| CTRI Number |
CTRI/2025/03/082525 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
15/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Autofluorescence for intraoperative identification of Parathyroid adenoma. |
|
Scientific Title of Study
|
Accuracy of autofluorescence in Parathyroid adenoma – A diagnostic 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 |
Ayush Gupta |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
All India Institute Of Medical Sciences Delhi, |
| Address |
Room no 423, Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7017474850 |
| Fax |
|
| Email |
ayushgupta.3216@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Brijesh Kumar Singh |
| Designation |
Assistant professor |
| Affiliation |
All India Institute Of Medical Sciences Delhi, |
| Address |
4th floor , Room no 413 Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9354830562 |
| Fax |
|
| Email |
brijeshaiims18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brijesh Kumar Singh |
| Designation |
Assistant professor |
| Affiliation |
All India Institute Of Medical Sciences Delhi, |
| Address |
4th floor , room no 413, Department of Surgical Disciplines, Surgery block, All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9354830562 |
| Fax |
|
| Email |
brijeshaiims18@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 AYUSH GUPTA |
Department of Surgical Disciplines, All India Institute of Medical Sciences |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
7017474850
ayushgupta.3216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D351||Benign neoplasm of parathyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
- patient with parathyroid adenoma
|
|
| ExclusionCriteria |
| Details |
Patients with parathyroid hyperplasia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the clinical utility of Autofluorescence as a technique of intraoperative localization in Parathyroid Adenoma |
1 year 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the auto fluorescence patterns in parathyroid adenoma & normal parathyroid gland during focused parathyroidectomy & hemi or total thyroidectomy respectively using infrared imaging system |
1 year 9 months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
28/03/2025 |
| 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="9"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response (Others) - on request
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - email id of Chief Guide
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response (Others) - 5 years
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
The study is a single institutional diagnostic study, conducted at Department of Surgical Disciplines, AIIMS, New Delhi. The patients included in inclusion criteria will be recruited and will undergo pre-operatively history taking, examination and pre-operative blood investigations (CBC, LFT, RFT, intact PTH, Vitamin D3, serum Calcium), Radiological Investigations like USG-Neck, SESTAMIBI/SPECT, 4D-CT, DEXA Scan, X-Ray forearm. Intra-operatively during parathyroidectomy hemi or total thyroidectomy using Near Infrared Autofluorescence device will be used to identify parathyroid gland . The autofluorescence pattern will be recorded as homogenous or heterogenous. In resected specimens during parathyroidectomy presence of single well defined bright autofluoroscent region will be identified as a cap and indicated with a surgical marker. The specimen of parathyroid will be sent for histopathology and the diagnosis is confirmed. |