Detection of Lymphnodes Using ICG During RARP

NCT ID: NCT02163083

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lymphadenectomy using standard Methods

Lymphadenectomy will be performed as a standard procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lymphadenectomy using 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.

Group Type: EXPERIMENTAL

ICG

Intervention Type: PROCEDURE

Improvement of detection of positive lymphnodes

Interventions

ICG

Improvement of detection of positive lymphnodes

Intervention Type: PROCEDURE

Other Intervention Names

indocyanine green powder; Pulsion Medical Systems, München, Germany

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital Gronau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jörn H. Witt, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital Gronau

Locations

St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology

Gronau, Moellenweg 22, Germany

Countries

Germany

Other Identifiers

2013-609-f-S

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1157-6624

Identifier Type: -

Identifier Source: org_study_id