Platelet-lymphocyte and Neutrophil-lymphocyte Ratio in Patients Undergoing Cancer Surgery

Sponsor
Medipol University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04630483
Collaborator
(none)
0
1
25.2
0

Study Details

Study Description

Brief Summary

Cancer is a major cause of morbidity and mortality worldwide. Despite the use of surgery in an attempt to cure the majority of solid tumors, metastasis from residual cancer cells still remains a major cause of morbidity and mortality. General anesthesia and surgical stress during surgery suppress the immune response by directly affecting the immune system or by activating the hypothalamic-pituitaryadrenal axis and the sympathetic nervous system. The aim of our prospective observational study was to assess the value of neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio regarding outcome underwent cancer surgery. Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.

Condition or Disease Intervention/Treatment Phase
  • Other: INHA
  • Other: TIVA

Detailed Description

Cancer is a major cause of morbidity and mortality worldwide. Despite the use of surgery in an attempt to cure the majority of solid tumors, metastasis from residual cancer cells still remains a major cause of morbidity and mortality. As is the case with most cancers, loco-regional recurrence and distant metastases are all too common, even after successful surgical treatment and adjuvant therapy. Cancer metastasis is a complex process in which cancer cells evade the immune system. Cancer cells gain the ability to proliferate, migrate, and invade adjacent tissues, and together with angiogenesis, these capabilities facilitate the successful metastasis of cancer.

General anesthesia and surgical stress during surgery suppress the immune response by directly affecting the immune system or by activating the hypothalamic-pituitaryadrenal axis and the sympathetic nervous system. Along with surgical stress, blood transfusion, hypothermia, and postoperative pain, anesthetics are associated with immunosuppression during perioperative periods because anesthetics/analgesics have direct suppressive effects on cellular and humoral immunity. In general anesthesia, it is suggested that inhalational anesthesia (INHA) such as sevoflurane and isoflurane may modulate antimetastatic immunity by inhibiting NK cell cytotoxicity and inhibit T helper cell proliferation. This could potentially be unfavorable for cancer survival. In contrast, propofol-based total intravenous anesthesia (TIVA) is suggested to have anti-inflammatory features and to be advantageous compared with INHA by promoting the activation of T-helper cells, decreasing matrix metalloproteinases, and not suppressing NK cell activity to the same extend as INHA. The immunological impact of the anesthetic agents may thus influence clinical measures including overall mortality and postoperative recovery. Recently, some readily available parameters, originated from routine complete blood count (CBC), have been investigated as potential biomarkers with mixed results and no consensus so far regarding its accuracy and clinical usefulness: neutrophil-to-lymphocyte ratio (NLR), monocyte-to lymphocyte ratio (MLR), platelet-to-lymphocyte ratio (PLR), and mean platelet volume-to-platelet count (MPV/PC) ratio.

The aim of our prospective observational study was to assess the value of NLR and PLR ratio regarding outcome underwent cancer surgery. Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Different Anesthesia Methods on the Platelet-lymphocyte and Neutrophil-lymphocyte Ratio in Patients Undergoing Cancer Surgery
Actual Study Start Date :
Nov 23, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Group I: INHA

Inhalational anesthesia (INHA)

Other: INHA
NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values

Group II: TIVA

Total intravenous anesthesia (TIVA)

Other: TIVA
NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values

Outcome Measures

Primary Outcome Measures

  1. The value of NLR and PLR ratio [Average 6 months, through study completion]

    Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • American Society of Anesthesiologists (ASA) classification I-II

  • Scheduled for elective cancer surgery (urology, general surgery, gynecologic) under general anesthesia

Exclusion Criteria:
  • Secondary sepsis and/or septic shock with an underlying condition

  • Active infection such as severe peritonitis, pancreatitis, or trauma

  • Long-term ICU stay

  • Preexisting immunodeficiency.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Bagcilar Turkey 34070

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bahadir Ciftci, Principal Investigator, Medipol University
ClinicalTrials.gov Identifier:
NCT04630483
Other Study ID Numbers:
  • Medipol Hospital 17
First Posted:
Nov 16, 2020
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bahadir Ciftci, Principal Investigator, Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022