Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

NCT03854890 | Unknown DMC

• 1 other identifier: Fudan FLGI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• The total number of lymph nodes retrieved

  During the surgery

• The positive number of lymph nodes retrieved

  During the surgery

Secondary Outcomes (2)

• The duration of the operation to remove the lymph nodes

  During the surgery

• Detection rate of indocyanine green-positive para-aortic lymph node

  During the surgery

Study Arms (2)

Lymphadenectomy without indocyanine green injection

NO INTERVENTION

Laparoscopic lymphadenectomy will be performed in a standard way.

Lymphadenectomy with indocyanine green injection

EXPERIMENTAL

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

Interventions

Indocyanine Green DRUG

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

Lymphadenectomy with indocyanine green injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of rectal carcinoma.
• Without multiple primary cancer.
• Without receiving neoadjuvant chemoradiotherapy.
• Sufficient organ function.
• Able to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xinxiang Li, MD,PhD

CONTACT

+8613761291659; lxx1149@163.com

Yanlei Ma, MD,PhD

CONTACT

+8613122680635; yanleima@live.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 26, 2019
• Study Start: July 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 14, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)