Table 1 Endpoints

Primary endpoint

Composite endpoint of:

Cholangiosepsis (acute cholangitis (Tokyo criteria) and sepsis (Sepsis-3 criteria)

Liver transplantation

Death (whatever occurs first)

Secondary endpoints

Single components of the primary endpoint

Cholangiosepsis

Liver transplantation

Death

Laboratory parameters

Bilirubin, alkaline phosphatase (AP), gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), glutamate dehydrogenase (GLDH), creatinine, C-reactive protein (CRP), cholinesterase (CHE) as change from baseline

Model for end-stage liver disease score (MELD)

MELD as change from baseline

Unplanned hospital admissions

Necessity and days free of hospital care within 6 months

Unplanned intensive care unit (ICU) admissions

Necessity and days free of intensive care unit care, invasive ventilation, renal replacement therapy, vasopressors within 6 months

Necessity of anti-infective treatment

Safety endpoints

Death

Liver transplantation

Cholangiosepsis

Cholangiosepsis-associated septic shock

Acute on chronic liver failure (ACLF)

ACLF of any grade

Unexpected in-patient hospitalization or prolongation of existing hospitalization

Unexpected ICU hospitalization

ERC-related SAEs

Acute post ERC cholangiosepsis, acute post ERC pancreatitis, post ERC bleeding originating from the biliary system, duodenal or biliary perforation, aspiration pneumonia, allergic reaction to sedation associated with endoscopic procedure

Other SAEs

Other potentially life-threatening events as assessed by the individual investigator

Exploratory endpoints

Biliary microbiome

Specific signatures of the biliary microbiome from biliary aspirate

Extent of bile duct damage

Extent of bile duct damage at 6-month MRCP compared to baseline as determined by central radiology reading