Detection of Lymphnodes Using ICG During RARP

NCT02163083 | Completed

• 2 other identifiers: U1111-1157-66242013-609-f-S
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The total number of detection rate of (positive) lymph nodes using ICG

  during the surgery

Secondary Outcomes (1)

• Measurements of the time, that takes to remove the lymph nodes

  During the surgery

Other Outcomes (1)

• Determine the anatomical location of the ICG-positive lymph node

  During th surgery

Study Arms (2)

Lymphadenectomy using standard Methods

NO INTERVENTION

Lymphadenectomy will be performed as a standard procedure

Lymphadenectomy using ICG

EXPERIMENTAL

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.

Procedure: ICG

Interventions

ICG PROCEDURE

Improvement of detection of positive lymphnodes

Also known as: indocyanine green powder, Pulsion Medical Systems, München, Germany

Lymphadenectomy using ICG

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital Gronau: lead

Study Sites (1)

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

Gronau, Moellenweg 22, 48599, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Jörn H. Witt, MD

  St. Antonius Hospital Gronau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2017
• Last Updated: January 18, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)