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Clinical Trials/CTRI/2025/09/094207
CTRI/2025/09/094207Not yet recruitingPhase 3

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

JIPMER1 site in 1 country40 target enrollmentStarted: September 15, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
JIPMER
Enrollment
40
Locations
1
Primary Endpoint
To compare the total number of LNs retrieved in both

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
0.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All patients admitted with a diagnosis carcinoma esophagus & GEJ cancers planned for Thoraco Laparoscopic esophagectomy.

Exclusion Criteria

  • 1.Patients having iodine or ICG allergy 2.Patients needing emergency surgery 3.Pregnant and lactating females
  • GEJ tumors which are sieverts Type 3.

Outcomes

Primary Outcomes

To compare the total number of LNs retrieved in both

Time Frame: 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

groups

Time Frame: 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 Outcomes

  • Outcome TimePoints(1.Lymph node positivity rate)

Investigators

Sponsor
JIPMER
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Venkatesh Paluvadi

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)

Study Sites (1)

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