Fluorescent Lymphography-Guided Lymphadenectomy In Laparoscopic Proctectomy

NCT ID: NCT03854890

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-05-01

Brief Summary

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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

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lymphadenectomy without indocyanine green injection

Laparoscopic lymphadenectomy will be performed in a standard way.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Indocyanine Green

Intervention Type DRUG

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

Interventions

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Indocyanine Green

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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LI XIN-XIANG

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xinxiang Li, MD,PhD

Role: CONTACT

+8613761291659

Yanlei Ma, MD,PhD

Role: CONTACT

+8613122680635

Other Identifiers

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Fudan FLGI

Identifier Type: -

Identifier Source: org_study_id

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