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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02393703
Eligibility Criteria:
Inclusion Criteria:
* All patients ≥ 18 years of age undergoing pancreaticoduodenectomy, partial or complete pancreatectomy, and duodenal ampullectomy for presumed ductal adenocarcinoma, intraductal papillary mucinous neoplasm (IPMN) or pancreatic neuroendocrine tumors, without an invasive component; or other benign pancreatic disease will be eligible.
* For third part of the study, recipient of neoadjuvant chemotherapy will be accrued to the neoadjuvant group (25 patients). Patients without neoadjuvant chemotherapy will be accrued to the non-neoadjuvant group (25 patients).
Exclusion Criteria:
* The presence of metastatic disease or disease that precludes resection
* For first and second part of the study, receipt of neoadjuvant chemotherapy or radiation for the index cancer within 6 months of being enrolled in the study
* For third part of the study, receipt of neoadjuvant radiation for the index cancer within 6 months of being enrolled in the study
* INR \>2
* Known clotting factor deficiency or hypercoagulable state
* Any patient with the need or anticipated need for full anti-coagulation during hospitalization for the resection.
* Receipt of antiplatelet agents (other than aspirin) in the preceding week prior to resection.
* IPMN or pancreatic neuroendocrine tumors by radiographic imaging with high suspicion for invasive component Additionally, if at the discretion of the operating surgeon, blood collection would lead to undue morbidity, the patient will be excluded and replaced
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02393703
Study Brief:
Protocol Section:
NCT02393703