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Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03854890
Recruitment Status : Unknown
Verified February 2019 by LI XIN-XIANG, Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
LI XIN-XIANG, Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Indocyanine Green Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluorescent Lymphography-Guided Lymphadenectomy Using Indocyanine Green During Laparoscopic Radical Resection Of Rectal Cancer
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : May 1, 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The total number of lymph nodes retrieved [ Time Frame: During the surgery ]
  2. The positive number of lymph nodes retrieved [ Time Frame: During the surgery ]

Secondary Outcome Measures :
  1. The duration of the operation to remove the lymph nodes [ Time Frame: During the surgery ]
  2. Detection rate of indocyanine green-positive para-aortic lymph node [ Time Frame: During the surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT03854890


Contacts
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Contact: Xinxiang Li, MD,PhD +8613761291659 lxx1149@163.com
Contact: Yanlei Ma, MD,PhD +8613122680635 yanleima@live.cn

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: LI XIN-XIANG, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03854890    
Other Study ID Numbers: Fudan FLGI
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: February 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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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases