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A clinical trial to study the safety and effectiveness of Indocyanine green guided lymph node dissection during gastric cancer surgery.

Feasibility and Efficacy of Indocyanine Green Navigated Lymphadenectomy in Patients Undergoing Gastric Cancer Surgery: A Randomised Controlled Trial in a Tertiary Care Centre in India - FINGERS Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058820
Enrollment
48
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: C169- Malignant neoplasm of stomach, unspecified

Interventions

Intervention1: Subtotal/Total Gastrectomy with standard D2 lymphadenectomy along with the use of near-infrared imaging (Indocyanine Green(ICG) Group): For patients who were assigned to the ICG group,

Sponsors

Dr Siba Narayan Padhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy 2.Clinical stage tumour T1-4b (cT1-4b), irrespective of Nodal status, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition 3.Patients with a performance status of Eastern Cooperative Oncology Group (ECOG)-0 ,1, and 2.

Exclusion criteria

Exclusion criteria: 1.Gastro-Esophageal junction tumors 2.Linitis plastica 3.History of previous neoadjuvant chemotherapy or radiotherapy 4.History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 5.History of previous gastric surgery 6.Patient desiring for Laparoscopic Gastrectomy or not giving consent for Open surgery 7.Not giving consent for ICG injection 8.History of allergy to iodine agents 9.Women during pregnancy or breast-feeding

Design outcomes

Primary

MeasureTime frame
Number of retrieved lymph nodesTimepoint: At Discharge

Secondary

MeasureTime frame
False Negative RateTimepoint: At Discharge;False Positive RateTimepoint: At Discharge;Intra-operative Blood LossTimepoint: On Day of Surgery;Metastatic Rate of Lymph NodesTimepoint: At Discharge;Morbidity and Mortality RatesTimepoint: At Discharge;Negative RateTimepoint: At Discharge;Non-compliance in lymph node dissectionTimepoint: At Discharge;Number of Metastatic Lymph NodesTimepoint: At Discharge;Operative TimeTimepoint: On Day of Surgery;Positive RateTimepoint: At Discharge;Rate of FluorescenceTimepoint: At Discharge

Countries

India

Contacts

Public ContactDr Tanmay Dutta

AIIMS, BHUBANESWAR

dr.tanmaydutta@gmail.com8009103940

Outcome results

None listed

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