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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01521702
Eligibility Criteria:
Inclusion Criteria:
* resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
* T1-3, Nx, M0 (UICC 6th version, 2002)
* infiltration of the portal vein (\<180°) is not an exclusion criterion
* cytologic or histologic confirmation of adenocarcinoma
* age \>18 years
* written informed consent
Exclusion Criteria:
* contraindication for Whipple procedure
* an infiltration \>180° of the portal vein
* abutment of the tumor to the superior mesenteric artery
* infiltration of the superior mesenteric artery or the celiac trunk
* chronic neuropathy \> grade 2
* WHO performance score \>2
* uncorrectable cholestasis (bilirubin \> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
* female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
* pregnant or lactating women
* mental or organic disorders which could interfere with giving informed consent or receiving treatments
* Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
* percutaneous biopsy of the primary tumor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01521702
Study Brief:
Protocol Section:
NCT01521702