Clinical trial · Interventional
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
NCT04734821CI-TRIAL-00089156FOREGUTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Near Infra-Red Fluorescence Guided Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NIR Fluorescence guided lymphadenectomy and anastomosis
- interventionNames
- Procedure: Near Infra-Red Fluorescence Guided Surgery
Primary outcomes (1)
- measure
- Evaluation of the usefulness of ICG fluorescence to guide lymphadenectomy in oncological esogastric resections
- timeFrame
- During the surgical procedure
- description
- Additional detection (YES-NO) of lymph nodes after activation of the NIR fluorescence guidance system during lymphadenectomy.
Secondary outcomes (2)
- measure
- Evaluation of the impact of fluorescence guidance on the number of resected lymph nodes in oncological esogastric resections
- timeFrame
- 7 days after operation when pathologic result was reported
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (21)
- BACKGROUNDRosenthal EL, Warram JM, Bland KI, Zinn KR. The status of contemporary image-guided modalities in oncologic surgery. Ann Surg. 2015 Jan;261(1):46-55. doi: 10.1097/SLA.0000000000000622. PMID 25599326
- BACKGROUNDvan der Werf LR, Dikken JL, van Berge Henegouwen MI, Lemmens VEPP, Nieuwenhuijzen GAP, Wijnhoven BPL; Dutch Upper GI Cancer Audit group. A Population-based Study on Lymph Node Retrieval in Patients with Esophageal Cancer: Results from the Dutch Upper Gastrointestinal Cancer Audit. Ann Surg Oncol. 2018 May;25(5):1211-1220. doi: 10.1245/s10434-018-6396-7. Epub 2018 Mar 9. PMID 29524046
- BACKGROUNDTachimori Y. Pattern of lymph node metastases of squamous cell esophageal cancer based on the anatomical lymphatic drainage system: efficacy of lymph node dissection according to tumor location. J Thorac Dis. 2017 Jul;9(Suppl 8):S724-S730. doi: 10.21037/jtd.2017.06.19. PMID 28815068
- BACKGROUNDNafteux P, Depypere L, Van Veer H, Coosemans W, Lerut T. Principles of esophageal cancer surgery, including surgical approaches and optimal node dissection (2- vs. 3-field). Ann Cardiothorac Surg. 2017 Mar;6(2):152-158. doi: 10.21037/acs.2017.03.04. PMID 28447004
- BACKGROUNDSongun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19. PMID 20409751
- BACKGROUNDWoo Y, Goldner B, Ituarte P, Lee B, Melstrom L, Son T, Noh SH, Fong Y, Hyung WJ. Lymphadenectomy with Optimum of 29 Lymph Nodes Retrieved Associated with Improved Survival in Advanced Gastric Cancer: A 25,000-Patient International Database Study. J Am Coll Surg. 2017 Apr;224(4):546-555. doi: 10.1016/j.jamcollsurg.2016.12.015. Epub 2016 Dec 23. PMID 28017807
- Vahrmeijer AL, Hutteman M, van der Vorst JR, van de Velde CJ, Frangioni JV. Image-guided cancer surgery using near-infrared fluorescence. Nat Rev Clin Oncol. 2013 Sep;10(9):507-18. doi: 10.1038/nrclinonc.2013.123. Epub 2013 Jul 23.