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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-04-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Silvana PERRETTA, MD, PhD
PRINCIPAL INVESTIGATOR
Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
Frequently Asked Questions
Who can join the NCT04734821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04734821 currently recruiting?
Yes, NCT04734821 is actively recruiting participants. Contact the research team at armelle.takeda@ihu-strasbourg.eu for enrollment information.
Where is the NCT04734821 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT04734821 clinical trial?
NCT04734821 is sponsored by IHU Strasbourg. The principal investigator is Silvana PERRETTA, MD, PhD at Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg. The trial plans to enroll 60 participants.
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