Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

• Remaxol (Drug): The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid)

Primary outcomes

• Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1. [Up to 2 weeks]: Decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.

Secondary outcomes

• Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy [Up to 2 weeks]: Decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy, after successful common bile duct decompression.
• Complication rate in the postoperative period [Up to 2 weeks]: Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications
• Total hospitalization duration in days (in case of two-staged surgical treatment). [Up to 2 weeks]: Total hospitalization duration in days
• Total hyperbilirubinemia duration (in days) after the beginning of fluid administration. [Up to 2 weeks]: Total hyperbilirubinemia duration (in days) after the beginning of fluid administration
• Interval (in days) between surgical interventions [Up to 2 weeks]: Interval (in days) between surgical interventions
• Change of hepatic function tests (AST,) [Baseline, on the day after surgery, up to 2 weeks]: Change of hepatic function tests (AST) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of hepatic function tests ( ALT) [Baseline, on the day after surgery, up to 2 weeks]: Change of hepatic function tests (ALT) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of hepatic function test ( AP) [Baseline, on the day after surgery, up to 2 weeks]: Change of hepatic function test ( AP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of hepatic function test (GGTP) [Baseline, on the day after surgery, up to 2 weeks]: Change of hepatic function test (GGTP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of hepatic function tests (protein, albumin, fibrinogen) [Baseline, on the day after surgery, up to 2 weeks]: Change of hepatic function tests (protein, albumin, fibrinogen) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of PTI [Baseline, on the day after surgery, up to 2 weeks]: Change of PTI relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of renal function test (urea) [Baseline, on the day after surgery, up to 2 weeks]: Change of renal function test (urea) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Change of renal function test (creatinine) [Baseline, on the day after surgery, up to 2 weeks]: Change of renal function test (creatinine) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
• Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia. [Up to 2 weeks]: Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

1. Signed informed consent form.
2. Age from 18 to 80 years
3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
4. Total bilirubin level in the blood in the range from 60 to 246 µmol/l.
5. Jaundice duration according to the patient is not more than 7 days.
6. Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopic cholecystectomy.

Exclusion Criteria:

1. Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).
2. Acute cholangitis. Acute cholecystitis. Acute pancreatitis.
3. History of chronic viral hepatitis, hepatic cirrhosis.
4. Other surgical pathology aggravating the condition and/or requiring treatment.
5. Use in the treatment of drugs containing ademethionine.
6. CHF, functional class III-IV according to NYHA.
7. History of chronic kidney disease and/or creatinine level of more than 130 µmol/l.
8. Respiratory failure.
9. Impairment of consciousness.
10. Diabetes mellitus.
11. Psychic diseases.
12. Autoimmune diseases.
13. Tuberculosis, HIV infection.
14. Pregnancy, lactation.