NCT05928286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

December 28, 2022

Last Update Submit

April 17, 2026

Conditions

Gallstone DiseaseObstructive Jaundice

Keywords

Gallstone diseaseObstructive jaundiceRemaxol

Outcome Measures

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.

    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

Secondary Outcomes (14)

  • 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

  • Complication rate in the postoperative period

    Up to 2 weeks

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

    Up to 2 weeks

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

    Up to 2 weeks

  • Interval (in days) between surgical interventions

    Up to 2 weeks

  • +9 more secondary outcomes

Study Arms (2)

The test group

Standard therapy + Remaxol

Drug: Remaxol

The control group

Standard therapy

Interventions

RemaxolDRUG

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

The test group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Krai Clinical Hospital

Barnaul, Russia

Location

Hospital for War Veterans

Kazan', Russia

Location

City Clinical Hospital No. 7

Nizhny Novgorod, Russia

Location

Pavlov Ryazan State Medical University

Ryazan, Russia

Location

Dzhanelidze St. Petersburg Research Institute of Emergency Medicine

Saint Petersburg, Russia

Location

St. Elizabeth Hospital

Saint Petersburg, Russia

Location

Samara State Medical University

Samara, Russia

Location

Mirotvortsev University Clinical Hospital No. 1

Saratov, Russia

Location

Kuvatov Republican Clinical Hospital

Ufa, Russia

Location

MeSH Terms

Conditions

CholelithiasisJaundice, Obstructive

Interventions

Remaxol

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesJaundiceHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

July 3, 2023

Study Start

December 1, 2022

Primary Completion

September 1, 2025

Study Completion

December 31, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(9)