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OpenTrials
Completed

NCT Number: NCT04518579

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

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Key information

Conditions

Immunity Factors in Cancer Colon Patients

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Egypt Cancer Institute

Asyut, 71511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: thoracic epidural catheter

Primary outcomes

  1. anti tumour immunity

    Time frame: 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    Venous blood samples are withdrawn.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 outcomes

  1. change in pain intensity

    Time frame: 24 hours postoperative

    pain intensity measured by Visual analogue scale from 0 to 10 where 0 no pain and 10 is sever pain

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Registry information

Official study title

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

Acronym: tumorimmunity

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.