Clinical trial · Interventional
ICG in Colon Cancer
A Prospective Study of Indocyanine Green (ICG) Fluorescence-Guided Lymphatic Mapping During Laparoscopic Colon Cancer Resection
- 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)
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.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| ICG (Indocyanine Green) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green (ICG) injection for intraoperative lymph node imaging | Drug | — | UNRESOLVED |
| Laparoscopic Colon Cancer Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG-Guided Surgery
- description
- All patients enrolled in this single-arm study will undergo intraoperative subserosal injection of Indocyanine Green (ICG) for fluorescence-guided lymphatic mapping prior to mesenteric dissection. Additionally, an intravenous ICG injection will be administered to assess bowel perfusion before creating the anastomosis during laparoscopic colon cancer resection.
- interventionNames
- Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging
- Procedure: Laparoscopic Colon Cancer Resection
Primary outcomes (1)
- measure
- Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin
- timeFrame
- Up to 2 weeks postoperatively (upon completion of final histopathology report)
- description
- This outcome evaluates the accuracy of ICG mapping. It is measured as the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Age \>= 18 years. \- Histologically confirmed colon adenocarcinoma. Exclusion Criteria: * Emergency surgery (obstruction/perforation with sepsis) requiring urgent operation. * Known allergy or contraindication to ICG (including prior anaphylaxis to ICG; severe hypersensitivity history per anesthesia assessment). * Pregnancy or breastfeeding. * Severe hepatic failure (because ICG clearance is hepatobiliary) or other contraindication determined by anesthesia team. * Planned palliative resection only. * ASA physical status IV or patients otherwise deemed unfit for elective curative colectomy.
References
Publications (3)
- BACKGROUNDGalema 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. PMID 34657780
- BACKGROUNDWexner 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. PMID 36427929
- BACKGROUNDCassinotti 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. PMID 36781468