Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417843
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Stanislav Bezobchuk, HaEmek Medical Center, Israel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Neuroendocrine Tumor Pancreatic Cyst Pancreatic Cancer Stage Device: EUSRA RF electrode Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A Prospective, open- label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021


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





Primary Outcome Measures :
  1. 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)


  2. 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


  3. 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


  4. 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


  5. 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



Secondary Outcome Measures :
  1. 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 .

  2. 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 .

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417843


Contacts
Layout table for location contacts
Contact: Stanislav Bezobchuk, doctor 04-6495552 ext 972 Stanislavbe@clalit.org.il
Contact: Inbal Reish, SC 04-6495546 ext 972 inbal_la@clalit.org.il

Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Layout table for investigator information
Principal Investigator: Stanislav Bezobchuk, doctor HaEmek Medical Center, Israel

Publications:
Preliminary data of first RFA results of Multicentre study in France (not published). Oral presentation RFA course , Marseille 05.2017.

Layout table for additonal information
Responsible Party: Stanislav Bezobchuk, senior of gasroenterology, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03417843     History of Changes
Other Study ID Numbers: 0090-17-EMC
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for study protocol will made avilable
Supporting Materials: Study Protocol
Time Frame: 12 months since study completion
Access Criteria: data access requests will be reviewed by an external independent review panel. Requestors will be requested to sign a data acess agreement

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stanislav Bezobchuk, HaEmek Medical Center, Israel:
ablation catheter
pancreatic premalignant and early malignant cystic lesion
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Neuroendocrine Tumors
Pancreatic Cyst
Precancerous Conditions
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Cysts