| CTRI Number |
CTRI/2021/01/030712 [Registered on: 22/01/2021] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Total number of patients undergoing total thyroidectomy evaluated for postoperative and long term decrease of calcium levels by using intraoperative assessment of parathyroid function with indocyanine green fluoroscence compared with other group assessed by conventional method |
|
Scientific Title of Study
|
Incidence of Postoperative and Long Term Hypocalcemia After Indocyanine Green Fluorescence Guided V/S Conventional Assessment of Parathyroid Function Following Total Thyroidectomy- A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Kumar Mallik |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Surgical Disciplines, CMET office, 1st floor, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9971577854 |
| Fax |
|
| Email |
aviseq@live.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof V Seenu |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Surgical Disciplines, CMET office, 1st floor, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9910834455 |
| Fax |
|
| Email |
seenuneilu04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Kumar Mallik |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Surgical Disciplines, CMET office, 1st floor, AIIMS, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9971577854 |
| Fax |
|
| Email |
aviseq@live.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines, CMET office, 1st floor, AIIMS, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS, Ansari Nagar, New Delhi- 110029 |
| 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 |
| Dr Abhishek Kumar Mallik |
All India Institute of Medical Sciences |
Department of Surgical Disciplines, CMET office, 1st floor, AIIMS, New Delhi-110029
New Delhi
DELHI |
9971577854
aviseq@live.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E07||Disorders of thyroid gland, (2) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Method |
Naked eye view assessment of parathyroid gland after total thyroidectomy |
| Intervention |
Indocyanine Green fluoroscence dye |
ICG will be prepared, according to protocol, the dye mixed with 5 ml sterile water and 2.5 ml injected intravenously. The injection repeated until a maximum dose of 5 mg per kg per day. The catheter flushed after each injection for a rapid image gain. After approximately 1–2min, images acquired using the SPY Fluorescent Imaging system (Novadaq, Ontario, Canada). This system consists of an imaging head equipped with a charge-coupled device camera, a laser light source, and a distance sensor. After thyroid resection, all identified parathyroid glands will be scored visually for viability from grade 0 (no vascularity) to 2 (excellent vascularity), and angiography with ICG will be then performed. The parathyroid glands will appeared in shades of grey depending on the amount of ICG flowing through the parathyroid tissue, thereby reflecting the degree of vascular blood flow |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All Patients undergoing total thyroidectomy for both benign and malignant conditions |
|
| ExclusionCriteria |
| Details |
1. Patients with known renal impairment or iodine allergy
2. Patients with concomitant hyperparathyroidism
3. Age< 18 years Age > 70 years
4. Pregnancy
5. Patients undergoing central compartment neck dissection or modified radical neck dissection
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Parathyroid function and resultant post operative and long term Hypocalcemia in Indocyanine Green Fluorescence Guided V/S Conventional Assessment of Parathyroid Function Following Total Thyroidectomy |
Post operative Day 1, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment for Hypocalcemia in patients undergoing Total Thyroidectomy |
Post operative Day 1, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 2 |
|
Date of First Enrollment (India)
|
31/01/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Identification of parathyroid
glands is one of the main concerns in thyroid surgery. It is usually very
difficult to distinguish parathyroid glands from thyroid and surrounding
tissues in the neck due to their small size and variable location. The
percentage of incidental parathyroidectomies is around 16% The incidence rate
of hypocalcemia can reach up to 4.5% in total thyroidectomies rising to 11.5%
in thyroidectomies with central node dissection. These rates can increase to
50% for transient hypocalcemia and 13.8% for permanent hypocalcemia in total
thyroidectomies. The main cause of hypocalcaemia after total thyroidectomy is
hypoparathyroidism due to intraoperative damage to the parathyroid glands by
trauma, inadvertent parathyroid gland removal or devascularization. The extent
of damage to the parathyroid glands is difficult to predict during surgery. The
feasibility of ICG in assessing the parathyroid gland function in patients
undergoing thyroidectomy and thereby preventing postoperative hypocalcemia is
being compared with our conventional methods in this study |