Back to resultsFluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of rectal carcinoma.
- Without multiple primary cancer.
- Without receiving neoadjuvant chemoradiotherapy.
- Sufficient organ function.
- Able to provide written informed consent.
Exclusion Criteria:
- Younger than 18 years or older than 75 years
- Synchronous or metachronous malignancy within 5 years.
- Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
- Patients with a history of pelvic irradiation.
- ASA (American Society of Anesthesiologists) grade IV or V.
- Women who are pregnant (confirmed by serum β-Human Chorionic Gonadotropin in women of reproductive age) or breast feeding.
- Severe mental illness.
- Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
- Patients who received steroid therapy within one month.
- Patients or family members misunderstand the conditions and goals of this study.
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Lymphadenectomy without indocyanine green injection
Lymphadenectomy with indocyanine green injection
Arm Description
Laparoscopic lymphadenectomy will be performed in a standard way.
Injection of indocyanine green to the submucosal layer around rectal cancer 1 day before surgery. Laparoscopic proctectomy with lymph nodes dissection will be performed under near-infrared imaging.
Outcomes
Primary Outcome Measures
The total number of lymph nodes retrieved
The positive number of lymph nodes retrieved
Secondary Outcome Measures
The duration of the operation to remove the lymph nodes
Detection rate of indocyanine green-positive para-aortic lymph node
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03854890
Brief Title
Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy
Official Title
Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the number of lymph nodes retrieved with or without the use of intraoperative fluorescence lymphography in laparoscopic radical resection of rectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphadenectomy without indocyanine green injection
Arm Type
No Intervention
Arm Description
Laparoscopic lymphadenectomy will be performed in a standard way.
Arm Title
Lymphadenectomy with indocyanine green injection
Arm Type
Experimental
Arm Description
Injection of indocyanine green to the submucosal layer around rectal cancer 1 day before surgery. Laparoscopic proctectomy with lymph nodes dissection will be performed under near-infrared imaging.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.
Primary Outcome Measure Information:
Title
The total number of lymph nodes retrieved
Time Frame
During the surgery
Title
The positive number of lymph nodes retrieved
Time Frame
During the surgery
Secondary Outcome Measure Information:
Title
The duration of the operation to remove the lymph nodes
Time Frame
During the surgery
Title
Detection rate of indocyanine green-positive para-aortic lymph node
Time Frame
During the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of rectal carcinoma.
Without multiple primary cancer.
Without receiving neoadjuvant chemoradiotherapy.
Sufficient organ function.
Able to provide written informed consent.
Exclusion Criteria:
Younger than 18 years or older than 75 years
Synchronous or metachronous malignancy within 5 years.
Patients with Intestinal obstruction or perforation or bleeding who require emergency surgery.
Patients with a history of pelvic irradiation.
ASA (American Society of Anesthesiologists) grade IV or V.
Women who are pregnant (confirmed by serum β-Human Chorionic Gonadotropin in women of reproductive age) or breast feeding.
Severe mental illness.
Patients with severe emphysema, interstitial pneumonia, or ischemic heart disease who can not tolerate surgery.
Patients who received steroid therapy within one month.
Patients or family members misunderstand the conditions and goals of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinxiang Li, MD,PhD
Phone
+8613761291659
Email
lxx1149@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanlei Ma, MD,PhD
Phone
+8613122680635
Email
yanleima@live.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy
We'll reach out to this number within 24 hrs