CancerNCT04630483
Platelet-lymphocyte and Neutrophil-lymphocyte Ratio in Patients Undergoing Cancer Surgery
An observational study of Cancer and Urologic Neoplasms, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cancer, Urologic Neoplasms, Gynecologic Cancer
- What is being tested?
- INHA and TIVA
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2020to 30 Dec 2022
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: Scheduled for elective cancer surgery (urology, general surgery, gynecologic)
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for elective cancer surgery (urology, general surgery, gynecologic) under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official title: The Effect of Different Anesthesia Methods on the Platelet-lymphocyte and Neutrophil-lymphocyte Ratio in Patients Undergoing Cancer Surgery
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.
Read the 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.
- Conditions
- Cancer, Urologic Neoplasms, Gynecologic Cancer
- Being tested
- INHA, TIVA
- Keywords
- Cancer surgery, Anesthesia, Neutrophil-to-lymphocyte ratio, Platelet-to-lymphocyte ratio
- Medical subject headings
- Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INHAOther
NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values
TIVAOther
NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values
| Study group | Role | What they receive |
|---|---|---|
| Group I: INHA | Inhalational anesthesia (INHA) Receives: Other: INHA | |
| Group II: TIVA | Total intravenous anesthesia (TIVA) Receives: Other: TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of NLR and PLR ratio
Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.
Measured: Average 6 months, through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start23 Nov 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: No participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630483
- Sponsor's protocol ID
- Medipol Hospital 17
- Status last verified
- Apr 2022
- First submitted
- 10 Nov 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
Publications
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.
PubMed 27866303Kim 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.
PubMed 29347949Djordjevic 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.
PubMed 30116146
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Anesthesia Methods on the Platelet-lymphocyte and Neutrophil-lymphocyte Ratio in Patients Undergoing Cancer Surgery
- ClinicalTrials.gov ID
- NCT04630483
- Acronym / sponsor ID
- Medipol Hospital 17
- Conditions
- Cancer, Urologic Neoplasms, Gynecologic Cancer
- Keywords
- Cancer surgery, Anesthesia, Neutrophil-to-lymphocyte ratio, Platelet-to-lymphocyte ratio
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: INHA | – | Other: INHAInhalational anesthesia (INHA) |
| Group II: TIVA | – | Other: TIVATotal intravenous anesthesia (TIVA) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Scheduled for elective cancer surgery (urology, general surgery, gynecologic)
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for elective cancer surgery (urology, general surgery, gynecologic) under general anesthesia
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INHANLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values | Other | Group I: INHA |
| TIVANLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values | Other | Group II: TIVA |
Primary outcome
The value of NLR and PLR ratio
Time frame: Average 6 months, through study completion
Primary aim is to assess the preoperative and postoperative values of inhalational anesthesia vs total intravenous anesthesia.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 27866303Kim 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.
- Background: PubMed 29347949Kim 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.
- Background: PubMed 30116146Djordjevic 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.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Urologic Neoplasms, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The value of NLR and PLR ratio (time frame: Average 6 months, through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04630483, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.