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

NCT ID: NCT04207489

Last Updated: 2020-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2021-04-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Cancer Indocyanine Green

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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endoscopic submucosal injection of indocyanine green

endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Dong Yang

Assisted Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Yang, Master

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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the First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Xu, Professor

Role: CONTACT

18243052038

Dong Yang, Master

Role: CONTACT

Facility Contacts

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Dong Yang, Master

Role: primary

Other Identifiers

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130003

Identifier Type: -

Identifier Source: org_study_id

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