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

Immunity Factors in Cancer Colon Patients Clinical Trial

— tumorimmunity  

Official title:

Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518579
• Other study ID #: 375
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: South Egypt Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Immunity Factors in Cancer Colon Patients

Intervention

Procedure:
• thoracic epidural
undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
South Egypt Cancer Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti tumour immunity	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	preoperative and Day 1 postoperatively
Secondary	change in pain intensity	pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain	24 hours postoperative