Significance of blood cell counts ratio that is NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio) in predicting Post-operative readmissions, ICU stay and reinterventions and correlate to stage of the disease in final reports in cases of Gastro-intestinal cancers.

Not yet recruiting

• Conditions: Malignant neoplasms of digestive organs,

• Registration Number: CTRI/2023/08/056403
• Lead Sponsor: Dr. Atishay Agarwal

Brief Summary

AIM OF THE STUDY-

To study the Association of inflammatory cellratios PLR  and NLR with respect to Post-operative outcomes and  Pathological TNM staging of cases of Gastro-intestinal   malignancies.

OBJECTIVES OF THE STUDY-

Correlation of inflammatory cell ratio (PLR andNLR) with Tumor Characteristics.

Introduction

Neutrophils and lymphocytes in the tumormicroenvironment constitute a large part of the tumor stroma and the role ofactivated platelets in cancer development and metastasis has been established.

Peripheral blood neutrophil-to-lymphocyte ratio(NLR) and platelet-to-lymphocyte ratio (PLR), which are indicators ofsystemic inflammatory response, are widely investigated as useful predictors and potentialmarkers for prognosis of cancer patients ranging from breast cancersto GI malignancies.

Neutrophils promote cancer proliferation,angiogenesis and metastasis by secreting IL 6, VEGF and PK2/Bv8.

Lymphocytes produce cytokines, which inhibit theproliferation and metastatic spread of cancer cells, and provoke cytotoxic celldeath .

Platelets promotes metastases, due to their abilityto coat tumor cells making them unrecognizable for natural killer cells, alsoproduce VEGF, PDGF, and PF4 ,promote angiogenesis, prevent bleeding from newvessels, leading to tumor cell promotion.

Although the exact mechanism of increased morbiditypost-op is not known.

PLR and NLR associated with prognosis of OverallSurvival in various malignancies, including colon cancer, esophageal cancer,and breast cancer.

Elevated NLR and PLR were associated with largertumor size, higher N stage and deeper tumor invasion, and shorter overallsurvival of GI cancer patients. The NLR and PLR can be used as simple,feasible, inexpensive, and useful parameters to predict staging in patientswith GI cancers

Neutrophils, platelets and lymphocytes playsignificant role in tumor related inflammation and immunology whichpromotes tumour proliferation, metastasis by decreasing apoptosis andincreasing angiogenesis and DNA damage.

Methodology

GI malignancy cases admitted for elective surgeryfrom the initiation of thesis workup will be taken as per the describedcriteria.

Patients who are eligible will be informed aboutthe study background and purpose

Pre-operative parameters including detaileddemographic profile, clinical symptoms with duration, clinical findings, pastmedical and surgical history will be collected.

Histological Diagnosis for particularGastro-intestinal malignancy will be noted.

After obtaining informed consent from the patient,pre-op blood samples will be collected for inflammatory cell ratio within aweek of the surgery.

Peripheral blood samples will be collected forautomated differential counts.

Neutrophil-to-lymphocyte ratio will be calculatedby dividing absolute neutrophil counts with absolute lymphocyte counts.

Platelets-to-lymphocyte ratio will be calculated bydividing platelet counts to absolute lymphocyte counts.

Cut off value of NLR and PLR will be calculatedusing ROC curve.

Patients will be divided into TWO groups based oncutoff values obtained for NLR and PLR from reference studies i.e. high NLR& PLR group and low NLR and PLR group.

Following findings will be noted in post operativefinal histopathology report

1. TNM staging.

2. Tumor grade and differentiation.

3. Lympho-vascular invasion.

4. Lymph node positivity.

5. Perineural invasion.

After surgery correlation between inflammatory cellratio and post-op morbidity & mortality along with pathological TNM stageof resected specimen is checked.

Significant correlation between NLR and PLR andshort term outcomes (Intra and Post operative complications, length of hospitalstay, length of ICU stay) within this period will be noted.

Clinico-pathological association of inflammatorycell ratio ( NLR and PLR) in Gastro-intestinal malignancies will be assessed

Variables

•Age.

•Gender.

•Co-morbidities ( Diabetes, Hypertension, Asthma,COPD and others).

•Pre-operative laboratory values ( Hemoglobin, TLC,DLC, Platelet counts)

•Tumor size, differentiation, positive lymph nodes,and metastatic disease

•Organ/organs involved.

•Laparoscopic or open surgeries.

•Intra-operative events (blood loss, injury tovital structure, duration of surgery).

•Post operative workup ( day 2 ) workup ( TLC, DLCand Platelets).

•Post operative morbidities( Clavien Dindo classification ).

•Post operative mortality within 30 days.

•Lymph node positivity, Early metastasis and Gradesof primary tumor.

Justification for Study

Current modalities to assessing node positivity andmetastatic disease mostly rely on laparoscopy, endoscopy, surgical resection,CT imaging or PET scanning, which lead to increased time betweenidentification of disease extent and initiation of next step of treatment.

The Study will investigate and compare theprognostic impacts of NLR and PLR in patients undergoing surgical resection andexamine the potential role in improving predictive capacity of establishedprognostic nomograms.

These parameters are accessible easily, the cost isnot high, and it may help patients not to delay endoscopic, laparoscopic or useof imaging for screening.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-05-08
• Study Start: 2023-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 1.Resectable Primary GI cancer patients undergoing elective surgery.
• 2.Both open and minimal invasive surgery.
• 3.All patients above 18 years of age.

Exclusion Criteria

• 1.Preoperative radiotherapy and/or chemotherapy.
• 2.Emergency GI malignancy surgeries.
• 3.Concurrent and recent documented systemic infections.
• 4.Patient unfit for surgery.
• 5.Patients on antiplatelet therapy within the previous 3 months.
• 6.Recent Blood transfusion.
• 7.Patients on steroid therapy.
• 9.Patients with blood malignancies and multiple myeloma.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of inflammatory cell ratio (NLR & PLR) with Post-operative Outcomes.	30 days of postoperative period

Secondary Outcome Measures

Name	Time	Method
Pathological TNM stage of GI cancers.
Lympho-vascular involvement.	30 days of postoperative period
Lymph-nodes positivity.
Tumour grade & differentiation.
Short term post-operative outcomes-	1. Length of hospital stay.

Trial Locations

Locations (1)

Kasturba Hospital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital

🇮🇳Udupi, KARNATAKA, India

Dr Atishay Agarwal

Principal investigator

7042121525

atishay.ag@gmail.com