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CTRI Number  CTRI/2025/12/098487 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Markers of morbidity and death after gall bladder cancer surgery 
Scientific Title of Study   Perioperative Inflammatory and nutritional makers of morbidity and mortality in gallbladder cancer: A Retrospective Study 
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 Sohan Lal Solanki 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room No 210, Dept. of Anaesthesia, Critical Care and Pain, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9869253201  
Fax    
Email  sohan.solanki@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sohan Lal Solanki 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room No 210, Dept. of Anaesthesia, Critical Care and Pain, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9869253201  
Fax    
Email  sohan.solanki@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sohan Lal Solanki 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Room No 210, Dept. of Anaesthesia, Critical Care and Pain, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9869253201  
Fax    
Email  sohan.solanki@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai-400012, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Sohan Lal Solanki 
Address  Room No 210, Dept. of Anaesthesia, Critical Care and Pain, Second Floor, OT Complex, Main Building, Tata Memorial Hospital, Dr E Borges Marg, Parel, Mumbai 400012, India  
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 Sohan Lal Solanki  Tata Memorial Hospital  Room No 210, Operation Theatre Complex, Department of Anaesthesiology Critical care and Pain 2nd floor, Main Building
Mumbai
MAHARASHTRA 
9869253201

sohan.solanki@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Tata Memorial Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients underwent gall bladder cancer surgery from January 2010 to Sept 2022. 
 
ExclusionCriteria 
Details  1. Inoperable cases
2. Patients with missing or incomplete hospital records.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Post-operative complications in terms of Clavien-Dindo Score.  From Postoperative Day 0 to the Day of Discharge.  
 
Secondary Outcome  
Outcome  TimePoints 
30 Day Mortality,
90 Day Mortality,
Disease Free Survival,
Overall Survival and
Fffect of Albumin Globulin Ratio (AGR), Neutrophil to Lymphocyte Ratio (NLR), Platelets to Lymphocyte Ratio (PLR). and Aspartate aminotransferase to Platelet Ratio Index APRI and effect of Delta-AGR, Delta-NLR, Delta-PLR and Delta-APRI on these variables.
 
till 30 day, 90 day, 3 years overall survival and disease free survival 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   15/12/2026 
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="1"
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  

Cancer related malnutrition is extremely common and it has s effect on quality of life, overall survival, disease free survival and recurrence. The patient’s nutritional status has significant impact on immune system, inflammatory response and wound healing process.1 Systemic inflammation is linked to poor prognosis in cancer patients 

Gallbladder cancer (GBC) remains an aggressive malignancy, often discovered late, and with limited prognostic tools beyond standard histopathology. 

 

In recent years, simple blood-based inflammatory markers, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), albumin-to-globulin ratio (AGR), and the systemic immune-inflammation index (SII), have shown potential in anticipating tumour behaviour, postoperative complications, and survival in several cancers.


Albumin is an important marker that reflects nutritional status of a person. It is also an antioxidant, stabilizes cell growth and maintains homeostasis of sex hormones. Many recent studies have shown it to be an independent predictor of overall survival .1 ,2

 

Low levels are seen in chronic inflammation which weakens the defense system and ultimately body becomes susceptible to infection and cytokine induced immune suppression. This eventually leads to recurrence of disease and decreased overall survival.1-4

 

A decreased albumin and high globulin level reflects chronic inflammation (total protein- albumin) and this inflammatory process leads to release of pro inflammatory cytokines which further promotes growth and proliferation of tumor cells.Systemic inflammatory responses also suppresses liver function resulting in decreased albumin synthesis. Many recent studied have shown that increased systemic inflammatory response preoperatively leads to poor   outcome.5

 

Albumin globulin ratio (AGR) which is a combination of albumin and non-albumin, is a better marker than albumin alone because it reflects both malnutrition and inflammation. 4,6,7 Moreover, it is not affected by fluid status like albumin. 

AGR is identified as a simple and useful predictive biomarker for evaluation of post-operative outcomes and survival in several cancers. 

Higher neutrophil to lymphocyte ratio (NLR) and platelets to lymphocyte ratio (PLR) values, in particular, have been repeatedly linked with poorer outcomes, whereas a low AGR may reflect both malnutrition and systemic inflammation, compounding risk. 

Tracking perioperative changes in these markers could offer a dynamic snapshot of the immune response and surgical stress, perhaps allowing earlier intervention. This study will explore their diagnostic and prognostic role in a surgical GBC cohort

Impact of AGR, NLR, PLR and APRI on postoperative outcomes in terms of morbidity and mortality is not studied much in gall bladder cancers, we therefore want to study the impact of these in gall bladder cancers in perioperative period. 

 
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