Safety and Efficacy of an Ablation Catheter for the Treatment of Pancreatic Premalignant Cyctic Lesions. (yes)

February 11, 2018 updated by: Stanislav Bezobchuk, HaEmek Medical Center, Israel

A Prospective, Open Label Study: Safety and Efficacy of a New Ablation Catheter RFA (Radiofrequency Under EUS) Developed by TAEWOONG Company for the Treatment of Pancreatic Premalignant and Early Malignant 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-85

    • Patients who agreed to join study and signed an informed consent letter

  • Patients with IPMN pancreas cystic tumor with a diameter greater than 30 mm and with secondary branches.

    • Patients with a tissue component within the cystic lesion
    • Patients with atypical cells in cytology, regardless of the size of the lesion and regardless of the contents of the cyst
    • Patients with a lesion of less than 30 mm diameter showing rapid changes in size (15 mm increments followed by 6 months)
    • Patients with a consistent increase in CEA level within the cyst.
    • Patients with cystinus cystadenoma of any size with suspicious signs such as thickening of the cyst wall, calcification of the cyst wall, irregularity of the cyst wall, tissue content within the cyst, the presence of atypical cells within the cyst in cytology.
    • Symptomatic patients (pain defined as related to the lesion)
    • Asymptomatic patients with a normal cyst greater than 40 mm in diameter.
    • Patients referred for surgical treatment (after the multidisciplinary committee (gastroenterologists, surgeons and pathologists / cytologists) has approved the diagnosis and indication of therapeutic intervention (as is customary) but not suitable for surgery due to high risk of anesthesia (ASAIV) or severe anatomy due to repeat surgery or patients who do not agree to undergo surgical intervention (these are most patients)
    • Patients with low anesthetic risk: ASA 1-3.
    • Women who are not pregnant during recruitment, and women of childbearing age who take birth control during the study.

Exclusion Criteria:

  • Patients with clear evidence of invasive tumor development within the lesion (both candidates and not candidates for continued surgical treatment).
  • Patients with severe coagulation disorders (PT, elongated PTT)
  • Patients with platelet counts less than 75000
  • Patients taking anticoagulants that can not be stopped temporarily
  • Patients with pacemakers
  • Patients with dilatation pages
  • Patients who take clopidogrel in situations that do not allow temporary cessation of the drug.
  • Patients with hight anesthetic risk(ASA4 group).
  • Patients belonging to groups: pregnant women, nursing patients, and demineral patients.
  • Women of childbearing age who do not take birth control.
  • Patients who are unable to express informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

At the tip of the needle there is a probe that releases the peripheral energy in a continuous and continuous manner. The method is a long 50W power release for 10 seconds or 40W until white bubbles appear in a sonographic image.

Materials that come into contact with the body: electrode and grounding surfaces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse and serious adverse events
Time Frame: up to one month post-procedure

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
Time Frame: up to 72 hours post-procedure

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
Time Frame: up to 72 hours post-procedure

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
Time Frame: up to 72 hours post-procedure

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
Time Frame: up to 12 months post-procedure

The number of subjects with post EUS-RFA-related adverse events including:

Mortality
up to 12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute disappearance incidence or reduction in lesion size
Time Frame: up to 12 months post-procedure (3, 6 and 12 months post-procedure)
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
Time Frame: up to 12 months post-procedure (3, 6 and 12 months post-procedure)
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
Time Frame: during the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Stanislav Bezobchuk, doctor, HaEmek Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Anticipated)

February 1, 2018

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0090-17-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD for study protocol will made avilable

IPD Sharing Time Frame

12 months since study completion

IPD Sharing Access Criteria

data access requests will be reviewed by an external independent review panel. Requestors will be requested to sign a data acess agreement

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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