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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT01764503
Eligibility Criteria:
Inclusion Criteria:
* Adenoma with at least low grade dysplasia (LGD) was required for inclusion
Two other criteria were needed in asymptomatic patients with LGD :
* an ampullary size \> 1 cm at endoscopy in case of Familial Adenomatous Polyposis (FAP) ;
* two series of positive biopsies in case of sporadic tumors
* uT1N0 lesion at EUS (tumor without invasion of the muscularis propria (MP) of the duodenum and no suspicious lymph nodes)
* without intraductal growth (pancreatic and/or common bile duct)
Exclusion criteria were:
* previously treated ampulloma;
* metastatic disease at CT-scan;
* advanced tumor at duodenoscopy (ulceration or induration involving the duodenal roof of the papilla);
* advanced tumor (uT2 = invasion of the MP without invasion of the pancreas ; uT3 = invasion of pancreas and/or N+ suspicious lymph nodes) and/or intraductal invasion at EUS
* absence of adenoma on the resected specimen.
Exclusion Criteria:
* adenoma not confirmed
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01764503
Study Brief:
Protocol Section:
NCT01764503