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:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT03115918
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 19 years
2. The subject (or when applicable the subject's LAR) is capable of understanding and complying with protocol requirements.
3. The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.
4. All patients with acute necrotizing pancreatitis and bedside index for severity in acute pancreatitis (BISAP) score of ≥ 3, who have been referred to Florida Hospital for Percutaneous endoscopy gastrojeunostomy (PEG-J) tube placement and/or ERCP for assessment of the PD
5. Absence of pancreatic fluid collection (defined as those \> 3cm in size located along the course of the main PD on cross-sectional imaging) at the time of study enrollment
6. No disconnected pancreatic duct syndrome (DPDS) on cross-sectional imaging or ERCP
Exclusion Criteria:
1. Age \<19 years
2. Unable to obtain consent for the procedure from either the patient or LAR
3. Patients with acute interstitial pancreatitis, without pancreatic necrosis
4. Patients with BISAP score ≤ 2
5. Patients with pancreatic fluid collection \> 3cm in size located along the course of the main PD on cross-sectional imaging prior to the initial ERCP
6. Patients with DPDS on cross-sectional imaging or ERCP
7. Unable to safely undergo ERCP for any reason
8. Failed cannulation during ERCP
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03115918
Study Brief:
Protocol Section:
NCT03115918