Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT03854890
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Last Update Submitted: 2019-05-12
• Last Update Posted: 2019-05-14
• Study Start: 2019-07-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lymphadenectomy with indocyanine green injection	Indocyanine Green	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.

Primary Outcome Measures

Name	Time	Method
The total number of lymph nodes retrieved	During the surgery
The positive number of lymph nodes retrieved	During the surgery

Secondary Outcome Measures

Name	Time	Method
Detection rate of indocyanine green-positive para-aortic lymph node	During the surgery
The duration of the operation to remove the lymph nodes	During the surgery

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China