Indocyanine Green fluorescence imaging for accurate intraoperative detection of early gastric cancer
Phase 2
Recruiting
- Conditions
- Early gastric cancer
- Registration Number
- JPRN-jRCTs041180133
- Lead Sponsor
- Kodera Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. patients who are histologically proven gastric adenocarcinoma
2. patients who are diagnosed clinical T1 according to the 14th edition of Japanese Classification of Gastric Carcinoma
3. patients who receive informed consent
Exclusion Criteria
1. patients who have allergy to ICG
2. patients who have allergy to iodine
3. patients who are judged to be ineligible for subject by resercher
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Differences in length between preoperatively-determined and actual surgical margins
- Secondary Outcome Measures
Name Time Method Detection rate of ICG during gastrectomy, size of visualized ICG, morbidity of preoperative upper endoscopy, prevalence of adverse effects of ICG injection, operative time, intraoperative estimated blood loss, pathological findings (e.g. tumor depth, proximal and distal margin), postoperative morbidity rate, frequency of additional resection