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

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ClinicalTrials.gov Identifier: NCT04012645
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese PLA General Hospital
Peking University People's Hospital
Beijing Cancer Hospital
Beijing Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
RenJi Hospital
Fudan University
Guangdong Provincial People's Hospital
Southern Medical University, China
First Hospital of China Medical University
First Hospital of Jilin University
The First Affiliated Hospital with Nanjing Medical University
Fujian Medical University Union Hospital
First Affiliated Hospital of Chongqing Medical University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Zhongtao Zhang, Beijing Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Procedure: application of near infrared-indocyanine green imaging system Procedure: Non-application of near infrared-indocyanine green imaging system Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 547 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.
Procedure: application of near infrared-indocyanine green imaging system
Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used to evaluate the anastomotic flood perfusion during the operation; The operator may decide whether to change the surgical programme based on the outcome of the evaluation.

Active Comparator: control group
Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience
Procedure: Non-application of near infrared-indocyanine green imaging system
Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience




Primary Outcome Measures :
  1. Anastomotic leakage [ Time Frame: within 30 days after operation ]
    Anastomotic leakage occured within 30 days after operation. The diagnostic criteria for AL include: Flow of gas, abscess, or excrement from pelvic drainage tube, surgical incision or vagina; Accompanied by fever, peritonitis and other systemic symptoms; And AL confirmed by digestive tract radiography, CT scan or enteroscopy.


Secondary Outcome Measures :
  1. the change of surgical precedure [ Time Frame: within the operation time ]
    the change of intraoperative decision, including: (1) The change of the position of intestinal dissection; (2) Anastomotic stoma was removed and rebuilt or re-performed hartmann operation; (3) The performance of unplanned, preventive orifice, etc. due to ICG test results.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012645


Contacts
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Contact: Zhongtao Zhang, Professor 13801060364 zhangzht@medmail.com.cn
Contact: Hongwei Yao, Professor 13611015609 yaohongwei@medmail.com.cn

Locations
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China, Beijing
Beijing Friendship Hospital
Beijing, Beijing, China, 100050
China, Xicheng Dis
Beijing Friendship Hospital, Capital medical University
Beijing, Xicheng Dis, China, 100050
Sponsors and Collaborators
Zhongtao Zhang
Peking Union Medical College Hospital
Beijing Chao Yang Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese PLA General Hospital
Peking University People's Hospital
Beijing Cancer Hospital
Beijing Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
RenJi Hospital
Fudan University
Guangdong Provincial People's Hospital
Southern Medical University, China
First Hospital of China Medical University
First Hospital of Jilin University
The First Affiliated Hospital with Nanjing Medical University
Fujian Medical University Union Hospital
First Affiliated Hospital of Chongqing Medical University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Zhongtao Zhang, Professor Beijing Friendship Hospital
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Responsible Party: Zhongtao Zhang, Director of General Surgery of Beijing Friendship Hospital, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT04012645    
Other Study ID Numbers: Poster
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongtao Zhang, Beijing Friendship Hospital:
Rectal Neoplasms
Indocyanine Green
Anastomotic Leakage
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases