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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT00279292
Eligibility Criteria:
Inclusion Criteria:
3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual) will be included only if the consulting surgeon feels the patients is unresectable based on the CT scan information.
3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at least 1 hour per day.
3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not required unless clinically indicated due to known warfarin use or suspected coagulopathy.
3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain saturation \>90%.
3.5 \> 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7 days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy and radiotherapy allowances.
3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to known or suspected coagulopathy.
3.9 Life expectancy \> 3 months 3.10 Signed and dated informed consent.
Exclusion Criteria:
Unable to sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT00279292
Study Brief:
Protocol Section:
NCT00279292