A Study of Special Green Dye Guidance for Lymph Node Removal During Keyhole Surgery for Stomach Cancer

Fluorescent guided lymphadenectomy with Indocyanine green in laparoscopic gastrectomy for Gastric Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106911

Enrollment

120

Registered

2026-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C168- Malignant neoplasm of overlappingsites of stomach

Interventions

Intervention1: Patients randomized to Arm A will undergo laparoscopic gastrectomy with D2 lymphadenectomy using indocyanine green (ICG) fluorescence guidance.: ICG will be prepared at a 0.5 mg/mL conc

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years. 2. Histologically confirmed gastric adenocarcinoma (cT1-T4a, N0/+, M0 per AJCC 8th ed.). 3. Eligible for curative laparoscopic subtotal/total gastrectomy with D2 lymphadenectomy. 4. ECOG performance status 0-1. 5. Adequate organ function. 6.Signed informed consent.

Exclusion criteria

Exclusion criteria: Known allergy or hypersensitivity to indocyanine green or iodine. Previous gastric surgery that alters normal gastric anatomy. Patients requiring emergency surgery. Presence of distant metastasis or patients undergoing surgery with palliative intent. Pregnant or breastfeeding women. Severe comorbid illness with American Society of Anesthesiologists physical status class greater than three. Diffuse type gastric cancer including signet ring cell carcinoma or poorly cohesive carcinoma with linitis plastica or involvement of the whole stomach. Tumor involving more than seventy five percent of the stomach surface on diagnostic laparoscopy. Suspected or confirmed peritoneal carcinomatosis detected on CT scan, PET CT, or diagnostic laparoscopy.

Design outcomes

Primary

Measure	Time frame
To evaluate the superiority of ICG fluorescence-guided lymphadenectomy in increasing the total number of retrieved LNs during laparoscopic D2 gastrectomy for gastric cancer.Timepoint: Baseline (Intraoperatively)	—

Secondary

Measure	Time frame
Assess nodal noncompliance rate (per Japanese Gastric Cancer Association [JGCA] guidelines).Timepoint: Baseline (Intraoperatively);Compare operative time, blood loss, hospital stay, & cost.Timepoint: baseline (Intraoperatively);Determine fluorescence detection rate for metastatic LNs (pathology correlation).Timepoint: Baseline (Intraoperatively)	—

Countries

India

Contacts

Public ContactSyed Nusrath

Basavatarakam Indo American Cancer Hospital and Research Institute

drnusrath@basavatarakam.org04023556655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026