NCT04734821Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Jan 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- IHU Strasbourg
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04734821
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Apr 2021 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient in exclusion period (determined by a previous or a current study).
Other illness
- Patient undergoing emergency surgery (hemorrhage, occlusion or perforation).
- Patient at risk of allergy to indocyanine green or to other fluorescent compounds
Other
- Presence of distant metastasis
- Pregnant or lactating patient.
- Patient under the protection of justice.
- Patient under guardianship or trusteeship.
- Patient deprived of liberty
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne, NHC Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.