Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03854890

Enrollment

100

Registered

2019-02-26

Start date

2019-07-01

Completion date

2020-05-01

Last updated

2019-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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.

Interventions

DRUGIndocyanine Green

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The total number of lymph nodes retrieved	During the surgery
The positive number of lymph nodes retrieved	During the surgery

Secondary

Measure	Time frame
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

Countries

China

Contacts

Primary ContactXinxiang Li, MD,PhD

lxx1149@163.com+8613761291659

Backup ContactYanlei Ma, MD,PhD

yanleima@live.cn+8613122680635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026