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Trial Title:
Clinical Study of Radical Right Hemicolectomy Versus Radical Right Hemicolectomy Combined With Indocyanine Green Fluorescence Imaging Lymphatic Tracer Dissection for the Treatment of Right Colon Cancer
NCT ID:
NCT06485609
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
radical right hemicolectomy combined with indocyanine green fluorescence imaging lymphatic tracer dissection
Description:
radical right hemicolectomy combined with indocyanine green fluorescence imaging
lymphatic tracer dissection
Arm group label:
radical right hemicolectomy combined with indocyanine green fluorescence imaging lymphatic tracer di
Summary:
The purpose of this study is to explore the clinical outcomes of indocyanine green
fluorescence using in laparoscopic radical right hemicolectomy for right colon
cancer（T1-T4a N+ M0）
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age between 18 and 75 years old 2. Confirmed adenocarcinoma cancer
pathologically 3. Location of tumor: from the cecum to the right third of the
transverse colon 4. CT showed right colon cancer: T1-T4a N+ M0 5. ASA scores
I-III 6. ECOG (Eastern Cooperative Oncology Group) scale performance status of
0 or 1 7. Patient or family member, able to understand the study protocol and
willing to participate in the study, providing written informed consent
Exclusion Criteria:
-
1. Simultaneous or heterochronic multiple primary colon cancer 2. Patients with
intestinal obstruction, intestinal perforation, intestinal bleeding, etc.
requiring emergency surgery 3. Unsuitable for laparoscopic surgery (e.g.,
extensive adhesions due to previous major abdominal surgery; unsuitable for
pneumoperitoneum for various reasons, etc.) 4. Pregnant or lactating women 5.
Have a history of serious mental illness 6. History of iodine allergy 7.
History of other malignant diseases within the last five years 8. History of
prior neoadjuvant chemotherapy or radiation therapy 9. History of unstable
angina or myocardial infarction within the last 6 months 10. History of
continuous systemic corticosteroid use within one month
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sixth Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
hao Xie, doctor
Email:
xieh37@mail2.sysu.edu.cn
Start date:
August 10, 2024
Completion date:
July 1, 2031
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06485609
