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NCT Number: NCT05928286

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

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.

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Key information

Conditions

Gallstone Disease Biliary Tract Diseases Cholelithiasis Digestive System Diseases Hyperbilirubinemia Jaundice Jaundice, Obstructive Obstructive Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Krai Clinical Hospital, Barnaul, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent form.
  • Age from 18 to 80 years
  • Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
  • Total bilirubin level in the blood in the range from 60 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.

Treatment and study plan

Remaxol

Drug

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

Primary outcomes

  1. 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.

    Time frame: 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

  1. Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy

    Time frame: 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.

  2. Complication rate in the postoperative period

    Time frame: Up to 2 weeks

    Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications

  3. Total hospitalization duration in days (in case of two-staged surgical treatment).

    Time frame: Up to 2 weeks

    Total hospitalization duration in days

  4. Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.

    Time frame: Up to 2 weeks

    Total hyperbilirubinemia duration (in days) after the beginning of fluid administration

  5. Interval (in days) between surgical interventions

    Time frame: Up to 2 weeks

    Interval (in days) between surgical interventions

  6. Change of hepatic function tests (AST,)

    Time frame: 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.

  7. Change of hepatic function tests ( ALT)

    Time frame: 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.

  8. Change of hepatic function test ( AP)

    Time frame: 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.

  9. Change of hepatic function test (GGTP)

    Time frame: 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.

  10. Change of hepatic function tests (protein, albumin, fibrinogen)

    Time frame: 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.

  11. Change of PTI

    Time frame: 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.

  12. Change of renal function test (urea)

    Time frame: 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.

  13. Change of renal function test (creatinine)

    Time frame: 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.

  14. Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.

    Time frame: Up to 2 weeks

    Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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