Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

May 12, 2019 updated by: LI XIN-XIANG, Fudan University

Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Lymphadenectomy without indocyanine green injection
Laparoscopic lymphadenectomy will be performed in a standard way.
Experimental: Lymphadenectomy with indocyanine green injection
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.
Drug: Indocyanine Green
Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The total number of lymph nodes retrieved
Time Frame: During the surgery
During the surgery
The positive number of lymph nodes retrieved
Time Frame: During the surgery
During the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
The duration of the operation to remove the lymph nodes
Time Frame: During the surgery
During the surgery
Detection rate of indocyanine green-positive para-aortic lymph node
Time Frame: During the surgery
During the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 26, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan FLGI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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