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Trial Title:
Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
NCT ID:
NCT06258486
Condition:
Lymphocele
Prostate Cancer
Conditions: Official terms:
Lymphocele
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will be randomized into ICG versus no ICG injection after pelvic lymphadenectomy
is completed.
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
The investigator and participant will not know which arm the patient is randomized into
while undergoing the surgery. It isn't until the surgery is complete that the patient
will be randomized into either ICG injection versus not.
Intervention:
Intervention type:
Drug
Intervention name:
ICG injection
Description:
Patient will have a green dye (ICG) injected into the lymph node to better visualize
non-sealed leaks in order to pre-emptively seal any lymphatic leaks.
Arm group label:
ICG Injection
Intervention type:
Other
Intervention name:
Non-Injection/Control
Description:
No ICG injection
Arm group label:
ICG non-injection
Intervention type:
Procedure
Intervention name:
Prostatectomy with pelvic lymph node dissection
Description:
Robotic assisted prostatectomy with pelvic lymph node dissection
Arm group label:
ICG Injection
Arm group label:
ICG non-injection
Summary:
Goal is to determine whether intraoperative ICG injection can be used to identify and
reduce formation of symptomatic lymphoceles in patients receiving robot-assisted
prostatectomy.
Detailed description:
The goal of this clinical trial is to determine whether intraoperative ICG injection can
be used to identify and reduce formation of symptomatic lymphoceles in patients receiving
robot-assisted prostatectomy. The main question is if it could improve patients' quality
of life and infection risk post-surgery. It would also help to decrease emergency room
visits as well as additional procedures. Researchers will compare those who receive the
ICG and those who do not.
Patients will be randomized into the ICG arm versus no ICG arm after pelvic
lymphadenectomy is done.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient undergoing robotic assisted laparoscopic lymph node dissection
Exclusion Criteria:
- Patient not undergoing extended lymph node dissection
- History of allergy to iodides
Gender:
Male
Minimum age:
45 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
February 2024
Completion date:
February 2026
Lead sponsor:
Agency:
Kaiser Permanente
Agency class:
Other
Source:
Kaiser Permanente
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06258486
