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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT01954602
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Clinical symptoms, laboratory findings and radiological evidences of biliary disease
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Exclusion Criteria:
* Age \<18 yars
* Patients with previous sphincterotomy
* Patients with previous papillary endoscopic balloon dilation
* Presence of a previously placed plastic or metal biliary stent
* Presence of any esophageal or gastro/duodenal stent
* Pancreatic or ampullary cancer, proven by imaging and/or cytology and/or histology, are excluded as PEP is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique (consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)
* Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy
* Presence of a diverticular papilla
* Presence of a duodenal stenosis
* Presence of a pancreas divisum
* Patients with contraindication to endoscopic procedures
* Hemodinynamic instability, any acute illness or exacerbation of chronic illness, acute infections.
* Platelet count less than 50,000/mm3 and INR no greater than 1.5 times upper limit of normal
* Inability or refusal to give informed consent.
* Refusal to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01954602
Study Brief:
Protocol Section:
NCT01954602