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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03085004
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects over the age of 18.
* Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which is consistent with a mucinous type cyst as per ASGE guidelines, including indeterminate type cysts.
* Able to give written informed consent.
* Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Exclusion Criteria:
* Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines (i.e., consistent with a pseudocyst or serous cystadenoma).
* Known or suspected pancreatic cancer or pathologic lymphadenopathy.
* Cysts with the following high-risk features: main pancreatic duct dilation of \> 5mm, epithelial type mural nodules (\> 2mm)33, pathologically thick wall/septation (\> 2mm), cytology showing high grade dysplasia or "suspicious for malignancy", signs of common bile duct or pancreatic duct obstruction, solid mass component within or associated with the cyst (\> 2mm), pancreatic duct stricture associated with tail atrophy, or previous fine needle aspiration failure due to excessive cyst fluid viscosity. (Of note, the following higher-risk features ARE eligible: recent growth in size, atypical cells on cytology, and symptoms referable to the pancreas.)
* Septated cysts with \> 4 compartments.
* Confirmed acute pancreatitis within the last 6 months.
* Baseline lab values (must be within 6 months of consent date) in the following ranges: white blood cells \> 14 or \< 2 K/uL, hematocrit \<30%, platelets \<30 K/uL, non-pharmacologic INR \>1.7, CA19-9 \>2x ULN, lipase \>2x ULN, creatinine \>3.0 mg/dl (unless stable on renal replacement therapy), ALT \>500 U/L, total bilirubin \>2.5 mg/dl.
* Any pre-existing or discovered medical condition that would, at the discretion of the investigator, interfere with the completion of and/or participation in the existing protocol. This includes severe pre-existing medical conditions which would preclude a reasonable 5 year life expectancy (and thus neutralize the patient's benefit from ablating a premalignant type pancreatic cyst).
* Pregnancy, breastfeeding, or incarcerated individual.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03085004
Study Brief:
Protocol Section:
NCT03085004