Status:
NOT_YET_RECRUITING
Effect of Lidocaine or Dexamethasone on Cancer Immune Response- the PILDI Study
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Colon Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
There are very few data in the literature on changes in inflammatory markers when lidocaine or corticosteroids are administered perioperatively in patients with colorectal cancer. In patients undergoi...
Detailed Description
In 80% of cancer patients, surgery is indicated during treatment. The choice of anasthetic technique can indirectly influence the patient's inflammatory and immune systems. Although a large body of da...
Eligibility Criteria
Inclusion
- colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed,
- age of patients between 18 and 80 years,
- low to moderate risk of anesthesia (ASA up to and including 3),
- ability to understand the study and to sign an informed consent to participate in the study
Exclusion
- patients receiving neoadjuvant chemotherapy,
- pregnancy or breastfeeding,
- known allergy to lidocaine
- cardiac rhythm disturbances (bradycardia \< 45 beats/min, complete heart block, use of group III antiarrhythmics),
- status post cardiac arrest,
- porphyria,
- myasthenia gravis,
- severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy),
- renal disease (hamodialysis, creatinine clearance \<30 mL/min),
- epilepsy,
- allergy to dexamethasone,
- active infection,
- presence of viral or systemic fungal disease,
- uncontrolled psychotic state,
- ulcerative gastric or duodenal disease,
- chronic corticosteroid therapy.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06923787
Start Date
November 1 2025
End Date
May 1 2028
Last Update
April 11 2025
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000