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A multicentre controlled study of the InLine radiofrequency ablation device for liver transection.

ABSTRACT: BACKGROUND: Surgical resection is the most effective therapy for liver cancer. Intraoperative blood loss during liver resection remains a major concern due to association with higher postoperative complications. The InLine radiofrequency ablation device (ILRFA) has achieved promising results in liver surgery with minimal blood loss and no increase of postoperative complications. In this multicentre controlled study, 108 patients undergoing liver resection were investigated. PATIENTS AND METHODS: A total of 108 patients underwent liver resections in 4 medical centres; the prospective sequential cohort study consisted of 54 ILRFA and 54 ultrasonic surgical aspirator transections as the control group. RESULTS: The type of liver resection performed was very similar in both groups. The median number of RFA deployments was 3 (range 1-12) with a median coagulation time of 9 (range 3-36) min. Median blood loss was 165+/-20 ml (range 5-675) in the ILRFA and 654+/-83 ml (range 80-3600) in the control group (p<0.001). The median transection time was 27 (2-219) min in the ILRFA group and 35 (5-62) min in controls. CONCLUSIONS: Our study indicates that ILRFA device for liver transection is effective in reducing blood loss and is safe. Precoagulation before parenchymal transection appears to be a valid concept in liver surgery. The avoidance of vascular inflow occlusion during parenchymal transection could also be of value.

SUBMITTER: Yao P

PROVIDER: S-EPMC2215394 | biostudies-other | 2007

REPOSITORIES: biostudies-other

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Project description:Abstract Objective Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. Methods A prospective, single‐arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device‐related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Results Thirty‐six participants were enrolled and completed follow‐up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p < .0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p < .001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3 months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < .0001). At 3 months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. Conclusions The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post‐procedure. Trial Registration The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence 4. The NEUROMARK System is a novel RF ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvements in symptoms and quality of life assessments at 3 months post‐procedure.

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A multicentre controlled study of the InLine radiofrequency ablation device for liver transection.

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