Fluorescence Image Guided Foregut Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIHU Strasbourg
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Near Infra-Red Fluorescence Guided Surgery
Procedure/SurgeryICG injection around tumor each four direction by endoscopy followed by NIR fluorescence guidance laparoscopic or robotic esophagectomy or gastrectomy
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: NIR Fluorescence guided lymphadenectomy and anastomosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the usefulness of ICG fluorescence to guide lymphadenectomy in oncological esogastric resections
Additional detection (YES-NO) of lymph nodes after activation of the NIR fluorescence guidance system during lymphadenectomy.
Time frame
During the surgical procedureSecondary outcomes
1
Evaluation of the impact of fluorescence guidance on the number of resected lymph nodes in oncological esogastric resections
Number of lymph nodes, counted in anatomopathological analysis, obtained after fluorescence-guided lymphadenectomy in the esogastric oncology resections compared to historical data
Time frame
7 days after operation when pathologic result was reported2
Evaluation of the impact of fluorescence guidance in intraoperative evaluation of pre-anastomotic tissue perfusion
Anastomotic fistula rate after fluorescence control of pre-anastomotic vascularisation in oncological esogastric resections compared to historical data
Time frame
30 days after operationSponsors and contacts
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Source ClinicalTrials.gov