ICG in Colon Cancer

Summary

The aim of this study is to evaluate the role of indocyanine green (ICG) injection in fluorescence-guided lymphatic mapping during laparoscopic colon cancer resection. This is a single-center prospective single-arm pilot clinical study that will include at least 25 patients with resectable colon cancer. All enrolled patients will undergo intraoperative subserosal ICG-guided lymphatic mapping before dissection, and intravenous ICG perfusion assessment before anastomosis. The primary goal is to determine the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.

Timeline

Start

2026-06-01

Primary completion

2027-09-01

Completion

2028-11-01

Publications

• Background Galema HA, Meijer RPJ, Lauwerends LJ, Verhoef C, Burggraaf J, Vahrmeijer AL, Hutteman M, Keereweer S, Hilling DE. Fluorescence-guided surgery in colorectal cancer; A review on clinical results and future perspectives. Eur J Surg Oncol. 2022 Apr;48(4):810-821. doi: 10.1016/j.ejso.2021.10.005. Epub 2021 Oct 9.
• Background Wexner S, Abu-Gazala M, Boni L, Buxey K, Cahill R, Carus T, Chadi S, Chand M, Cunningham C, Emile SH, Fingerhut A, Foo CC, Hompes R, Ioannidis A, Keller DS, Knol J, Lacy A, de Lacy FB, Liberale G, Martz J, Mizrahi I, Montroni I, Mortensen N, Rafferty JF, Rickles AS, Ris F, Safar B, Sherwinter D, Sileri P, Stamos M, Starker P, Van den Bos J, Watanabe J, Wolf JH, Yellinek S, Zmora O, White KP, Dip F, Rosenthal RJ. Use of fluorescence imaging and indocyanine green during colorectal surgery: Results of an intercontinental Delphi survey. Surgery. 2022 Dec;172(6S):S38-S45. doi: 10.1016/j.surg.2022.04.016.
• Background Cassinotti E, Al-Taher M, Antoniou SA, Arezzo A, Baldari L, Boni L, Bonino MA, Bouvy ND, Brodie R, Carus T, Chand M, Diana M, Eussen MMM, Francis N, Guida A, Gontero P, Haney CM, Jansen M, Mintz Y, Morales-Conde S, Muller-Stich BP, Nakajima K, Nickel F, Oderda M, Parise P, Rosati R, Schijven MP, Silecchia G, Soares AS, Urakawa S, Vettoretto N. European Association for Endoscopic Surgery (EAES) consensus on Indocyanine Green (ICG) fluorescence-guided surgery. Surg Endosc. 2023 Mar;37(3):1629-1648. doi: 10.1007/s00464-023-09928-5. Epub 2023 Feb 13.

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Indications