Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR

Launched by ZHONGTAO ZHANG · Jul 6, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to improve surgery for patients with mid- or low-rectal cancer. Specifically, researchers want to see if using a special imaging system called near infrared-indocyanine green (ICG) can help doctors measure blood flow to the area where the intestines are connected after surgery. By doing this, they hope to make surgeries safer and reduce the chances of complications, like leaks at the connection site, which can happen after the operation.

To be part of this study, participants need to be at least 18 years old and have a confirmed diagnosis of rectal cancer that hasn’t spread. They should be scheduled for a specific type of surgery called laparoscopic total mesorectal excision (TME). Certain health conditions, like allergies to ICG or serious illnesses, might prevent someone from joining. If someone is eligible, they will receive the usual care for their surgery along with the chance to benefit from this new imaging technology, helping researchers learn more about its usefulness for future patients.

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Eligibility criteria

• 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 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 Criteria:
• • 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.