Using fluorescence imaging to improve surgery for esophageal and gastric cancer
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
This study is testing if a special imaging technique can help surgeons remove more lymph nodes and make better connections in the stomach and esophagus during cancer surgery to improve recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHU Strasbourg Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04734821 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of Indocyanine Green (ICG) and near infra-red (NIR) fluorescence imaging to enhance the surgical outcomes for patients undergoing esophagectomy or gastrectomy due to cancer. The focus is on increasing the number of lymph nodes resected and improving the quality of gastrointestinal tract anastomoses, which are critical for patient survival and recovery. By employing advanced imaging techniques, the study aims to provide surgeons with better guidance during operations, potentially leading to improved prognostic outcomes for patients. The study will include patients with resectable esophageal or gastric cancer who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with resectable esophageal or gastric cancer confirmed by biopsy, without distant metastases.
Not a fit: Patients with distant metastasis, those undergoing emergency surgery, or individuals with allergies to indocyanine green will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and better surgical outcomes for patients with esophageal and gastric cancer.
How similar studies have performed: While the use of fluorescence imaging in surgery is gaining traction, this specific application in esophageal and gastric cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Strasbourg
- Service de Chirurgie Digestive et Endocrinienne, NHC — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Silvana PERRETTA, MD, PhD — Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
- Study coordinator: Armelle TAKEDA, PhD
- Email: armelle.takeda@ihu-strasbourg.eu
- Phone: +33 390413608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.