Status:
UNKNOWN
Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
Lead Sponsor:
Zhongtao Zhang
Collaborating Sponsors:
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
It is a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery aims to explore whether the application of ...
Detailed Description
In total mesorectal excision of rectal cancer, accurate assessment of rectal anastomotic blood supply is crucial: for insufficient anastomotic blood supply is an important cause of postoperative anast...
Eligibility Criteria
Inclusion
- 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 tumor and 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
- Allergic to ICG or iodine;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding who need 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 the past four weeks;
- Patients that ASA level is larger than III;
- Physical condition: Patients with KPS less than or equal to 60 points or ECOG larger than 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 the researchers.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT04012645
Start Date
November 16 2023
End Date
December 1 2023
Last Update
November 18 2023
Active Locations (2)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
2
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, China, 100050