The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer

NCT06583564 | Not Yet Recruiting

• 1 other identifier: 2024-038-01
• Study Type: interventional
• Target: 192
• 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 stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

Conditions

Colorectal Cancer Stage III

Keywords

Colorectal cancer; Indocyanine green; prognosis

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) rate

  the rate of of no recurrence or metastasis after 3 years from radical surgery

  From radical surgery to the end of follow-up ,up to 36 months

Secondary Outcomes (3)

• the number of harvested lymph nodes

  From radical surgery to the end of perioperative period at 1 month

• Postoperative complications

  From radical surgery to the end of perioperative period at 1 month

• Overall survival rate

  From radical surgery to the end of follow-up ,up to 36 months

Study Arms (2)

ICG group

EXPERIMENTAL

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 lymphangiography procedure

Non-ICG group

NO INTERVENTION

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

Interventions

ICG lymphangiography procedure PROCEDURE

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

ICG group

Eligibility Criteria

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

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, and
• 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
• severe mental disorder.

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (1)

Shanghai Tongren Hospital

Changning, Shanghai Municipality, 200336, China

Location

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: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 4, 2024
• Study Start: September 27, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

CN (1)