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

Polysan

Status: Enrolling

Conditions: Obstructive Jaundice; Gallstone Disease

Treatments: Drug: Remaxol

Study type: Observational

Funder types: Industry

Identifiers

NCT05928286

Remaxol\2022\02

Details and patient eligibility

About

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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

286 participants in 2 patient groups

The test group

Description:

Standard therapy + Remaxol

Treatment:

Drug: Remaxol

The control group

Description:

Standard therapy