Remaxol® in Malignant Mechanical Jaundice
Jaundice; Malignant
About this trial
This is an interventional treatment trial for Jaundice; Malignant focused on measuring Jaundice, obstructive, Methionine, Succinic acid
Eligibility Criteria
Inclusion Criteria:
- Presence of signed informed consent for participation in the study.
- Men and women over 18 years of age (incl.).
- Demonstrated by one or several instrumental methods (ultrasound, cholangiography, CT or MRI) enlargement of intrahepatic bile ducts with visualized obturation of the main bile ducts caused by tumor.
- Duration of mechanical jaundice less than 30 days, including the first day of the screening period.
- The status by the classifications Eastern Cooperative Oncology Group (ECOG) scale is 0-2.
- Life expectancy of more than 3 months.
Laboratory data corresponding to the following cutoff limits :
hemoglobin ≥90 g / l; neutrophils ≥ 1.5x109 / l; Platelets ≥ 75 x 109 / L; AsAT and / or AlAT above 3 х normal but less than 25 х normal Serum creatinine not exceeding 2 × normal, Serum potassium within normal limits
- Negative urine test for pregnancy in women of reproductive age.
- For reproductive age: consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
Exclusion Criteria:
- Radical surgery planned within 10 days from the date of randomization.
- Liver metastases with the biliary block at the level of segmental ducts.
- Suspicion of metastases in the central nervous system or metastatic arachnoiditis during physical examination; clinically significant ascites.
- Acute destructive pancreatitis, diffuse peritonitis, ongoing bleeding of any etiology, sepsis (procalcitonin test of 10 ng / ml and above).
- Liver cirrhosis
- Presence of clinically significant cardiovascular diseases: chronic cardiac insufficiency III-IV functional class by NYHA, uncontrolled arterial hypertension, acute stroke or acute myocardial infarction in the previous 3 months, unstable angina, uncontrolled arrhythmia and severe heart rhythm disturbances.
- Pregnancy or lactation.
- Hypersensitivity to any component of the study drug / placebo and / or intolerance to any component of the study drug / placebo.
- Regular intake of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment or medical indication tio start any medication prohibited or not permitted by the study protocol
- Concomitant chronic systemic immune or hormonal therapy.
- Gout.
- Alcohol and/or drug dependence.
- Active tuberculosis, HIV infection, syphilis, acute viral hepatitis.
- Any other conditions / diseases that may interfere with the patient's compliance with the requirements of the Protocol.
- Mental, physical and other reasons that do not allow the patient to comply with the requirements of the study protocol.
- Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.
- Participation in any clinical trial in the previous 3 months.
- Staff of the research center and their family members.
Sites / Locations
- GBUZ 'Bryansk City Hospital #1'
- Regional Clinical Hospital of Emergency Care n.a.M.A.Podgorbunsky
- KBUZ 'Regional Clinical Hospital'
- OBUZ 'Kursy Regional Clinical Oncology Dispensary' of Kursky Regional Healthcare Department
- Moscow City Clinical Hospital #1 n.a.N.I.Pirogov
- Moscow City Clinical Hospital #29 n.a.N.A.Bauman
- Omsk Regional Clinical Oncology Center
- GBUZ "Penza Regional Clinical Hospital na N.N.Burdenko"
- City Clinical Hospital of Emergency Care
- GBUZ 'Leningrad Regional Oncology Center'
- GBUZ Leningrad Regional Clinical Hospital
- Hospital for War Veterans
- North-West State Medical University named after I.I. Mechnikov
- Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
- SPb GBUZ "City Hospital №26"
- SPb GBUZ 'City Mariinskaya Hospital'
- OGAUZ "Tomsk Regional Clinical Hospital"
- Siberian State Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Remaxol® 400 ml + Placebo 400 ml
Remaxol® 800 ml
Control
Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Treatment with Remaxol® 800 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Treatment with Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution