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

NCT04518579 | Completed DMC

• 1 other identifier: 375
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunity Factors in Cancer Colon Patients

Outcome Measures

Primary Outcomes (1)

• 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  Venous blood samples are withdrawn.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 Outcomes (1)

• change in pain intensity

  24 hours postoperative

Study Arms (2)

Group (EP)

ACTIVE COMPARATOR

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

Procedure: thoracic epidural

Group (EH)

ACTIVE COMPARATOR

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

Procedure: thoracic epidural

Interventions

thoracic epidural PROCEDURE

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

Also known as: thoracic epidural catheter

Group (EH); Group (EP)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 71511, Egypt

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• samy ab amr, professor

  dean of SECI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Group (EP) received epidural - propofol based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia and Group (EH) received epidural- inhalational based anesthetic technique and postoperative analgesia through patient controlled epidural analgesia

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 19, 2020
• Study Start: April 15, 2018
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)