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Prevention and Treatment of Complications of Endovascular Methods in Patients With Malignant Liver Tumors (PATOC)

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ClinicalTrials.gov Identifier: NCT04764409
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Stukalova Oksana Yuryevna, Central Clinical Hospital RZD-Medicine, Russian Federation

Study Description
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Brief Summary:

In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors does not exceed 6%. The main and radical method of treatment today is liver resection. However, surgical treatment is possible only in 10-25% of patients. At the same time, recurrence of malignant tumors is observed in 60-80% of cases within five years after surgery, and the number of candidates for repeated liver resection does not exceed 10%. The high toxicity of systemic chemotherapy limits its use in this group of patients. In this connection, minimally invasive and at the same time effective methods of local treatment of malignant liver tumors have been introduced into clinical practice. These methods include: hepatic artery chemoinfusion, chemoembolization and oil chemoembolization.

Currently, a large world experience has already been accumulated in the application of the above methods of treatment. However, any, even minimally invasive, surgical manipulation can be associated with the development of complications of varying severity. If complications arise, there is a risk of interruption of palliative care, which entails a significant reduction in life expectancy. According to domestic and foreign literature, the occurrence of complications after intra-arterial chemoembolization occurs in 0.4-10% of patients, and after intra-arterial chemoinfusion - in 5-30% of patients. In the overwhelming majority of scientific works, the description of the complications that have arisen is reduced to listing the latter. Currently, in the Russian and foreign scientific literature there is no systematization of complications, there is no single clinical classification, algorithms for the prevention and treatment of complications arising after local intravascular methods of treatment of patients with malignant liver tumors.

The study and systematization of complications arising after intra-arterial chemoembolization and chemoinfusion of the hepatic artery in patients with malignant liver tumors will make it possible to create prevention and treatment algorithms. Thus, it will help prevent interruption of palliative care and increase the life expectancy of this cohort of patients.


Condition or disease Intervention/treatment
Hepatic Cancer Metastatic Cancer Chemotherapy Effect Procedure: Chemoembolization Procedure: Chemoinfusion

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention and Treatment of Complications of Endovascular Methods in Patients With Malignant Liver Tumors
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : December 12, 2022
Estimated Study Completion Date : December 12, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
This group includes patients who underwent chemoembolization of hepatic arteria
 Procedure: Chemoembolization
Transarterial Chemoembolization (TACE)
Group 2
This group includes patients who underwent chemoinfusion of hepatic arteria
 Procedure: Chemoinfusion
Transarterial Infusion (TAI)


Outcome Measures
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Primary Outcome Measures :
  1. Identification of all the kinds of complications according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and their systematization. [ Time Frame: 2 years ]
    This systematization will lead to the creation of algorithms of prevention and treatment of complications of endovascular methods in patients with malignant liver tumors. For the assessment of the severity of complications there will be created a new scale.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study is planned to include patients with primary liver cancer and metastatic liver disease, after chemoembolization or chemoinfusion of the hepatic artery.
Criteria

Inclusion Criteria:

  1. Aged over 18 years old;
  2. Histologically confirmed diagnosis of liver cancer or metastatic liver disease;
  3. Patients who have not received systemic antitumor therapy within the last 6 months

Exclusion Criteria:

  1. Metachronous (within 3 years) or synchronous other oncological disease with the exception of healed carcinoma in situ;
  2. The volume of liver damage according to computed tomography is more than 60%;
  3. Increase in the level of transaminases by more than 2 times;
  4. The level of bilirubin is more than 50 μmol / l;
  5. Heart failure stage II B-III, Functional Class III-IV;
  6. The presence of uncorrected coagulopathy;
  7. Renal failure stage III-IV;
  8. Ascites 2-3 degrees;
  9. The general condition of the patient is below 60% on the Karnofsky index and above 2 points on the Eastern Cooperative Oncology Group (ECOG) scale;
  10. Liver damage - more than 7 points on the Child-Pugh scale;
  11. Damage to the central nervous system;
  12. Anemia of severe severity;
  13. Pregnancy;
  14. Active autoimmune disease;
  15. Presence of HIV infection, active forms of tuberculosis;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764409


Contacts
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Contact: Oksana Stukalova, Postgraduate +79852138906 docstukalova@mail.ru

Locations
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Russian Federation
Central Clinical Hospital RZD-Medicine, Russian Federation Recruiting
Moscow, Moscow's Oblast, Russian Federation, 129128
Contact: Oksana Stukalova, postgraduate    +79852138906    docstukalova@mail.ru   
Contact: Roman Ishenko, Professor    +79260878506    ishenkorv@rambler.ru   
Sponsors and Collaborators
Central Clinical Hospital RZD-Medicine, Russian Federation
More Information
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Responsible Party: Stukalova Oksana Yuryevna, Principal Investigator, Central Clinical Hospital RZD-Medicine, Russian Federation
ClinicalTrials.gov Identifier: NCT04764409    
Other Study ID Numbers: CCHRZD00001
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stukalova Oksana Yuryevna, Central Clinical Hospital RZD-Medicine, Russian Federation:
Chemoembolization
Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases