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CTRI Number  CTRI/2023/08/056403 [Registered on: 10/08/2023] Trial Registered Prospectively
Last Modified On: 05/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   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. 
Scientific Title of Study   Significance of NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio) in predicting Post-operative complications and Pathological outcomes in cases of Gastro-intestinal cancers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Atishay Agarwal 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal 
Address  3rd floor, Department of General Surgery, Smt. Sharda Madhav Pai OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  7042121525  
Fax    
Email  atishay.ag@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh B V 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal 
Address  Dinesh BV, Professor and Unit Chief. Department of General Surgery, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448654410  
Fax    
Email  dinesh.bv@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Raghavendra 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College and Kasturba Hospital, Manipal 
Address  Department of General surgery, division of surgical gastroenterology, KMC, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8725826655  
Fax    
Email  kmc.raghavendra@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba medical college and hospital 
 
Primary Sponsor  
Name  Dr. Atishay Agarwal 
Address  3rd floor, Department of General Surgery, Smt. Sharda Madhav Pai OPD building, Kasturba Hospital, Manipal, Udupi, Karnataka 576104 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atishay Agarwal  Kasturba Hospital  Department of General Surgery; Department of Gastro-Intestinal Surgery; Department of Surgical Oncology, Kasturba Medical College and Hospital
Udupi
KARNATAKA 		 7042121525

atishay.ag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Resectable Primary GI cancer patients undergoing elective surgery.
2.Both open and minimal invasive surgery.
3.All patients above 18 years of age.
 
 
ExclusionCriteria 
Details  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.
8.Recurrent or Metastatic GI cancer.
9.Patients with blood malignancies and multiple myeloma.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of inflammatory cell ratio (NLR & PLR) with Post-operative Outcomes.
 		 30 days of postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Pathological TNM stage of GI cancers.
 		 30 days of postoperative period 
Tumour grade & differentiation.
 		 30 days of postoperative period 
Lympho-vascular involvement.  30 days of postoperative period 
Lymph-nodes positivity.
 		 30 days of postoperative period 
Short term post-operative outcomes-
1. Length of hospital stay.
2. Length of ICU stay.
3. Readmissions & Reinterventions.
 		 30 days of postoperative period 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM OF THE STUDY-

 To study the Association of inflammatory cell ratios 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 and NLR) with Tumor Characteristics.

Introduction

Neutrophils and lymphocytes in the tumor microenvironment constitute a large part of the tumor stroma and the role of activated 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 of systemic inflammatory response, are widely investigated as useful predictors and potential markers for prognosis of cancer patients ranging from breast cancers to GI malignancies.

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

Lymphocytes produce cytokines, which inhibit the proliferation and metastatic spread of cancer cells, and provoke cytotoxic cell death .

Platelets promotes metastases, due to their ability to coat tumor cells making them unrecognizable for natural killer cells, also produce VEGF, PDGF, and PF4 ,promote angiogenesis, prevent bleeding from new vessels, leading to tumor cell promotion.

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

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

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

Neutrophils, platelets and lymphocytes play significant role in tumor related inflammation and immunology which promotes tumour proliferation, metastasis by decreasing apoptosis and increasing angiogenesis and DNA damage.

Methodology

GI malignancy cases admitted for elective surgery from the initiation of thesis workup will be taken as per the described criteria.

Patients who are eligible will be informed about the study background and purpose

Pre-operative parameters including detailed demographic profile, clinical symptoms with duration, clinical findings, past medical and surgical history will be collected.

Histological Diagnosis for particular Gastro-intestinal malignancy will be noted.

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

Peripheral blood samples will be collected for automated differential counts.

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

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

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

Patients will be divided into TWO groups based on cutoff 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 operative final 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 cell ratio and post-op morbidity & mortality along with pathological TNM stage of resected specimen is checked.

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

Clinico-pathological association of inflammatory cell 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 to vital structure, duration of surgery).

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

•Post operative morbidities ( Clavien Dindo classification ).

•Post operative mortality within 30 days.

•Lymph node positivity, Early metastasis and Grades of primary tumor.

Justification for Study

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

The Study will investigate and compare the prognostic impacts of NLR and PLR in patients undergoing surgical resection and examine the potential role in improving predictive capacity of established prognostic nomograms.

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

 

 

 
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