NCT07432399RecruitingPhase 2
Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
Effect of Perioperative Intravenous Infusion of Lidocaine or High Dose Dexamethasone on the Immune Response in Patients Undergoing Surgery for Colon Cancer - The PILDI Study
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Institute of Oncology Ljubljana
- Diseases
- Colorectal cancer
- NCT number
- NCT07432399
- EU CT number
- 2025-521808-22-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Sept 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients
- Severe hepatic impairment
- Severe renal impairment
- Severe cardiac conduction disorders or clinically significant arrhythmias
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation
Other
- Pregnancy or breastfeeding
- Severe uncontrolled comorbidities that could interfere with study participation
- Participation in another interventional clinical trial that could influence study outcomes
Who the study is looking for
- Adult patients aged 18 years or older
- Histologically confirmed colon cancer
- Scheduled for elective surgical resection of colon cancer
- Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol
- Ability to understand the study procedures and provide written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Oncology Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.