A clinical trial to study the safety and effectiveness of Indocyanine green guided lymph node dissection during gastric cancer surgery.
- Conditions
- Health Condition 1: C169- Malignant neoplasm of stomach, unspecified
- Registration Number
- CTRI/2023/10/058820
- Lead Sponsor
- Dr Siba Narayan Padhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of retrieved lymph nodesTimepoint: At Discharge
- Secondary Outcome Measures
Name Time Method 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