The influence of shunting left/right portal vein branch on post-TIPS hepatic encephalopathy: a study protocol for multicenter randomized blinded controlled trial

Table 2 Trial assessment schedule

	Enrollment	Treatment			Post-TIPS follow-up
Evaluation/examination	≤14 days before randomization	D0	D1	D2	M1	M3	M6	M12	M18	M24
Informed consent	×
Demographics	×
Medical History	×
Enhanced abdominal CT	×			×		×		×		×
Ultrasound Elastography	×			×	×	×	×	×	×	×
Upper gastrointestinal endoscopy	×				×	×	×	×	×	×
Hematology^a	×	×	×		×	×	×	×	×	×
Biochemistry^b	×		×		×	×	×	×	×	×
Serial ammonia concentration	×		×		×	×	×	×	×	×
Tumor markers^c	×		×		×	×	×	×	×	×
HBV-DNA	×		×		×	×	×	×	×	×
Child-Pugh	×		×		×	×	×	×	×	×
MELD^d	×		×		×	×	×	×	×	×
ECOG^e	×	×	×	×	×	×	×	×	×	×
HE assessment^f	×	×	×	×	×	×	×	×	×	×
Adverse events	×	×	×	×	×	×	×	×	×	×
Survival	×	×	×	×	×	×	×	×	×	×

^aMeasurement of red blood cells, hemoglobin, white blood cells, absolute neutrophils and absolute lymphocytes,and platelets
^bMeasurement of total bilirubin, direct and indirect bilirubin, albumin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, glutamine transferase, urea nitrogen, serum creatinine, potassium, sodium, prothrombin time, INR, and D-dimer
^cMeasurement of AFP, CEA, and CA-199
^dModel for End-stage Liver Disease scores
^eEastern Cooperative Oncology Group
^fMeasured by Stroop Test and clinical examination

ISSN: 1745-6215