| CTRI Number |
CTRI/2025/10/096423 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on short-term recovery results after liver surgery at a major cancer hospital |
|
Scientific Title of Study
|
Evaluation of Short-Term Postoperative Outcomes After Liver Resections in a Tertiary Cancer Institute -An observational 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 |
malini joshi |
| Designation |
professor |
| Affiliation |
actrec, tata hospital, khargar |
| Address |
6th floor, RRS building, Department of anaesthesia and icu
Actrec hospital,Tata memorial centre, khargar , navi mumbai
6th floor, RRS building, Department of anaesthesia and icu
Actrec hospital,Tata memorial centre, khargar , navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
malini joshi |
| Designation |
professor |
| Affiliation |
actrec, tata hospital, khargar |
| Address |
6th floor, RRS building, Department of anaesthesia and ICU, Actrec hospital, Tata memorial centre, khargar , navi mumbai
6th floor, RRS building, Department of anaesthesia and ICU, Actrec hospital, Tata memorial centre, khargar , navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
malini joshi |
| Designation |
professor |
| Affiliation |
actrec, tata hospital, khargar |
| Address |
6th floor, RRS building, Department of anaesthesia and ICU, Actrec hospital, Tata memorial centre, khargar , navi mumbai
6th floor, RRS building, Department of anaesthesia and ICU, Actrec hospital, Tata memorial centre, khargar , navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Actrec hospital, TATA memorial centre
khargar, navi mumbai |
|
|
Primary Sponsor
|
| Name |
N.A |
| Address |
N.A |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| malini joshi |
ACTREC hospital |
6th floor,RRS buiding, departemnt of anaesthesia and icu, actrec, tata memorial centre, khargar, navi mumbai
Raigarh
MAHARASHTRA |
9987226657
jmalini2007@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C229||Malignant neoplasm of liver, not specified as primary or secondary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Our inclusion criteria includes Adult patients (age 18 years or older) undergoing elective liver resection (major or minor) for malignant lesions. |
|
| ExclusionCriteria |
| Details |
Our exclusion criteria includes emergency liver resections and patients not consenting for the surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of Clavien-Dindo complications 3-4 following hepatectomies( both major and minor) |
To assess the incidence of Clavien-Dindo complications 3-4 following hepatectomies( both major and minor) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the association between morbidity predictors and the outcome variables such as duration of mechanical ventilation (MV), length of stay (LOS) in ICU, LOS in hospital, hospital re-admission within 30 days of discharge, 30-day mortality rate, 90-day mortality rate |
30 day morbidity and 90 day mortality follow up |
| To assess the effect of Pringles maneuvre on the postoperative outcomes |
30 days post operative |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/11/2025 |
| 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
|
liver resection continues to play a vital role in the curative treatment of both primary and secondary liver cancers. Although there have been significant advances in surgical methods and perioperative care, rates of morbidity and mortality remain considerable, particularly in patients with pre-existing liver dysfunction or those undergoing extensive resections. identifying factors linked to short term (within 30 days) postoperative outcomes is esssential for improving risk assessment, optimizing perioperative care, and guiding patient discussions. this study is designed to determine the clinical, pathological, and surgical predictors of poor short-term outcomes in patients who undergo liver resections at high-volume tertiary cancer centre. The study will be a combination of prospective and retrospective observational cohort designs, and it will be conducted at ACTREC, tata memorial centre. prospective data will be gathered over a 1 year period from the date of ethics approval (25/9/25), while retrospective data will be collected starting from 1/6/24 till 1/6/25. the study will analyse how perioperative factors, including those related to anesthesia and surgery, affect 30-day postoperative outcomes in liver resection cases. the study population will consist of adult patients (aged 18 and above) who are scheduled for elective liver resections (either major or minor) for malignant tumors. upon admission for surgery, patients will undergo fitness assessments, and written informed consent will be obtained. Patient data will be extracted from electronic medical records (EMR) and case files. postoperative complications will be recorded until the time of discharge and monitored during the 30-day follow-up period, while mortality will be tracked for upto 90 days post-surgery. |