ICG in Colon Cancer

Sponsor
Tanta University
Study ID
NCT07638956
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Laparoscopic Colon Cancer Resection — PROCEDURE
    Standard laparoscopic colectomy with oncologic lymphadenectomy performed according to institutional practice.

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Proportion of analyzable pN+ patients with all metastatic lymph nodes located within the ICG-mapped lymphatic basin [ Time Frame: Up to 2 weeks postoperatively (upon completion of final histopathology report) ]

Central Contacts

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