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 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT01587534
Eligibility Criteria:
Inclusion Criteria:
* To be eligible for inclusion, each patient must fulfill each of the following criteria:
1. Subjects with unresectable pancreatic cancer preferably proven by cytology or histology
2. not eligible for surgery because of poor general condition, local unresectability, or advanced disease with metastases
3. Age over 18 years old
4. Performance status (ECOG scale): 0-2
5. Agree to record daily food intake
6. Patients should sign a written informed consent before study entry
Exclusion Criteria:
* Patients will be excluded from the study for any of the following reasons:
1. History of major gastrointestinal surgery
2. history of chronic gastrointestinal disease (for example, Crohn's disease)
3. Diabetes decompensated
4. Diabetes mellitus with severe gastroparesis
5. presence of pancreatic pseudocysts impeding gastric or duodenal passage
6. any use of antacids, mucosal protective agents, H 2 receptor antagonists, or proton pump inhibitors that could not be discontinued
7. concomitant medication affecting gastroduodenal motility (e.g. metoclopramide and erythromycin), or interfering with bile secretion (e.g. bile acids)
8. Abusive use of alcohol in the three months preceding the study;
9. known allergy to pancreatin
10. Any major surgery within 4 weeks prior to study treatment
11. Pregnant or lactating woman
12. Any patients judged by the investigator to be unfit to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01587534
Study Brief:
Protocol Section:
NCT01587534