| CTRI Number |
CTRI/2025/09/094207 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Esophageal and GE Junction Cancer Surgery,Using Special Dyes Instead of Normal Light Helps Surgeons Remove More Lymph Nodes, Which Can Lead to Better Cancer Staging and May Improve Survival Outcomes |
|
Scientific Title of Study
|
Comparison of indocyanine green-near-infrared fluorescence guided lymphadenectomy with conventional white light lymphadenectomy in patients undergoing thoraco laparoscopic esophagectomy for esophageal and gastroesophageal junction cancers- A open label, randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkatesh Paluvadi |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Surgery, 2nd Floor,Hospital block, JIPMER, Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006
INDIA
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8340939602 |
| Fax |
|
| Email |
venkateshpaluvadi888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
raj kumar nagarajan |
| Designation |
additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
ward 34
old block 2nd floor
department of surgery,JIPMER campus
pondicherry
Pondicherry
PONDICHERRY
605006
INDIA
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8340939602 |
| Fax |
|
| Email |
paluvadi984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
raj kumar nagarajan |
| Designation |
additional professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
ward 34
old block 2nd floor
department of surgery,JIPMER campus
pondicherry
Pondicherry
PONDICHERRY
605006
INDIA
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8340939602 |
| Fax |
|
| Email |
paluvadi984@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER INTRAMURAL RESEARCH FUND, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
department of surgery, 2nd floor old block, Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006, INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Venkatesh Paluvadi |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
Department of Surgery, 2nd floor old block, JIPMER Campus Rd, JIPMER Campus, Puducherry, 605006, INDIA
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
8340939602
venkateshpaluvadi888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for observational studies, Jawaharlal institute of postgraduate medical education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K228||Other specified diseases of esophagus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green dye injection |
Indocyanine green dye injection one day prior to surgery followed by lymph node dissection during the esophagectomy using near-infrared camera, and results obtained with the biopsy report. The patient is followed until discharge from the hospital(usually wihin month) |
| Comparator Agent |
No intervention |
Conventional white light based lymphadenectomy during the esophagectomy and results compared with biopsy report(with in 4 weeks) |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted with a diagnosis carcinoma
esophagus & GEJ cancers planned for Thoraco
Laparoscopic esophagectomy |
|
| ExclusionCriteria |
| Details |
1.Patients having iodine or ICG allergy
2.Patients needing emergency surgery
3.Pregnant and lactating females
4. GEJ tumors which are sieverts Type 3 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total number of LNs retrieved in both
groups |
To compare the total number of LNs retrieved during the surgery in both
groups will be assessed at the time of surgery and biopsy report of the specimen, at the time of discharge and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome TimePoints
1.Lymph node positivity rate
2.Post operative complications like thoracic duct injury,
nerve injury etc
3.Post operative length of hospital stay(LOH)
4.Operative time
5.Intraoperative bleeding |
Base line , immediate post operative period, during the hospital stay for any complications, at the end of hospital stay, after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Esophageal cancer (EC) is one of the most aggressive gastrointestinal malignancies. Patients often present with an advanced disease stage, encompassing metastatic lymph nodes or distant metastases, with a 5-year overall global survival rate of 15%–25% .(1, 2)Esophageal cancer ranks as the seventh most common cancer worldwide and the sixth leading cause of cancer-related mortality. Tumor histology, the location of the initial tumor, the T-stage, and neoadjuvant therapy all influence the location of metastatic lymph nodes [3]. Despite advancements in early detection and treatment, EC morbidity and mortality rates remain concerning, largely attributed to lymph nodes (LN). There is no consensus regarding the number of lymph nodes required for adequate staging. Some studies have concluded that the number depends on T staging and others > 23 for appropriate staging.(4) Indocyanine green (ICG) is a water-soluble dye with a molecular weight of 776 Da. ICG- near-infrared (NIR) fluorescence imaging has become a novel surgical navigation technology for surgical treatment. ICG injected into submucosa, travels along the lymphatics to reach the regional lymph nodes. ICG emits green fluorescence which can be identified by near infra-red light. This property of ICG can be explored to gain adequate lymph node retrieval during lymphadenectomy. RATIONALE: Lymph node metastasis is a major prognostic indicator of EC and GastroEsophageal Junction (GEJ) Cancers. Indocyanine green (ICG) ICG-NIR lymphadenectomy helps in easy identification of the draining lymph nodes and potentially increases the yield of number of lymph nodes dissected during esophagectomy. ICG-NIR. may potentially reduce operative time compared to conventional lymph node dissection. NOVELTY: There are only 2 studies comparing the use of the ICG in lymphadenectomy of the esophagus and GEJ cancers. There are no studies done in India. EXPECTED OUTCOME: Lymphadenectomy done using ICG-NIR guidance will increase the number of lymph nodes retrieved, thereby helping in appropriate staging and prognosticating the patient. |