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

NCT06508541 | Completed DMC

• 1 other identifier: 2024-06-001
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

Indocyanine green; Colorectal cancer; prognosis

Outcome Measures

Primary Outcomes (1)

• disease-free survival(DFS)

  the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up

  1 month

Secondary Outcomes (1)

• the number of harvested lymph nodes

  1month

Study Arms (2)

conventional surgery

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

Procedure: conventional surgery

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

Procedure: ICG Guided surgery; Procedure: conventional surgery

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

Indocyanine green fluorescence-guided surgery

conventional surgery PROCEDURE

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

Indocyanine green fluorescence-guided surgery; conventional surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients with newly diagnosed CRC who underwent CRC surgery between December 2016 and August 2021 in Shanghai Tongren hospital

You may qualify if:

• 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-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (1)

Shanghai Tongren Hospital

Changning, Shanghai Municipality, 200336, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine surgical specimen

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 18, 2024
• Study Start: July 15, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CN (1)