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2018-02
2020-02
2021-02
20
NCT03417843
HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
INTERVENTIONAL
Safety and Efficacy of an Ablation Catheter for the Treatment of Pancreatic Premalignant Cyctic Lesions.
This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic premalignant and early malignant cystic lesion. The ablation is performed using EUSRA needle and radiofrequncy waves under ultrasound imaging. The method will be exaimened on patients who are candidates for surgical intervention and to examine the ability of the method to serve as an alternative to surgical intervention.
In recent years, local and non-invasive intervention methods have been attempted to eliminate or at least reduce the growth of pancreatic lesions. Over the past two years there has been considerable but not successful experience in ablation (burning) of lesions by direct alcohol injection and / or other drugs into the cyst through the EUS. To date, treatment has been performed in three groups of patients in a clinical trial and has shown clinical success from 33% to 70%. However, it should be noted that there is a large incidence of treatment failure and also complications such as pancreatitis. An interesting alternative to surgical intervention is the local destruction of the cyst by radio waves ENDOSCOPIC RADIOFREQUENCY (RF). This is a familiar local method that works by releasing heat that causes necrosis and disappearance of the lesion.High efficacy and high safety profile were reported for this method; 90% of the cases showed disappearance of of metaplasia by the follow-up of 5 years and 80% disappearance of dysplasia (both early and advanced) followed by two and a half years. In addition, in recent years EMCISION has developed a catheter called ENDO HBP HABIB. It is a thin RF probe that can be inserted through work channels of all types of endoscopes and cholangioscopes. The depth of the penetration of heat and energy intensity is in accordance with the resistance of the tissue being treated, and the device operates under the computerized control of an ultrasound device with high resolution. This method showed success in short-term follow-up in preliminary research.The technical difficulty of this therapeutic method is related to the limitation of the ability to position itself precisely by inserting the catheter through the EUS needle.In order to overcome the difficulty of operating HABIB PROBE, MEDICAL TAEWOONG, recognized worldwide and Israel as an advanced endoscopic equipment company, developed in cooperation with STARMED an RF needle called EUSRA, which works in conjunction with a VIVO COMBO generator. The function of the generator is to provide up to 200 watts of energy to activate the electrode. The needle can be directly inserted into the pancreas lesion while controlling EUS. At the tip of the needle is a probe that releases the energy at 50W for 10 seconds or 40W until the white bubbles appear in a sonographic image.In recent years, two cases of successful treatment have been reported. In both cases, treatment of neuroendocrine cancer showed good initial results. The first study was performed on a 76-year-old patient with a neuroendocrine tumor.CT performed about one month after the procedure showed complete disappearance of the lesion without any complications. The second study was performed in six patients with an average age of 62. The average diameter of lesion was 3.8 cm. The procedure was successful when two patients felt abdominal pain followed. There were no bleeding events and pancreatitis.This year, a multicenter study was conducted in France in patients with neuroendocrine tumors and cystic lesions in the pancreas, testing the safety and initial efficacy of the method and monitoring for up to 12 months. The study was conducted in a group of 30 patients.In 6 patients with endocrine tumors there was complete disappearance of the lesions, in 3 patients there was a decrease in the diameter of the lesions by more than 50% and in one patient the treatment failed. In 7 of 8 patients with cystic tumors, walled nadies disappeared and in 5 out of 10 patients cystic tumors disappeared. Prophylactic treatment of antibiotics and NSAIDs (anti-inflammatory drugs) and empty the cyst fluid before the procedure led to a dramatic reduction in complications (3.5%). Three patients experienced mild abdominal pain without signs of inflammation successfully treated with paracetamol. (study not yet published).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-01-17 | N/A | 2018-02-11 |
2018-01-24 | N/A | 2018-02-13 |
2018-01-31 | N/A | 2018-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: EUSRA RF electrode new ablation catheter RFA (RADIOFREQUENCY under EUS), developed by TAEWOONG company for the treatment of pancreatic premalignant and early malignant cystic lesion. | DEVICE: EUSRA RF electrode
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of adverse and serious adverse events | The number of subjects with post EUS-RFA-related adverse events including: Fever >38C (will be measured in celcius) | up to one month post-procedure |
| Incidence of adverse and serious adverse events | The number of subjects with post EUS-RFA-related adverse events including: Pancreatitis as measured by an increase of at least 3 times in serum amylase (units/liter) in the initial 72 hours post-procedure | up to 72 hours post-procedure |
| Incidence of adverse and serious adverse events | The number of subjects with post EUS-RFA-related adverse events including: Hemorrhage as measured by need for transfusion of packed red blood cells | up to 72 hours post-procedure |
| Incidence of adverse and serious adverse events | The number of subjects with post EUS-RFA-related adverse events including: Perforation as confirmed by abdominal CT | up to 72 hours post-procedure |
| Incidence of adverse and serious adverse events | The number of subjects with post EUS-RFA-related adverse events including: Mortality | up to 12 months post-procedure |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Absolute disappearance incidence or reduction in lesion size | Direct measuring of lesion diameter and area (in milimeter and milimeter^2 respectively) during the 12-month blind follow-up by EUS, CT and MRI . | up to 12 months post-procedure (3, 6 and 12 months post-procedure) |
| Absolute disappearance incidence or reduction in lesion size | disappearance of mural nodule inside cyst follow-up by EUS, CT and MRI . | up to 12 months post-procedure (3, 6 and 12 months post-procedure) |
| Technical efficiency of the method | To examine the technical efficiency of the method by estimating the frequency of success in performing the operation according to the protocol, without any mishaps and deviations from the original protocol. | during the procedure |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Stanislav Bezobchuk, doctor Phone Number: 04-6495552 Email: Stanislavbe@clalit.org.il |
Study Contact Backup Name: Inbal Reish, SC Phone Number: 04-6495546 Email: inbal_la@clalit.org.il |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
