Near Infra-Red Fluorescence Guided Surgery: ICG injection around tumor each four direction by endoscopy followed by NIR fluorescence guidance laparoscopic or robotic esophagectomy or gastrectomy
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Evaluation of the usefulness of ICG fluorescence to guide lymphadenectomy in oncological esogastric resections — During the surgical procedure Additional detection (YES-NO) of lymph nodes after activation of the NIR fluorescence guidance system during lymphadenectomy.
Trial sites (1)
Facility
City
Region
Status
Service de Chirurgie Digestive et Endocrinienne, NHC
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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