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Clinical Trials/CTRI/2025/09/094972
CTRI/2025/09/094972Not yet recruitingNot Applicable

An ambispective observational study of peri operative outcomes in patients undergoing tumour ablation procedures under anesthesia in a tertiary care oncology center in India

Tata Memorial Hospital1 site in 1 country150 target enrollmentStarted: September 30, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
150
Locations
1
Primary Endpoint
To study intraoperative and postoperative critical events in patients undergoing tumor ablation procedures in Interventional Radiology suite

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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
  • Prospective study will commence from date of institutional ethics committee approval to 30 March 2026.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To study intraoperative and postoperative critical events in patients undergoing tumor ablation procedures in Interventional Radiology suite

Time Frame: 1. At the end of the procedure | 2. At shifting out from recovery room to ward

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Madhavi Desai

Tata Memorial Centre

Study Sites (1)

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