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ICG in Colon Cancer

ConditionsColon CancerICG (Indocyanine Green)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: ICG-Guided SurgeryExperimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Successful intraoperative visualization of lymphatic drainage (Feasibility rate)

The rate of successful intraoperative visualization of lymphatic channels and nodal basins after subserosal ICG injection.

Time frame
Intraoperative
2

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.

Time frame
Intraoperative
3

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.

Time frame
Intraoperative
4

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: