| 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
|
|
|
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
|
|
|
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. |