NCT04734821 Fluorescence Image Guided Foregut Surgery
| NCT ID | NCT04734821 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IHU Strasbourg |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-03-31 |
Trial Parameters
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Brief Summary
A high number of resected lymph nodes is an independent prognostic factor for improved survival after esophagectomy or gastrectomy for cancer. The quality of the lymphadenectomy is operator-dependent, as is the evaluation of the vascularization of the digestive structures that are anastomosed to restore digestive continuity after esophago-gastric resection. The aim of the study is to evaluate the impact of Indocyanine Green (ICG) and near infra-red (NIR) fluorescence imaging guidance in terms of number of lymph nodes resected and quality of gastrointestinal tract anastomoses in esophagogastric cancer surgery.
Eligibility Criteria
Inclusion Criteria: * Man or woman over 18 years old. * Patient with resectable primitive esophageal or gastric cancer confirmed by biopsy without distant metastases * Patient with no contraindications to anaesthesia and performance of esophageal and/or gastric surgery * Patient able to receive and understand information related to the study and give written informed consent. * Patient affiliated to the French social security system. Exclusion Criteria: * Patient undergoing emergency surgery (hemorrhage, occlusion or perforation). * Presence of distant metastasis * Patient at risk of allergy to indocyanine green or to other fluorescent compounds * Pregnant or lactating patient. * Patient in exclusion period (determined by a previous or a current study). * Patient under the protection of justice. * Patient under guardianship or trusteeship. * Patient deprived of liberty
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