EUS-guided celiac plexus radiofrequency ablation using a novel device.
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ABSTRACT:
SUBMITTER: Houmani ZS
PROVIDER: S-EPMC7482177 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC7570976 | biostudies-literature
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| S-EPMC7730508 | biostudies-literature
Project description:EUS-guided radiofrequency ablation (RFA) and ethanol ablation (EA) for pancreatic neuroendocrine tumors (PNETs) have recently been reported with good outcomes. We performed a systematic review and meta-analysis to evaluate the comparative effectiveness and safety of EUS-RFA and EUS-EA in the treatment of PNETs. A comprehensive search of multiple databases (through October 2020) was performed to identify studies that reported outcomes of EUS-RFA and EUS-EA of PNETs. Outcomes assessed included clinical success, technical success, and adverse events (AEs). A total of 181 (100 EUS-RFA, 81 EUS-EA) patients (60.7 ± 9.2 years) with 204 (113 EUS-RFA, 91 EUS-EA) PNETs (mean size 15.1 ± 4.7 mm) were included from 20 studies. There was no significant difference in the rates of technical success (94.4% [95% confidence interval (CI): 88.5-97.3, I2 = 0] vs. 96.7% [95% CI: 90.8-98.8, I2 = 0]; P = 0.42), clinical success (85.2% (95% CI: 75.9-91.4, I2 = 0) vs. 82.2% [95% CI: 68.2-90.8, I2 = 10.1]; P = 0.65), and AEs (14.1% [95% CI: 7.1-26.3, I2 = 0] vs. 11.5% [95% CI: 4.7-25.4, I2 = 63.5]; P = 0.7) between EUS-RFA and EUS-EA, respectively. The most common AE was pancreatitis with the rate of 7.8% and 7.6% (P = 0.95) for EUS-RFA and EUS-EA, respectively. On meta-regression, the location of PNETs in head/neck of pancreas (P = 0.03) was a positive predictor of clinical success for EUS-RFA. EUS-RFA and EUS-EA have similar effectiveness and safety for PNETs ablation. Head/neck location of PNETs was a positive predictor for clinical success after EUS-RFA.
| S-EPMC9258014 | biostudies-literature
Project description:Pancreatic neuroendocrine neoplasms (PanNENs) are rare tumors, but their incidental diagnosis has significantly increased due to the widespread use of imaging studies. Therefore, most PanNENs are now diagnosed when completely asymptomatic and in early stages. PanNENs are classified according to their grade (Ki-67 index) and can be functional (F-) or nonfunctional (NF-) depending on the presence or absence of a clinical, hormonal hypersecretion syndrome. The mainstay treatment of PanNENs is a surgery that is mostly curative but also associated with significant short- and long-term adverse events. Therefore, less invasive alternative locoregional treatment modalities are warranted. Recently, few case reports and two case series have described EUS-guided radiofrequency ablation (EUS-RFA) for the treatment of patients with both F-PanNENs and NF-PanNENs. If for F-PanNENs EUS-RFA can very easily become the standard of care, for NF-PanNENEs it is still controversial how to select patients for EUS-RFA. A balance between overtreatment (i.e., RFA/surgery in patients who will not progress) and undertreatment (locoregional treatments in patients with undetected metastases) needs to be found based on solid data. The decision should also take into account patients' comorbidity and risk of postoperative death, life expectancy, tumor location, risk of postoperative fistula and postoperative morbidity, and risk of long-term exocrine and/or endocrine insufficiency. To answer the important question on which a patient should be treated with EUS-RFA, properly designed studies to evaluate the efficacy of this treatment in large cohorts of patients with NF-PanNENs and to establish prognostic factors associated with treatment response are urgently needed.
| S-EPMC6714479 | biostudies-literature
Project description:Background and study aims Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for pancreatic neuroendocrine tumors (NETs) and intraductal pancreatic mucinous neoplasia (IPMN) with worrisome features or high-risk stigmata (WF/HRS) has been evaluated in few series with short-term outcomes. This study's primary endpoint was to assess the long-term efficacy of EUS-RFA in patients with NETs or pancreatic cystic neoplasms (PCNs) over at least 3 years. Patients and methods Twelve patients had 14 NETs with a mean 13.4-mm size (10-20) and 17 patients had a cystic tumor (16 IPMN, 1 MCA) with a 29.1-mm mean size (9-60 were included. They were treated with EUS-guided RFA, evaluated prospectively at 1 year, and followed annually for at least 3 years. Results The mean duration of follow-up was 42.9 months (36-53). Four patients died during follow-up (17-42 months) from unrelated diseases. At 1-year follow-up, and 85.7 % complete disappearance was seen in 12 patients with 14 NETs. At the end of follow-up (45.6 months), complete disappearance of tumors was seen in 85.7 % of cases. One case of late liver metastasis occurred in a patient with initial failure of EUS-RFA. At 1-year follow-up, a significant response was seen in 70.5 % of 15 patients with PCNs. At the end of the follow-up, there was a significant response in 66.6 % with no mural nodules. Two cases of distant pancreatic adenocarcinoma unrelated to IPMN occurred. Conclusions EUS-RFA results for pancreatic NETs or PCNs appear to be stable during 42 months of follow-up.
| S-EPMC8383082 | biostudies-literature
Project description:Video 1EUS-guided ethanol ablation of metastatic functional insulinoma.
| S-EPMC8503933 | biostudies-literature
Project description:ObjectivesThis study aimed to evaluate the therapeutic outcomes of transarterial chemoembolization combined with radiofrequency ablation (TACE + RFA) for hepatocellular carcinomas (HCC) measuring ≤3 cm infeasible for ultrasound (US)-guided percutaneous RFA.MethodsTwenty-four patients who underwent fluoroscopy-guided TACE + RFA for single HCC between January 2012 and December 2016 were screened. To evaluate the TACE + RFA outcomes compared with those of US-guided RFA, 371 patients who underwent US-guided RFA during the same period were screened. We compared local tumor progression (LTP) and intrahepatic distant recurrence (IDR) between the two groups before and after propensity score (PS) matching, and performed univariable and multivariable Cox proportional hazard regression analyses for all patients.ResultsPS matching yielded 21 and 42 patients in the TACE + RFA and US-guided RFA groups, respectively. Cumulative LTP rates after PS matching were not significantly different between the two groups at 1 (0.0% vs. 7.4%, p = 0.072), 2 (10.5% vs. 7.4%, p = 0.701), and 5 years (16.9% vs. 10.5%, p = 0.531). IDR rates did not differ significantly between the two groups at 1 (20.6% vs. 10%, p = 0.307), 2 (25.9% vs. 25.9%, p = 0.999), or 5 years (49.9% vs. 53%, p = 0.838). Multivariable analysis showed that treatment type was not a significant factor for LTP or IDR.ConclusionThe outcomes of TACE + RFA for HCC were similar to those of general US-guided RFA. Fluoroscopy-guided TACE + RFA may be an effective treatment when US-guided RFA is not feasible.
| S-EPMC10650828 | biostudies-literature
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.
| S-EPMC7208897 | biostudies-literature
Project description:Background and aimsPortal hypertension is a serious adverse event of liver cirrhosis. Recently, we developed a simple novel technique for EUS-guided portal pressure gradient (PPG) measurement (PPGM). Our animal studies showed excellent correlation between EUS-PPGM and interventional radiology-acquired PPGM. In this video we demonstrate the results of the first human pilot study of EUS-PPGM in patients with liver disease.MethodsEUS-PPGM was performed by experienced endosonographers using a linear echoendoscope, a 25-gauge FNA needle, and a novel compact manometer. The portal vein and hepatic vein (or inferior vena cava) were targeted by use of a transgastric or transduodenal approach. Feasibility was defined as successful PPGM in each patient. Safety was based on adverse events captured in a postprocedural interview.ResultsTwenty-eight patients underwent EUS-PPGM with 100% technical success and no adverse events. PPG ranged from 1.5 to 19 mm Hg and had excellent correlation with clinical parameters of portal hypertension, including the presence of varices (P = .0002), PH gastropathy (P = .007), and thrombocytopenia (P = .036).ConclusionThis novel technique of EUS-PPGM using a 25-gauge needle and compact manometer is feasible and appears safe. Given the availability of EUS and the simplicity of the manometry setup, EUS-guided PPG may represent a promising breakthrough for procuring indispensable information in the management of patients with liver disease.
| S-EPMC6205538 | biostudies-literature
Project description:Background and objectivesPostoperative safety outcomes with laparoscopic intra-abdominal ultrasound-guided radiofrequency ablation, as performed by gynecologic surgeons new to the procedure, were evaluated and compared to the premarket, pivotal study. Post-procedure feedback from surgeons was reported.MethodsThis was a post-market, prospective, single-arm analysis with 4 to 8 weeks follow-up among surgeons (n = 29) with varying levels of laparoscopic surgery experience participating in the ongoing, multinational Treatment Results of Uterine Sparing Technologies randomized clinical trial. Patients were premenopausal adult women (n = 110) desiring uterine-conserving treatment for symptomatic fibroids. During run-in, surgeons received proctored training. Following training, and after performing ≥ 2 procedures, surgeons provided self-assessment and feedback using a standardized form.ResultsSurgeons performed 105 procedures with 100 per-protocol patients. The average number of proctored cases per surgeon was 2.48. No acute (≤ 48 hours) serious adverse events occurred (0/101, 0.0%) compared with 2 acute serious adverse events in the premarket study (2/137, 1.46%). Both studies reported 1 near-term (∼30 days) serious adverse event (< 1% for both). In this study, the near-term complication was fever of unknown origin requiring hospitalization related to uterine entry/manipulation. This was categorized as probably device-related; the patient was treated with antibiotics and discharged. Twenty-six surgeons completed the evaluation form; none reported experiencing problems with the procedure.ConclusionMinimally invasive gynecologic surgeons can learn laparoscopic intraabdominal ultrasound-guided radiofrequency ablation and perform it safely (in terms of acute and near-term serious adverse events) after ≥ 2 proctored cases. There were no significant differences in safety outcomes compared to the premarket, pivotal study.
| S-EPMC7810431 | biostudies-literature