Status:
UNKNOWN
Safety and Efficacy of an Ablation Catheter for the Treatment of Pancreatic Premalignant Cyctic Lesions.
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Pancreatic Cancer
Pancreatic Neuroendocrine Tumor
Eligibility:
All Genders
18-85 years
Phase:
NA
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 ...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03417843
Start Date
February 1 2018
End Date
February 1 2021
Last Update
February 13 2018
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