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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04400357
Eligibility Criteria:
Inclusion Criteria:
* Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region
* Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease)
* Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver, CT chest, and Cancer Antigen 19-9 is also mandatory.
Exclusion Criteria:
* Body mass index \> 35 kg/m2
* Pregnancy
* Previous history of major abdominal surgery
* Requirement for multivisceral resection (additional surgical resection)
* Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma)
* Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04400357
Study Brief:
Protocol Section:
NCT04400357