project description:Long term prognosis and 5-year survival for pancreatic adenocarcinoma (PDAC) remains suboptimal. Endoscopic ultrasound (EUS) guided RFA (EUS-RFA) is an emerging technology and limited data exist regarding safety and long-term outcomes. The aim of this study is to report safety-profile, feasibility and outcomes of EUS-RFA for advanced PDAC. Prospective review of patients with diagnosis of locally-advanced or metastatic PDAC undergoing EUS-RFA between October 2016 to March 2018 with long-term follow up (> 30 months). Study patients underwent a total of 1-4 RFA sessions. All patients were enrolled in longitudinal cohort study and received standard of care chemotherapy. 10 patients underwent EUS-RFA. Location of the lesions was in the head(4), neck(2), body(2), and tail(2). 22 RFA sessions were performed with a range of 1-4 sessions per patient. There were no major adverse events (bleeding, perforation, infection, pancreatitis) in immediate (up to 72 h) and short-term follow up (4 weeks). Mild worsening of existing abdominal pain was noted during post-procedure observation in 12/22 (55%) of RFA treatments. Follow-up imaging demonstrated tumor progression in 2 patients, whereas tumor regression was noted in 6 patients (> 50% reduction in size in 3 patients). Median survival for the cohort was 20.5 months (95% CI, 9.93-42.2 months). Currently, 2 patients remain alive at 61 and 81 months follow-up since initial diagnosis. One patient had 3 cm PDAC with encasement of the portal confluence, abutment of the celiac axis, common hepatic and superior mesenteric artery. This patient had significant reduction in tumor size and underwent standard pancreaticoduodenectomy. In our experience, EUS-RFA was safe, well-tolerated and could be concurrently performed with standard chemotherapy. In this select cohort, median survival was improved when compared to published survival based upon SEER database and clinical trials. Future prospective trials are needed to understand the role of EUS-RFA in overall management of PDAC.

Project description:Abstract Primary Aldosteronism (PA) carries significant cardiometabolic risk, over and above those attributable to hypertension alone. The Endocrine Society guidelines recommend adrenalectomy in those with unilateral disease. However surgery is likely to become unsustainable in public healthcare systems as more patients are diagnosed with PA. Already, surgery may not be feasible in some patients due to co-morbidities, others are reluctant to have the whole adrenal gland removed when excess aldosterone can be localised to small APA(s) in 1 gland. The FABULAS Study explores if EUS-RFA is a safe alternative to left-sided adrenalectomy (ClinicalTrials.gov ID NCT03405025). This multicentre phase-1 study comprises 3 groups of 10 patients with proven PA and left APAs. Successive groups have an increasing benefit:risk ratio for surgery. The first 4 ablation procedures are assessed by an independent safety committee before progression into the next, overlapping group. The primary outcomes are safety and feasibility of EUS-RFA. Safety is assessed throughout the study, including measures of intra-procedure adrenomedullary activation. Efficacy is evaluated by biochemistry, home / clinic BPs, and quantitative 11C-metomidate PET-CT at baseline and 6 months post-ablation. RFA is performed using a Starmed catheter, small enough to pass through a 19-gauge needle, through the stomach. Ablation has been performed in 6 patients (median age 63-years). Mean tumour size was 17mm (range 12-36mm). Plasma metanephrine levels remained stable during RFA. 2 adverse events occurred within the first 48hours post-ablation: AF in a patient with known paroxysmal AF, and an episode of pyrexia and raised CRP attributed to tissue infarction. Both events were deemed ‘not unexpected’ by the safety committee. Most patients have benefited clinically post-ablation. This is illustrated by a 65-year-old man with previously uncontrolled hypertension despite 4 antihypertensive medications, including spironolactone. Baseline aldosterone/renin ratio (ARR) was >200 (PA likely if ARR>60). PET CT revealed a 15mm left adrenal nodule with avid metomidate uptake and an SUVmax ratio of 1.92 (SUVmax ratio >1.25 suggestive of unilateral disease). He underwent uneventful EUS-RFA. 6 months post-ablation his ARR has normalised to 26. On repeat PET CT the metomidate avid adenoma is no longer hot, with a drop in both the SUVmax measured over the APA (31 pre-, and 5 post-ablation) and a reduction in the SUVmax ratio to 1.04. Most importantly, his home BP averages 124/83mmHg and he is thrilled to be off all treatment. Retrospective reports exist of successful percutaneous and retroperitoneal RFA of APAs. FABULAS is the first prospective study, using a minimally invasive, endoscopic route. If proven to be safe and effective EUS-RFA will open the doors for more patients to receive definitive treatment, potentially even those with bilateral disease.

Dataset Information

Endoscopic treatment of symptomatic insulinoma with a new EUS-guided radiofrequency ablation device.

Publications

Endoscopic treatment of symptomatic insulinoma with a new EUS-guided radiofrequency ablation device.

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