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

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

Study Description
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.
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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.
Contacts and Locations

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
The 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
Layout table for investigator information
Principal Investigator: Zhongtao Zhang, Professor Beijing Friendship Hospital
Tracking Information
First Submitted Date  ICMJE July 6, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 11, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2019) 		Anastomotic leakage [ Time Frame: within 30 days after operation ]
Anastomotic leakage occured within 30 days after operation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
Official Title  ICMJE A Study Assessing Perfusion Outcomes With Near Infrared-Indocyanine Green Imaging System in Laparoscopic Total Mesorectal Excision for Mid- or Low-rectal CanceR
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Rectal Neoplasms
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: experimental group
    Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used during the surgeries.
    Intervention: Procedure: application of near infrared-indocyanine green imaging system
  • 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
    Intervention: Procedure: Non-application of near infrared-indocyanine green imaging system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2019) 		547
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zhongtao Zhang, Professor 13801060364 zhangzht@medmail.com.cn
Contact: Hongwei Yao, Professor 13611015609 yaohongwei@medmail.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012645
Other Study ID Numbers  ICMJE Poster
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhongtao Zhang, Beijing Friendship Hospital
Study Sponsor  ICMJE Zhongtao Zhang
Collaborators  ICMJE
  • 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
  • The 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  ICMJE
Principal Investigator: Zhongtao Zhang, Professor Beijing Friendship Hospital
PRS Account Beijing Friendship Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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