ICG in Colon Cancer

NCT07638956 | Not Yet Recruiting

• 1 other identifier: 36265MD41060/4/26
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colon Cancer; ICG (Indocyanine Green)

Outcome Measures

Primary Outcomes (1)

• Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin

  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.

  Up to 2 weeks postoperatively (upon completion of final histopathology report)

Secondary Outcomes (6)

• Successful intraoperative visualization of lymphatic drainage (Feasibility rate)

  Intraoperative

• Frequency of fluorescence-guided modification of mesenteric excision

  Intraoperative

• Change in the planned transection line due to perfusion assessment

  Intraoperative

• Metastatic lymph nodes identified outside conventional resection margins

  Up to 2 weeks postoperatively (upon completion of final histopathology report)

• Total Lymph nodal yield

  Up to 2 weeks postoperatively (upon completion of final histopathology report)

Study Arms (1)

ICG-Guided Surgery

EXPERIMENTAL

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.

Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging; Procedure: Laparoscopic Colon Cancer Resection

Interventions

Indocyanine green (ICG) injection for intraoperative lymph node imaging DRUG

Indocyanine green is injected subserosally around the tumor in four quadrants for lymphatic mapping. Additionally, intravenous ICG is administered before bowel anastomosis to assess perfusion of the bowel ends using near-infrared fluorescence imaging.

ICG-Guided Surgery

Laparoscopic Colon Cancer Resection PROCEDURE

Standard laparoscopic colectomy with oncologic lymphadenectomy performed according to institutional practice.

ICG-Guided Surgery

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years.
• \- Histologically confirmed colon adenocarcinoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (3)

• 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.

  PMID: 34657780 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.

  PMID: 36427929 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.

  PMID: 36781468 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Indocyanine Green; Injections

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Kirollos S Fathy Messiha, Asiistant Lecturer

CONTACT

+201012049716; Kerles.samir@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ِAssistant lecturer

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available beginning 6 months and ending 36 months following the publication of the main study results.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal to achieve specific scientific aims. Access will be strictly limited to de-identified individual participant data. Proposals should be directed to the principal investigator via email. Requestors may be required to sign a data access agreement to ensure data privacy and ethical compliance.