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

NCT03417843 | Unknown DMC

• 1 other identifier: 0090-17-EMC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer; Pancreatic Neuroendocrine Tumor; Pancreatic Cyst; Pancreatic Cancer Stage

Keywords

ablation catheter; pancreatic premalignant and early malignant cystic lesion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Absolute disappearance incidence or reduction in lesion size

  up to 12 months post-procedure (3, 6 and 12 months post-procedure)

• Absolute disappearance incidence or reduction in lesion size

  up to 12 months post-procedure (3, 6 and 12 months post-procedure)

• Technical efficiency of the method

  during the procedure

Study Arms (1)

EUSRA RF electrode

EXPERIMENTAL

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

Interventions

EUSRA RF electrode DEVICE

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

EUSRA RF electrode

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Related Publications (20)

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

  BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenoma, Islet Cell; Pancreatic Cyst

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Cysts

Study Officials

• Stanislav Bezobchuk, doctor

  HaEmek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanislav Bezobchuk, doctor

CONTACT

04-6495552; Stanislavbe@clalit.org.il

Inbal Reish, SC

CONTACT

04-6495546; inbal_la@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior of gasroenterology

Model Details: A Prospective, open- label study

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 31, 2018
• Study Start: February 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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