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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03921502
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic choledocholithiasis (choledocholithiasis demonstrated radiologically or highly suspected by clinical data (acute cholangitis or obstructive jaundice), analytical and imaging according to the criteria of high probability of choledocholithiasis established in the clinical guidelines (ASGE Guide).
* Discarded for surgical treatment due to age, comorbidity or refusal of the patient.
* Age\>75 years
Exclusion Criteria:
* Charlson comorbidity scale adjusted to age \<4.
* Hepatobiliary surgery or previous superior digestive tract.
* Ascitis.
* Inability to tolerate sedation of endoscopy, perforation of the digestive tract or other contraindication to endoscopy.
* Coagulopathy with INR (international normalized ratio) \> 1.5 not correctable or thrombocytopenia \<50000 / mm3 not correctable.
* Other diagnoses at admission (acute cholecystitis, acute pancreatitis, biliopancreatic neoplasia).
* Hemodynamic instability.
* Urgent procedure performed after hours
* No availability of expert material / endoscopist in drainage.
* Anatomical impossibility of performing biliary drainage (absence of vesicular distension, contact between gallbladder and stomach or duodenum, contact area \<10 mm).
* Baseline ECOG (Easthern Cooperative Oncology Group) \> = 4
* Expectancy of survival \<6 months.
* Refusal to participate.
* Distance between the gallbladder and upper digestive tract\> 1cm, scleroatrophic vesicle, lack of stable acoustic window for drainage
* ERCP failed (inhability to dain common bile duct)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT03921502
Study Brief:
Protocol Section:
NCT03921502