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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT02882503
Eligibility Criteria:
Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be eligible for this study:
1. Cystic neoplasms in pancreatic parenchyma or outer portion of the pancreas are defined by radiologists who evaluate the images more than twice in three months. The size of benign cystic neoplasm is between 0.5-3 cm. Or surgical specialist physician considers the benign tumor that larger than 3 cm is not suitable for surgery or patients unwilling to accept surgery.
2. Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2 and American Society of Anaesthesiologists (ASA) score ≤ 3.
3. Normal blood coagulation. Platelet count ≥ 100 K/Μl. Prothrombin time (PT)- international normalized ratio (INR) ≦ 1.5.
4. Prior Informed Consent Form.
5. Life expectancy of at least 3 months.
Exclusion Criteria:
* Patients presenting with any of the following will not be enrolled into this study:
1. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
2. To participate in any related tumor therapy clinical trials within thirty days prior to surgery.
3. Any active metal implanted device (eg Pacemaker)
4. Patients who have other malignancies and have not been cured within five years.
5. Patients with resectable pancreatic cancer.
6. Simple pancreatic cysts (including pseudocysts) or serous cystadenoma.
7. Cystic part of the tumor is close to blood vessels or bile duct (\<0.5 cm) that might injury the related structure.
8. Cystic pancreatic tumors originate from or associate the pancreatic ducts.
9. Have acute pancreatitis in the past four weeks
10. Known history of human immunodeficiency virus (HIV) infection
11. Have cardiovascular diseases (such as acute myocardial infarction, or stroke) within the last three months
12. Moderate to severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) \<60)
13. Have any serious or poor control of systemic disease that are not suitable for this test and followup
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02882503
Study Brief:
Protocol Section:
NCT02882503