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

NCT ID: NCT04630483

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-23

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Urologic Neoplasms Gynecologic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I: INHA

Inhalational anesthesia (INHA)

INHA

Intervention Type OTHER

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

Group II: TIVA

Total intravenous anesthesia (TIVA)

TIVA

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

INHA

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

Intervention Type OTHER

TIVA

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medipol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bahadir Ciftci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Kim R. Anesthetic technique and cancer recurrence in oncologic surgery: unraveling the puzzle. Cancer Metastasis Rev. 2017 Mar;36(1):159-177. doi: 10.1007/s10555-016-9647-8.

Reference Type BACKGROUND
PMID: 27866303 (View on PubMed)

Kim R. Effects of surgery and anesthetic choice on immunosuppression and cancer recurrence. J Transl Med. 2018 Jan 18;16(1):8. doi: 10.1186/s12967-018-1389-7.

Reference Type BACKGROUND
PMID: 29347949 (View on PubMed)

Djordjevic D, Rondovic G, Surbatovic M, Stanojevic I, Udovicic I, Andjelic T, Zeba S, Milosavljevic S, Stankovic N, Abazovic D, Jevdjic J, Vojvodic D. Neutrophil-to-Lymphocyte Ratio, Monocyte-to-Lymphocyte Ratio, Platelet-to-Lymphocyte Ratio, and Mean Platelet Volume-to-Platelet Count Ratio as Biomarkers in Critically Ill and Injured Patients: Which Ratio to Choose to Predict Outcome and Nature of Bacteremia? Mediators Inflamm. 2018 Jul 15;2018:3758068. doi: 10.1155/2018/3758068. eCollection 2018.

Reference Type BACKGROUND
PMID: 30116146 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Medipol Hospital 17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.