RecruitingNot ApplicableNCT04734821

Fluorescence Image Guided Foregut Surgery

Prospective Study on the Contribution of Fluorescence in the Guidance of Lymphadenectomy and in Peroperative Evaluation of Pre-anastomotic Tissue Perfusion in Laparoscopic Esogastric Oncologic Resections


Sponsor

IHU Strasbourg

Enrollment

60 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

Interventions

PROCEDURENear 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


Locations(1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, France

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NCT04734821


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