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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07451392
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (≥18 years) scheduled for elective PPPD due to tumors of the pancreatic head, distal bile duct, or ampulla of Vater.
* Patients with no prior history of gastric surgery or severe gastroparesis.
* Patients with no contraindications to balloon dilatation or intraoperative endoscopic procedures
Exclusion Criteria:
* Patients with prior gastric surgery, pyloric stenosis, or history of severe gastroparesis.
* Patients with severe comorbidities that may preclude safe surgery (ASA class IV or higher).
* Patients who require emergency surgery or have unresectable disease.
* Patients with active gastrointestinal bleeding or severe malnutrition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07451392
Study Brief:
Protocol Section:
NCT07451392