BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis—a study protocol for a multicenter, randomized, controlled parallel group trial

Table 2 Schedule of enrollment, interventions and assessments (SPIRIT figure)

Study phase	Screening	Baseline^a	Treatment			Follow-up
Visit procedures	SCR Day − 28 to day 0	V1 Day 1 (diagnosis SSC)	V2 Week 8 ± 5 days	V3 Week 16 ± 5 days	V4/UN/ET Week 24 (end of treatment) ± 5 days	FU1-FU3 Every 8 weeks ± 5 days
Clinical assessment
Informed consent	x
Eligibility criteria	x
Gender and age	x
Medical history	x
ICU related history	x
Vital signs and oxygen saturation	x	x	x	x	x	x
Height and skin color	x
Weight	x	x	x	x	x	x
Concomitant medication	x	x	x	x	x	x
Pregnancy prevention counseling	x	x	x	x	x
Endoscopic evaluation (ERC)		x	x (intervention group)	x (intervention group)	x (intervention group or clinically necessary for UN/ET)
MRCP^b	x				x
Endoscopic intervention (ERC)		x (endoscopic evaluation only at non-intervention group)	x (intervention group)	x (intervention group)	x (intervention group or clinically necessary for UN/ET)
Randomization		x
Checking the components of the primary endpoint^c			x	x	x	x
Secondary endpoints^d					x
SOFA score		x	x	x	x	x
Serious adverse events		x	x	x	x	x
Laboratory assessment
Hematology	x	x	x	x	x	x
Serum chemistry	x	x	x	x	x	x
Thyroid function test	x
Serum or urine ß-hCG pregnancy testing^e	x	x	x	x	x
Genetic sample	x
Serum/plasma	x	x	x	x	x	x
Bile specimen		x	x (intervention group)	x (intervention group)	x (intervention group or clinically necessary for UN/ET)

^aBaseline/day 1 assessments must be performed prior to treatment
^bMRCP at screening if possible. MRCP at visit 4 may only be performed if MRCP has been conducted during screening (not for unscheduled visit (UN), preferably prior to ERC)
^cThe primary endpoint is defined as occurrence of death or necessity of liver transplantation or occurrence of cholangiosepsis, whatever occurs first
^dSecondary endpoints: single components of the primary endpoint: liver transplantation, death, cholangiosepsis; Laboratory parameters (bilirubin, AP, GGT, AST, ALT, LDH, GLDH, creatinine, CRP, CHE) as change from baseline; model for end-stage liver disease score (MELD) score 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
^eSerum pregnancy testing at screening and urine pregnancy testing during the study for females of childbearing potential only (if urine pregnancy testing is positive, a confirmation with serum pregnancy testing is required)

ISSN: 1745-6215