---
title: The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery
nct_id: NCT06508541
overall_status: COMPLETED
sponsor: Shanghai Tong Ren Hospital
study_type: OBSERVATIONAL
primary_condition: Colorectal Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06508541.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06508541"
ct_last_update_post_date: 2024-12-16
last_seen_at: "2026-05-12T07:06:42.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery

**Official Title:** The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery: a Retrospective Cohort Study

**NCT ID:** [NCT06508541](https://clinicaltrials.gov/study/NCT06508541)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 235
- **Lead Sponsor:** Shanghai Tong Ren Hospital
- **Conditions:** Colorectal Cancer
- **Start Date:** 2024-07-15
- **Completion Date:** 2024-10-01
- **CT.gov Last Update:** 2024-12-16

## Brief Summary

Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* age \&amp;gt; 18 years,
* confirmed diagnosis of primary CRC,
* preoperative tumor stage of cT1 to cT4, N-/+, M0 as determined by contrast-enhanced computed tomography (CT),
* no distant metastasis, -American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3-

Exclusion Criteria:

* history of previous colorectal surgery, emergent surgery, or palliative resection;
* pregnancy or breastfeeding;
* allergy or history of an adverse reaction to ICG; and
* severe mental disorder.
```

## Arms

- **conventional surgery** — All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.
- **Indocyanine green fluorescence-guided surgery** — Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure

## Interventions

- **ICG Guided surgery** (PROCEDURE) — In ICG guided surgery group,Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure
- **conventional surgery** (PROCEDURE) — All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose

## Primary Outcomes

- **disease-free survival(DFS)** _(time frame: 1 month)_ — the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up

## Secondary Outcomes

- **the number of harvested lymph nodes** _(time frame: 1month)_

## Locations (1)

- Shanghai Tongren Hospital, Changning, Shanghai Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shanghai tongren hospital|changning|shanghai municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06508541*  
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