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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT05212350
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years
* All patients scheduled for PD for all kind of pancreatic diseases
* Patients able to give their informed consent
* Patients undergoing PD (Kausch-Whipple or Longmire-Traverso)
* Patients presenting two major and at least one minor criteria (Major criteria: Main pancreatic duct diameter ≤3mm; Soft pancreas. Minor criteria: Bleeding stump; Friable stump; Posterior/Eccentric duct; Invisible duct; Deep pancreas; Intraoperative acute pancreatitis; FRS 9-10)
* Two or more surgeons confirming eligibility
* PA or TP with or without spleen preservation (Kimura technique). These techniques are consistent with clinical practice; any other procedure will be a deviation from the protocol
Exclusion Criteria:
* Informed consent withdrawal
* Impossibility to undergo surgery for any reason
* Main pancreatic duct of the pancreatic neck/body \>3mm at preoperative imaging (CT scan or MRI)
* PD not performed for any reason
* Absence of two major criteria
* Absence of at least one minor criteria
* Absence of interobserver agreement between at least 2 surgeons
* More than 1 extension of resection to pancreatic neck due to pancreatic margin positivity
* Wrong randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05212350
Study Brief:
Protocol Section:
NCT05212350