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

Study Overview
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Brief Summary
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Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.

Official Title
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Observational Study of Efficiency of the Drug Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic Acid) Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Conditions
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Gallstone Disease, Obstructive Jaundice

Intervention / Treatment
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* Drug: Remaxol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent form. Age from 18 to 70 years Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice. Total bilirubin level in the blood in the range from 102.5 to 246 µmol/l. Jaundice duration according to the patient is not more than 7 days. Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopic cholecystectomy. Exclusion Criteria: Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.). Acute cholangitis. Acute cholecystitis. Acute pancreatitis. History of chronic viral hepatitis, hepatic cirrhosis. Other surgical pathology aggravating the condition and/or requiring treatment. Use in the treatment of drugs containing ademethionine. CHF, functional class III-IV according to NYHA. History of chronic kidney disease and/or creatinine level of more than 130 µmol/l. Respiratory failure. Impairment of consciousness. Diabetes mellitus. Psychic diseases. Autoimmune diseases. Tuberculosis, HIV infection. Pregnancy, lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The test group<br>Standard therapy + Remaxol | Drug: Remaxol<br>* The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid)<br>|
| The control group<br>Standard therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l and lower by the end of hospitalization | Decrease of total bilirubin level down to 20.5 µmol/l and lower by the end of hospitalization , after successful common bile duct decompression. | Up to 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallstone disease, Obstructive jaundice, Remaxol