Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon (tumorimmunity)

South Egypt Cancer Institute

Status: Completed

Conditions: Immunity Factors in Cancer Colon Patients

Treatments: Procedure: thoracic epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT04518579

375

Details and patient eligibility

About

Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.

Enrollment: 48 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 20-70 yrs.
• ASA class I and II
• Elective open surgery for non-metastatic cancer colon stage I,II

Exclusion criteria

• Patient refusal
• Known allergy to the study medications
• Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids)
• Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Group (EP)

Active Comparator group

Description:

Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)

Treatment:

Procedure: thoracic epidural

Group (EH)

Active Comparator group

Description:

Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)

Treatment:

Procedure: thoracic epidural