| CTRI Number |
CTRI/2026/02/103597 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparing a dye based blood flow test with the surgeon assessment to prevent flap damage and complications after chest muscle flap surgery in patients with head and neck cancer. |
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Scientific Title of Study
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Evaluation of Indocyanine Green Angiography Versus Clinical Judgment in Reducing Flap Necrosis and Postoperative Morbidity in Pectoralis Major Myocutaneous Flap Reconstruction for Head and Neck Cancer A Randomized Controlled Trial
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shridhar Hosamani |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department Of Surgical Oncology 4th Floor OPD Building AIIMS
Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9582269645 |
| Fax |
|
| Email |
shri7dh@yahoo.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Hemant Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room No 416 Department Of Surgical Oncology 4th Floor OPD Building AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8903306321 |
| Fax |
|
| Email |
hemant.surgicaloncology@aiimsmangalagiri.edu.in |
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Details of Contact Person Public Query
|
| Name |
Dr Hemant Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room No 416 Department Of Surgical Oncology 4th Floor OPD Building AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8903306321 |
| Fax |
|
| Email |
hemant.surgicaloncology@aiimsmangalagiri.edu.in |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Dr Shridhar Hosamani |
| Address |
Department Of Surgical Oncology, 4th Floor, OPD Building, AIIMS
Mangalagiri, Mangalagiri, 522503 |
| Type of Sponsor |
Other [Principal Investigator ] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shridhar Hosamani |
AIIMS,Mangalagiri |
Department Of Surgical Oncology
4th Floor OPD Building
AIIMS Mangalagiri- 522503 Guntur ANDHRA PRADESH |
9582269645
shri7dh@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS MANGALAGIRI |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (2) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (3) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (4) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (5) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (6) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (7) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (8) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (9) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (10) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (11) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (12) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (13) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (14) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (15) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Clinical Judgment group
|
Patients in the control arm will undergo intraoperative and postoperative flap perfusion assessment based on clinical judgment alone, using conventional clinical parameters such as flap color, capillary refill, bleeding from flap edges, and temperature. No intraoperative ICG fluorescence assessment will be used. Standard postoperative monitoring will be done as per institutional protocol. |
| Intervention |
ICG-A group |
Indocyanine green dye Aurogreen from Aurolab Madurai India twenty five milligram will be diluted in ten millilitre of distilled water. A dose of three millilitre corresponding to zero point two to zero point three milligram per kilogram body weight will be administered as a rapid intravenous bolus injection followed immediately by a ten millilitre normal saline jet flush.
An ICG fluorescence imaging system SPY PHI from Stryker San Jose California United States will be used to obtain real time black and white fluorescent images of the PMMC flap to assess vascular perfusion. The camera will be positioned approximately twenty centimetre from the flap surface and the transit of dye through the flap vasculature will be observed and recorded.
ICG fluorescence assessment will be performed in three phases.
Phase one. After flap elevation.
Phase two. After temporary flap rotation and fixation after tunnelling.
Phase three. After final inset of the flap.
A quantitative perfusion assessment of the PMMC flap will be performed by comparing fluorescence intensity with the baseline reference. A relative perfusion of more than thirty five percent of baseline will be considered indicative of adequate flap perfusion.
Perfusion will be graded based on the time taken for dye visualization.
Good perfusion is defined as dye visualization within thirty seconds.
Moderate perfusion is defined as dye visualization between thirty to sixty seconds.
Poor perfusion is defined as dye visualization after more than sixty seconds.
Areas of the flap demonstrating poor perfusion will be identified based on fluorescence demarcation. These poorly perfused areas will be surgically revised along the line of demarcation and the size of the transected area will be measured and documented.
The surgical team will interpret the ICG angiography findings and proceed with final reconstruction using only adequately perfused portions of the PMMC flap. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age greater than eighteen years and less than seventy five years.
2.Histologically confirmed squamous cell carcinoma of the oral cavity.
3.Planned for PMMC flap reconstruction after resection.
4.No known allergy to iodides or ICG dye.
5.Willing to provide informed consent
|
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| ExclusionCriteria |
| Details |
1.Recurrent and Non-resectable head and neck cancers
2.Need for free flap reconstruction.
3.Prior chest wall surgeries or radiation.
4.Patient not fit for surgery
5.Patient not giving consent for participation in this study
6.Patients with diseases with poor healing rates and immunocompromised status
7.Known allergy to iodine or ICG.
8.severe hepatic dysfunction, pregnant/lactating women.
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
Flap-related complications- mainly partial necrosis
1. Flap dehiscence
2. Re-suturing
3. Re-Operations
4. Oro-Cutaneous fistula
|
30 days post operative period |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Starting Orals
2.Hospital stays
3.Starting adjuvant Radiotherapy
|
2 Weeks, 4 weeks & before adjuvant RT |
|
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Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (shri.7.dh@gmail.com).
- For how long will this data be available start date provided 31-08-2028 and end date provided 31-08-2031?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
|
Head and neck cancer surgeries often involve removing parts of the face or mouth and reconstructing them using tissue flaps. One commonly used technique in India is the pectoralis major myocutaneous (PMMC) flap, which is reliable and cost-effective. However, poor blood flow in parts of the flap can lead to serious complications such as tissue death, wound breakdown, infection, or the need for repeat surgery. These issues can delay recovery and postpone important treatments like radiotherapy. Traditionally, surgeons assess flap blood supply during surgery using their clinical judgment—by checking color, bleeding, and temperature. These methods are highly subjective and depend on the surgeon’s experience. As a result, they sometimes fail to detect poorly perfused (low blood flow) areas of the flap. This study introduces Indocyanine Green Fluorescence Angiography (ICG-A), a modern imaging technique that provides real-time, objective visualization of blood flow. ICG is a dye that, when injected into the bloodstream, fluoresces under infrared light. Using a specialized camera, surgeons can see exactly which areas of the flap have good or poor blood supply. This helps them make more accurate decisions about which tissue to keep and which to revise during the operation. By comparing traditional methods with ICG-A in a randomized trial, this study aims to evaluate whether ICG-A can reduce complications, improve flap survival, and support faster postoperative recovery, such as earlier feeding, shorter hospital stays, and timely start of radiotherapy. If successful, this research could help make surgeries safer and more effective, especially in Indian hospitals where PMMC flaps are commonly used, and lead to wider adoption of ICG technology in reconstructive cancer surgery. |