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

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

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.

Study Overview

• Status: Completed
• Conditions: Immunity Factors in Cancer Colon Patients
• Intervention / Treatment: Procedure: thoracic epidural

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 71511
    • South Egypt Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (EP); Group (EP) received epidural (fentanyl and bupivacaine) - propofol based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)	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; Other Names: thoracic epidural catheter
Active Comparator: Group (EH); Group (EH) received epidural (fentanyl and bupivacaine)- inhalational based anesthetic technique and postoperative analgesia through patient controlled analgesia device (PCA)	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; Other Names: thoracic epidural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Study Chair: samy ab amr, professor, dean of SECI

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No