Last updated: July 18, 2023
Sponsor: Zhongtao Zhang
Overall Status: Active - Recruiting
Phase
N/A
Condition
Colon Cancer
Digestive System Neoplasms
Rectal Cancer
Treatment
application of near infrared-indocyanine green imaging system
Non-application of near infrared-indocyanine green imaging system
Clinical Study ID
NCT04012645
Poster
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The age was over 18 years at the time of diagnosis;
- Diagnosis of rectal carcinoma and was confirmed by preoperative pathology;
- MRI was performed before operation, and the distance between the lower margin of tumorand the anal margin was no more than 10cm;
- The colon-rectum or colon-anus anastomosis was performed by laparoscopic TME operation
- The "spleen area" was not free during the operation
- Baseline clinical tumor stage TNM Ⅰ-Ⅲ phase: cT1-4N0-2M0 (AJCC-8 version);
Exclusion
Exclusion Criteria:
- Allergic to ICG or iodine;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding whoneed emergency operation;
- Patients requiring combined organ resection that the tumor involves adjacent organs;
- Patients with recurrence of tumor or distant metastasis;
- Patients with multiple colorectal cancer;
- Patients with history of inflammatory bowel disease or familial adenomatous polyposis;
- Patients who have participated in or are participating in other clinical trials in thepast four weeks;
- Patients that ASA level is larger than III;
- Physical condition: Patients with KPS less than or equal to 60 points or ECOG largerthan or equal to 2 points;
- Patients with hepatic dysfunction and MELD larger than 12 points;
- Patients with a history of serious mental illness;
- Pregnant or lactating women;
- Patients who are improper to participate in the study in the opinion of theresearchers.
Study Design
Total Participants: 547
Treatment Group(s): 2
Primary Treatment: application of near infrared-indocyanine green imaging system
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
December 01, 2023
Study Description
Connect with a study center
Beijing Friendship Hospital
Beijing, Beijing 100050
ChinaActive - Recruiting
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis 100050
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.