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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT06162468
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Radiological diagnosis of branch duct IPMN.
* Cyst size of 3cm or worrying growth on serial imaging.
* Suitable to undergo endoscopy under deep sedation or general anaesthesia.
* Willing and able to comply with all trial requirements, including treatment, timing and/or nature of required assessments.
* Signed, written informed consent.
Exclusion Criteria:
* Presence of known or suspected pancreatic cancer or pathologic lymphadenopathy.
* Radiological diagnosis of IPMN with any of the following:
1. Main pancreatic duct dilation of \>10 mm
2. Cytology with high grade dysplasia or "suspicious for malignancy"
3. Common bile duct obstruction causing jaundice
4. Septated cysts with \> 4 compartments
5. Epithelial type mural nodules (\> 2mm)
6. Lesions with thick wall/septation (\> 2mm)
7. High-grade communication with the main pancreatic duct
8. Previous aspiration failure due to excessive cyst fluid viscosity
* Clinically significant laboratory abnormalities
1. INR \>= 1.7
2. APTT \> 80 secs
3. Platelet count \< 100 x 10E9/L
4. ALT \> 500 U/L
5. Total bilirubin \> 25 umol/L
* Evidence of pancreatitis within the last 6 months.
* History of hypersensitivity to gemcitabine or paclitaxel.
* Concurrent illness that may jeopardise the ability of the patient to safely undergo the procedures outlined in this protocol.
* Any medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the protocol.
* Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule, including alcohol dependence or drug abuse.
* Pregnancy, lactation, or inadequate contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06162468
Study Brief:
Protocol Section:
NCT06162468