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

Recruiting

• Conditions: Gallstone Disease; Obstructive Jaundice
• Interventions: Drug: Remaxol

• Registration Number: NCT05928286
• Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2022-12-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. Signed informed consent form.
2. Age from 18 to 70 years
3. Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
4. Total bilirubin level in the blood in the range from 102.5 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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The test group	Remaxol	Standard therapy + Remaxol

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Interval (in days) between surgical interventions	Up to 2 weeks	Interval (in days) between surgical interventions
Total hospitalization duration in days (in case of two-staged surgical treatment).	Up to 2 weeks	Total hospitalization duration in days
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 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 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 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 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 (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.
Complication rate in the postoperative period	Up to 2 weeks	Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications
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.
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
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.

Trial Locations

Locations (9)

Krai Clinical Hospital; 🇷🇺 Barnaul, Russian Federation

Hospital for War Veterans; 🇷🇺 Kazan, Russian Federation

Pavlov Ryazan State Medical University; 🇷🇺 Ryazan, Russian Federation

City Clinical Hospital No. 7; 🇷🇺 Nizhny Novgorod, Russian Federation

St. Elizabeth Hospital; 🇷🇺 Saint Petersburg, Russian Federation

Samara State Medical University; 🇷🇺 Samara, Russian Federation

Mirotvortsev University Clinical Hospital No. 1; 🇷🇺 Saratov, Russian Federation

Dzhanelidze St. Petersburg Research Institute of Emergency Medicine; 🇷🇺 St. Petersburg, Russian Federation

Kuvatov Republican Clinical Hospital; 🇷🇺 Ufa, Russian Federation