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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT00124033
Eligibility Criteria:
Inclusion Criteria:
* The patient must be able to give informed consent preoperatively (i.e. elective procedures only)
* Patients at higher than normal risk of having CBD stones identified at OC. For example: \*CBD stones identified at ultrasound; \*Wide CBD (\>6mm) at ultrasound; \*Previous, recent, current cholangitis, jaundice, or biliary pancreatitis; or \*Abnormal AST and ALT levels (\>2 times normal).
Exclusion Criteria:
* Pregnancy at time of surgery
* Patients not fit for surgery. For example: \*Those with acute cholecystitis or persistent obstructive jaundice; \*Patients who have had a previous ERCP and sphincterotomy; or \*Patients in whom intervention was not technically possible (eg. previous Billroth II gastrectomy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00124033
Study Brief:
Protocol Section:
NCT00124033