| CTRI Number |
CTRI/2025/09/094972 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective observational study |
| Study Design |
Other |
|
Public Title of Study
|
To study the complications and safety of the procedures which are performed to burn the tumour cancer cells under anaesthesia |
|
Scientific Title of Study
|
An ambispective observational study of peri operative outcomes in patients undergoing tumour ablation procedures under anesthesia in a tertiary care oncology center in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version 1.1 dated 13.08.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhavi Desai |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819253331 |
| Fax |
|
| Email |
maddes08@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhavi Desai |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819253331 |
| Fax |
|
| Email |
maddes08@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gayathri Vempati |
| Designation |
Post Graduate Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Second floor, Main Building, Tata Memorial Hospital Dr E Borges Road Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
7997566333 |
| Fax |
|
| Email |
vgayathrivempati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, Mumbai 400012 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, Mumbai 400012 India |
| 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 |
| Dr Madhavi Desai |
Tata Memorial Hospital, Mumbai |
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Dr E Borges Road, Mumbai 400012 India Mumbai MAHARASHTRA |
9819253331
maddes08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All Patients posted for tumor ablation (which includes radiofrequency ablation (RFA), cryoablation, microwave ablation and irreversible electroporation (IRE)).
All age groups of patients undergoing tumor ablation techniques under anesthesia, retrospective data from 01 October 2024 to 31 July 2025.
Prospective study will commence from date of institutional ethics committee approval to 30 March 2026
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study intraoperative and postoperative critical events in patients undergoing tumor ablation procedures in Interventional Radiology suite |
1. At the end of the procedure
2. At shifting out from recovery room to ward |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study incidence of postoperative adverse events |
Until POD 3 |
| To study association of critical events with various factors (type of ablation technique, duration of the procedure, age of the patient, ASA physical status comorbidities, stage of disease, intent and extent of procedure, experience of anaesthesiologist) |
Until hospital discharge |
| To study association of adverse events with factors (such as, age, disease status, ASA physical status, intent and extent of procedure, technique of tumour ablation, and comorbidities). |
Until hospital discharge |
|
|
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)
|
30/09/2025 |
| 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
|
Non operating room Anesthesia is exponentially
rising since last two decades and more
complex procedures are being performed
in patients with increasing health issues and in old patients, or in advanced
stage of cancer. These locations are far from safe confines of operating room
complexes of the hospital and are associated with many challenges like lack of trained and skilled personnel, call
for help may take time to arrive, nonavailability of equipment as compared with
main O R. This study focuses on perioperative outcomes in patients undergoing
various tumor ablation procedures in interventional radiology suite. This study aims to observe perioperative and postoperative complications, morbidity and mortality; and find their association with the type of
tumour ablation technique, the technique
of Anesthesia, severity of the disease, extent of procedure and patients
comorbidities. This includes recording preoperative patient’s physical
status, cardiac status and other comorbidities like Diabetes, hypertension,
Thyroid levels etc using different scales. During the procedure, mode of Anesthesia, procedure
related and Anesthesia related complications, and management done for the same will be noted. There is not much literature
available regarding these details
studied before. Outcomes of this study will be
used to improve Anesthesia practices in tumour ablation procedures. |