| CTRI Number |
CTRI/2025/04/084851 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Surgical Approaches for Brain Tumors with Fluid Buildup: Endoscopic procedure vs Open Shunt procedure |
|
Scientific Title of Study
|
Endoscopic Third Ventriculostomy versus Ventriculoperitoneal Shunt followed by definitive surgery in Infratentorial tumours with hydrocephalus– A prospective randomized control study |
| Trial Acronym |
EVASION |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshitij Raj Mahajan |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Dept of Neurosurgery
AIIMS Jodhpur, Basni
Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7838232999 |
| Fax |
|
| Email |
kshitijrajmahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikas Janu |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Dept of Neurosurgery Neurosurgery OPD Room no. 46, Block-C, Ground Floor, OPD Building
AIIMS Jodhpur, Basni
Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9727713917 |
| Fax |
|
| Email |
vjanu17587@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshitij Raj Mahajan |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Dept of Neurosurgery
AIIMS Jodhpur, Basni
Jodhpur Rajasthan
RAJASTHAN
342005
India |
| Phone |
7838232999 |
| Fax |
|
| Email |
kshitijrajmahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
AIIMS Jodhpur
Basni Jodhpur Rajasthan
342005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Kshitij Raj Mahajan |
AIIMS Hospital Jodhpur |
Dept of Neurosugery, Neurosurgery OPD Room no. 46, Block-C, Ground Floor, OPD Building
AIIMS Jodhpur, Basni
Jodhpur Rajasthan 342005
Jodhpur
RAJASTHAN |
7838232999
kshitijrajmahajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic Third Ventriculostomy |
Endoscopic Cerebrospinal fluid diversion in posterior fossa tumors with Hydrocephalus |
| Comparator Agent |
Ventriculoperitoneal Shunt |
Traditional open technique of Cerebrospinal fluid diversion in posterior fossa tumors with Hydrocephalus |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) All Patients with single Infratentorial brain tumour with radiological and clinical features of hydrocephalus on presentation.
2) Patients who give written informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
1) Multicentric tumours
2) Patients less than 6 months of age.
3) Patients with posterior fossa tumours without clinical and radiological features of hydrocephalus
4) Recurrent lesions
5) Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate of the two CSF diversion procedures prior to definitive surgery in patients of Infratentorial tumours with hydrocephalus on the basis of development of pseudomeningocele, CSF leak and need for revision of the CSF diversion procedure postoperatively. |
Baseline on admission and follow-up at 3 months if uneventful or as and when needed in case of emeregency |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To determine the complications in each group of patients.
• To check for the functional outcome in each group
|
Baseline on admission, follow-up at 3 months if uneventful or as & when required in case of emergency |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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 Yet Recruiting |
| 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
|
The study has been proposed with the aim to study and decide the standard of care for patients suffering with Infratentorial tumours with hydrocephalus requiring CSF diversion procedure preoperatively in the form of Endoscopic Third Ventriculostomy or Ventriculoperitoneal Shunt and do a comparative analysis as to which procedure is more beneficial in the study population. The proposed study was not done previously in the institute as well as in any institute as far as my understanding and research. This study can help us to understand the implications, pros, and cons of both of the CSF diversion procedures and help in deciding which procedure to be followed as per the results of the research. |