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The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery

NCT ID: NCT06508541

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2024-10-01

Brief Summary

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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

Detailed Description

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Conditions

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Colorectal Cancer

Keywords

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Indocyanine green Colorectal cancer prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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conventional surgery

All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.

conventional surgery

Intervention Type PROCEDURE

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

ICG Guided surgery

Intervention Type 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

Intervention Type PROCEDURE

All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose

Interventions

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ICG Guided surgery

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

Intervention Type PROCEDURE

conventional surgery

All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age \> 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Tong Ren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Tongren Hospital

Changning, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2024-06-001

Identifier Type: -

Identifier Source: org_study_id