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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT05750966
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute cholangitis due to common bile duct stones, benign or malignant distal biliary obstruction or distal biliary stent dysfunction (only stents in situ for a minimum of 30 days)
* ERCP with adequate biliary drainage (all common bile duct stones are removed and/or there is adequate flow of clear bile with or without a biliary stent(s))
* Absence of fever (temperature \<38.5°C) or a decrease of body temperature of at least 1°C has occurred within 24 hours after ERCP
* Age ≥ 18 years
* Written informed consent (IC)
Exclusion Criteria:
* Other aetiologies of acute cholangitis (e.g. primary sclerosing cholangitis, (sub)hilar and/or intrahepatic strictures or hilar stents)
* A recurrent cholangitis (within 3 months)
* Patients with surgically altered anatomy (leading to biliary-enteric anastomosis)
* Concomitant pancreatitis, according to International Association of Pancreatology/American Pancreatic Association guidelines.\[18\] Acute pancreatitis is diagnosed in case of fulfilment of 2 out of 3 of the following criteria:
* Upper abdominal pain
* Serum amylase or lipase \>3x ULN
* Signs of acute pancreatitis on imaging
* Concomitant cholecystitis, according to TG18 criteria.\[19\] Acute cholecystitis is suspected in case one item in A is met and one item in B and C.
A. Local signs of inflammation
* A1: Murphy's sign
* A2: Right upper quadrant mass/pain/tenderness B. Systemic signs of inflammation
* B1: Fever
* B2: Elevated C-reactive protein
* B3: Elevated WBC count C. Imaging findings characteristic of acute cholecystitis
* Concomitant liver abscess
* Another additional infectious diagnosis
* Admission on an Intensive Care Unit (ICU) at time of randomisation
* Use of maintenance antimicrobial therapy
* Use of immunosuppressants
* Neutropenia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05750966
Study Brief:
Protocol Section:
NCT05750966