Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03854890
• Other study ID #: Fudan FLGI
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2019
• Source: Fudan University
• Contact: Xinxiang Li, MD,PhD
• Phone: +8613761291659
• Email: lxx1149[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Indocyanine Green
Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total number of lymph nodes retrieved		During the surgery
Primary	The positive number of lymph nodes retrieved		During the surgery
Secondary	The duration of the operation to remove the lymph nodes		During the surgery
Secondary	Detection rate of indocyanine green-positive para-aortic lymph node		During the surgery