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Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT04207489
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dong Yang, Jilin University

Brief Summary:
Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer

Condition or disease Intervention/treatment
Colorectal Cancer Indocyanine Green Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer

Detailed Description:

To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer, and analyze the relevant factors, so as to guide the submucosal injection of preoperative indocyanine green better.

This study is prospective and observational. In order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical resection for colorectal cancer.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Prospective Registry Study of Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer
Estimated Study Start Date : December 25, 2019
Estimated Primary Completion Date : December 25, 2020
Estimated Study Completion Date : April 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
endoscopic submucosal injection of indocyanine green Procedure: endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer
Indocyanine green was injected under endoscope within 24 hours before operation. Four points were evenlyinjected in four quadrants at the edge of the tumor. The patients with obstruction were injected at two points on the anal side of the tumor. The diluted concentration of indocyanine green was 0.625mg/ml or 1.25mg/ml. The injection method was direct submucosal injection and sandwich method. According to the imaging effect, it can be divided into local imaging and lymphatic drainage imaging. Tumor body: 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation. Lymph drainage area imaging 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation.




Primary Outcome Measures :
  1. The imaging effect of indocyanine green [ Time Frame: During the operation ]
    The imaging effect was evaluated by indocyanine green fluorescence imaging system during the operation. According to the imaging effect, it can be divided into local imaging and lymphatic drainage imaging. Tumor body: 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation. Lymph drainage area imaging 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation.



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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
Sampling Method:   Probability Sample
Study Population
Patients who were to undergo indocyanine green fluorescence imaging for laparoscopicradical operation of colorectal cancer.
Criteria

Inclusion Criteria:

  • Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.

Exclusion Criteria:

  • have simultaneously other cancer

    • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
    • have gastrointestinal surgery
    • Indocyanine green or iodine allergy
    • the period is too late or the tumor is too large to carry on a laparoscopic surgery.

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): NCT04207489


Contacts
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Contact: Hong Xu, Professor 18243052038 yd18243052038@163.com
Contact: Dong Yang, Master 714488468@qq.com

Sponsors and Collaborators
Jilin University
Investigators
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Principal Investigator: Dong Yang, Master First Hospital of Jilin University

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Responsible Party: Dong Yang, Assisted Investigator, Jilin University
ClinicalTrials.gov Identifier: NCT04207489    
Other Study ID Numbers: 130003
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 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
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases