Detection of Lymphnodes Using ICG During RARP

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: ICG

• Registration Number: NCT02163083
• Lead Sponsor: St. Antonius Hospital Gronau

Brief Summary

The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).

Detailed Description

ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-13
• Study Start: 2014-08
• Primary Completion: 2015-04
• Study Completion: 2017-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• Histologically confirmed locally limited prostate cancer;
• Intermediate or high risk tumor
• Recommended and planned prostatectomy;
• Completed and signed written consent;
• Voluntarily agreement to participate in this study
• Age of the study participants ≥ 18 years.

Exclusion Criteria

• Allergic reaction to active ingredient (indocyanine green);
• Iodine allergy;
• Hyperthyroidism;
• High-grade renal impairment;
• High-grade hepatic insufficiency;
• Unwillingness to the storage and disclosure of pseudonymous disease and personal data
• psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lymphadenectomy using ICG	ICG	A fluorescent dye (indocyanine green) will be ultrasound-controlled preoperatively injected in the prostate. During robot-assisted radical intervention by DaVinci ® robot the lymphadenectomy is performed using the fluorescence lymphography.

Primary Outcome Measures

Name	Time	Method
The total number of detection rate of (positive) lymph nodes using ICG	during the surgery

Secondary Outcome Measures

Name	Time	Method
Measurements of the time, that takes to remove the lymph nodes	During the surgery

Trial Locations

Locations (1)

St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology; 🇩🇪 Gronau, Moellenweg 22, Germany