Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT02343692
Eligibility Criteria:
Inclusion Criteria:
1. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging, for which further surveillance with non-invasive imaging is indicated.
2. Pancreatic cystic tumour between 0.5 and 3cm in size. Cysts greater than 3cm or with mural nodules can be included only if patients are unsuitable for surgical resection.
3. ECOG performance status 0, 1 or 2.
4. Estimated life expectancy of at least 12 weeks.
5. Age \>18 years.
6. Capable of giving written informed consent.
7. Women of child-bearing potential must have a negative pregnancy test (qualitative serum hCG) in the week before treatment, AND be using an adequate contraception method, which must be continued for at least 1 week after RF.
Exclusion Criteria:
1. A diagnosis of a pancreatic cystic tumour where surgical resection is indicated.
2. Pancreatic cysts greater than 3cm or less than 0.5cm in size.
3. Benign pancreatic cysts (e.g. pseudocyst).
4. Serous cystadenomas.
5. Pancreatic cysts with malignant transformation.
6. Cysts involving or in close proximity to vessels or the biliary tree where the zone of ablation is likely to compromise these structures.
7. Cysts arising from the main pancreatic duct.
8. History of active or prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, nonmetastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously).
9. Acute pancreatitis within the previous 4 weeks.
10. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
11. Any psychiatric disorder making reliable informed consent impossible.
12. Pregnancy or breast-feeding.
13. ECOG performance status 3 or 4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02343692
Study Brief:
Protocol Section:
NCT02343692