Clinical trial NCT04012645: Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
Official title: A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Rectal Neoplasms
Indocyanine Green
Anastomotic Leakage
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Beijing Chao Yang Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Chinese PLA General Hospital
name: Peking University People's Hospital
name: Peking University Cancer Hospital & Institute
name: Beijing Hospital
name: Changhai Hospital
name: Ruijin Hospital
name: RenJi Hospital
name: Fudan University
name: Guangdong Provincial People's Hospital
name: Southern Medical University, China
name: First Hospital of China Medical University
name: The First Hospital of Jilin University
name: The First Affiliated Hospital with Nanjing Medical University
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2019-07-09
Enrollment: 547
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

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 anastomotic leakage, and once anastomotic leakage occurs, the perioperative mortality rate of patients is reportedly 16%. In the past, the assessment of anastomotic blood supply mainly depended on the experience of the surgeon and lacked objective and accurate assessment methods. In recent years, the application of near-infrared fluorescence laparoscopic imaging technology has provided a new way to accurately evaluate anastomotic perfusion. At present, the technology has been applied to evaluate anastomotic blood supply in colorectal cancer surgery worldwide, and its safety and reliability have been confirmed. However, whether the application of this technology can reduce the incidence of anastomotic leakage after total mesorectal excision for rectal cancer and thus benefit patients still needs high-level evidence-based medical evidence support with multi-centers and large samples.Thus, a multicenter, prospective, and randomized controlled clinical study of patients with mid- or low- rectal cancer who received laparoscopic TME surgery was intend to conduct to explore whether the application of near infrared-indocyanine green imaging system can evaluate the anastomotic blood perfusion accurately, and optimize the surgical procedures, or even reduce the incidence rates of postoperative anastomotic leakage in mid- or low- rectal cancer patients.

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.

Primary outcomes:
measure: Anastomotic leakage
timeFrame: within 30 days after operation
Secondary outcomes:
measure: the change of surgical precedure
timeFrame: within the operation time
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital medical University
state: Xicheng Dis
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: