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

Not Applicable

Completed

• Conditions: Immunity Factors in Cancer Colon Patients
• Interventions: Procedure: thoracic epidural

• Registration Number: NCT04518579
• Lead Sponsor: South Egypt Cancer Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-15
• Primary Completion: 2020-06-01
• Status Verified: 2020-08
• Study Completion: 2020-08-01
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-19
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
anti tumour immunity	preoperative and Day 1 postoperatively	Venous blood samples are withdrawn. Samples for measurement of percentage of expression of CD8,CD16 and CD56 will be collected in sodium heparin anticoagulant tubes and will be processed according to manufacturer's instructions,and samples for VEGF-C will be centrifuged at 4000 g. Thereafter, the serum will be stored at -22 C for future measurement

Secondary Outcome Measures

Name	Time	Method
change in pain intensity	24 hours postoperative	pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assuit, Egypt