Fluorescence Image Guided Foregut Surgery

NCT04734821 | Recruiting

• 1 other identifier: 20-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

Esophageal cancer; Gastric cancer; Lymphadenectomy; Complications; Anastomosis

Outcome Measures

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.

  During the surgical procedure

Secondary Outcomes (2)

• Evaluation of the impact of fluorescence guidance on the number of resected lymph nodes in oncological esogastric resections

  7 days after operation when pathologic result was reported

• Evaluation of the impact of fluorescence guidance in intraoperative evaluation of pre-anastomotic tissue perfusion

  30 days after operation

Study Arms (1)

NIR Fluorescence guided lymphadenectomy and anastomosis

EXPERIMENTAL

Procedure: Near Infra-Red Fluorescence Guided Surgery

Interventions

Near Infra-Red Fluorescence Guided Surgery PROCEDURE

ICG injection around tumor each four direction by endoscopy followed by NIR fluorescence guidance laparoscopic or robotic esophagectomy or gastrectomy

NIR Fluorescence guided lymphadenectomy and anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under the protection of justice.
• Patient under guardianship or trusteeship.
• Patient deprived of liberty

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne, NHC

Strasbourg, 67000, France

RECRUITING

Related Publications (21)

• Rosenthal 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 BACKGROUND

• van 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 BACKGROUND

• Tachimori 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 BACKGROUND

• Nafteux 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 BACKGROUND

• Songun 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 BACKGROUND

• Woo 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 BACKGROUND

• 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.

  PMID: 23881033 BACKGROUND

• Herrera-Almario G, Patane M, Sarkaria I, Strong VE. Initial report of near-infrared fluorescence imaging as an intraoperative adjunct for lymph node harvesting during robot-assisted laparoscopic gastrectomy. J Surg Oncol. 2016 Jun;113(7):768-70. doi: 10.1002/jso.24226. Epub 2016 Mar 29.

  PMID: 27021142 BACKGROUND

• Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.

  PMID: 30427990 BACKGROUND

• Kim TH, Kong SH, Park JH, Son YG, Huh YJ, Suh YS, Lee HJ, Yang HK. Assessment of the Completeness of Lymph Node Dissection Using Near-infrared Imaging with Indocyanine Green in Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2018 Jun;18(2):161-171. doi: 10.5230/jgc.2018.18.e19. Epub 2018 Jun 28.

  PMID: 29984066 BACKGROUND

• Turner SR, Molena DR. The Role of Intraoperative Fluorescence Imaging During Esophagectomy. Thorac Surg Clin. 2018 Nov;28(4):567-571. doi: 10.1016/j.thorsurg.2018.07.009.

  PMID: 30268302 BACKGROUND

• Hachey KJ, Gilmore DM, Armstrong KW, Harris SE, Hornick JL, Colson YL, Wee JO. Safety and feasibility of near-infrared image-guided lymphatic mapping of regional lymph nodes in esophageal cancer. J Thorac Cardiovasc Surg. 2016 Aug;152(2):546-54. doi: 10.1016/j.jtcvs.2016.04.025. Epub 2016 Apr 11.

  PMID: 27179838 BACKGROUND

• Park SY, Suh JW, Kim DJ, Park JC, Kim EH, Lee CY, Lee JG, Paik HC, Chung KY. Near-Infrared Lymphatic Mapping of the Recurrent Laryngeal Nerve Nodes in T1 Esophageal Cancer. Ann Thorac Surg. 2018 Jun;105(6):1613-1620. doi: 10.1016/j.athoracsur.2018.01.083. Epub 2018 Mar 5.

  PMID: 29518388 BACKGROUND

• Kaburagi T, Takeuchi H, Oyama T, Nakamura R, Takahashi T, Wada N, Saikawa Y, Kamiya S, Tanaka M, Wada T, Kitagawa Y. Intraoperative fluorescence lymphography using indocyanine green in a patient with chylothorax after esophagectomy: report of a case. Surg Today. 2013 Feb;43(2):206-10. doi: 10.1007/s00595-012-0391-6. Epub 2012 Oct 30.

  PMID: 23108512 BACKGROUND

• Kim M, Son SY, Cui LH, Shin HJ, Hur H, Han SU. Real-time Vessel Navigation Using Indocyanine Green Fluorescence during Robotic or Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Jun;17(2):145-153. doi: 10.5230/jgc.2017.17.e17. Epub 2017 Jun 9.

  PMID: 28680719 BACKGROUND

• Zehetner J, DeMeester SR, Alicuben ET, Oh DS, Lipham JC, Hagen JA, DeMeester TR. Intraoperative Assessment of Perfusion of the Gastric Graft and Correlation With Anastomotic Leaks After Esophagectomy. Ann Surg. 2015 Jul;262(1):74-8. doi: 10.1097/SLA.0000000000000811.

  PMID: 25029436 BACKGROUND

• Campbell C, Reames MK, Robinson M, Symanowski J, Salo JC. Conduit Vascular Evaluation is Associated with Reduction in Anastomotic Leak After Esophagectomy. J Gastrointest Surg. 2015 May;19(5):806-12. doi: 10.1007/s11605-015-2794-3. Epub 2015 Mar 20.

  PMID: 25791907 BACKGROUND

• Agzarian J, Visscher SL, Knight AW, Allen MS, Cassivi SD, Nichols FC 3rd, Shen KR, Wigle D, Blackmon SH. The cost burden of clinically significant esophageal anastomotic leaks-a steep price to pay. J Thorac Cardiovasc Surg. 2019 May;157(5):2086-2092. doi: 10.1016/j.jtcvs.2018.10.137. Epub 2018 Nov 15.

  PMID: 30558876 BACKGROUND

• Carrott PW, Markar SR, Kuppusamy MK, Traverso LW, Low DE. Accordion severity grading system: assessment of relationship between costs, length of hospital stay, and survival in patients with complications after esophagectomy for cancer. J Am Coll Surg. 2012 Sep;215(3):331-6. doi: 10.1016/j.jamcollsurg.2012.04.030. Epub 2012 Jun 8.

  PMID: 22683069 BACKGROUND

• Wang S, Xu L, Wang Q, Li J, Bai B, Li Z, Wu X, Yu P, Li X, Yin J. Postoperative complications and prognosis after radical gastrectomy for gastric cancer: a systematic review and meta-analysis of observational studies. World J Surg Oncol. 2019 Mar 18;17(1):52. doi: 10.1186/s12957-019-1593-9.

  PMID: 30885211 BACKGROUND

• Carus T, Dammer R. Laparoscop fluorescence angiography with indocyanine green to control the perfusion of gastrointestinal anastomoses intraoperatively. Surg Technol Int. 2012 Dec;22:27-32.

  PMID: 23315721 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Silvana PERRETTA, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armelle TAKEDA, PhD

CONTACT

+33 390413608; armelle.takeda@ihu-strasbourg.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 2, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)