ICG in Colon Cancer (ICG)

A Prospective Study of Indocyanine Green (ICG) Fluorescence-Guided Lymphatic Mapping During Laparoscopic Colon Cancer Resection

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Cancer; ICG (Indocyanine Green)
• Intervention / Treatment: Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging; Procedure: Laparoscopic Colon Cancer Resection

Detailed Description

Adequate lymphadenectomy is a key component of curative colon cancer surgery because lymph node status is essential for accurate staging and postoperative treatment planning. Indocyanine green (ICG) fluorescence imaging has become increasingly used intraoperatively to make otherwise invisible lymphatic pathways visible in real time.

Preoperative and Perioperative Care:

All patients will undergo standard preoperative evaluation including colonoscopy with biopsy confirmation, baseline laboratory investigations, carcinoembryonic antigen measurement, and contrast-enhanced CT staging. Perioperative care will follow an enhanced recovery pathway including counseling, thromboembolism prophylaxis, antibiotic prophylaxis, multimodal analgesia, early mobilization, and early oral intake.

Operative Protocol:

Laparoscopic oncologic colectomy will be performed according to tumor location. Fluorescence imaging will be performed using the KARL STORZ IMAGE1 STM Rubina platform. Indocyanine green will be injected subserosally around the tumor in four quadrants whenever feasible. Near-infrared imaging will then be used to identify lymphatic channels and nodal basins before definitive mesenteric division. Any fluorescence-related modification of the extent of mesenteric excision or pedicle clearance will be recorded prospectively. Before bowel anastomosis, intravenous indocyanine green will be used to assess perfusion of the bowel ends by near-infrared fluorescence imaging.

Pathology and Follow-up:

The mapped area will be identified on the specimen by sutures or clips or separately labeled packets, allowing the pathologist to record metastatic lymph nodes as located within or outside the ICG-mapped basin. Patients will be followed during hospital admission and for 3, 6, and 9 months after surgery to record postoperative complications, final histopathological outcomes, and morbidity according to the Clavien-Dindo classification

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirollos S Fathy Messiha, Asiistant Lecturer; Phone Number: +201012049716; Email: Kerles.samir@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ICG-Guided Surgery; 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; 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.; Procedure: Laparoscopic Colon Cancer Resection; Standard laparoscopic colectomy with oncologic lymphadenectomy performed according to institutional practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful intraoperative visualization of lymphatic drainage (Feasibility rate)	The rate of successful intraoperative visualization of lymphatic channels and nodal basins after subserosal ICG injection.	Intraoperative
Frequency of fluorescence-guided modification of mesenteric excision	The frequency at which ICG mapping prompts a modification in the extent of mesenteric excision or pedicle clearance.	Intraoperative
Change in the planned transection line due to perfusion assessment	The proportion of cases in which intravenous ICG perfusion assessment leads to a change in the planned bowel transection line.	Intraoperative
Metastatic lymph nodes identified outside conventional resection margins	The frequency of identifying metastatic lymph nodes located outside the predefined conventional resection margins using ICG guidance.	Up to 2 weeks postoperatively (upon completion of final histopathology report)
Total Lymph nodal yield	The total number of lymph nodes retrieved per patient as determined by final histopathological assessment.	Up to 2 weeks postoperatively (upon completion of final histopathology report)
Postoperative Morbidity and Mortality	The incidence of postoperative complications (graded according to the Clavien-Dindo classification), readmission, reoperation, and mortality rates.	Baseline, postoperative day 30, and at 3, 6, and 9 months after surgery

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Indoles; Injections; Indocyanine Green
• Other Study ID Numbers: 36265MD41060/4/26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results reported in this study will be shared upon reasonable request to the principal investigator. In accordance with the study's ethical approval, confidentiality will be strictly maintained using coded data.
• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 36 months following the publication of the main study results.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No