Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

NCT06258486 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ICG lymphatic
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lymphocele; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Drain output <100 mL

  A sample of 12 recent patients receiving the current standard procedure had a mean drain volume for the first 24 hours of 218 mL and standard deviation of 102. With a hoped-for reduction to \<100 mL/ 24 hr mean in the treatment arm, there would be 99% power to detect a difference, and 80% power to detect a difference of 57 mL between treatment and control arms. Given the small sample used for this power estimate, we believe that it is appropriate to power for a range of potential standard deviations and potential differences.

  2 weeks

Secondary Outcomes (1)

• Lymphocele formation

  4 weeks

Study Arms (2)

ICG Injection

EXPERIMENTAL

This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.

Drug: ICG injection; Procedure: Prostatectomy with pelvic lymph node dissection

ICG non-injection

PLACEBO COMPARATOR

This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.

Other: Non-Injection/Control; Procedure: Prostatectomy with pelvic lymph node dissection

Interventions

ICG injection DRUG

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.

ICG Injection

Non-Injection/Control OTHER

No ICG injection

ICG non-injection

Prostatectomy with pelvic lymph node dissection PROCEDURE

Robotic assisted prostatectomy with pelvic lymph node dissection

ICG Injection; ICG non-injection

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing robotic assisted laparoscopic lymph node dissection

You may not qualify if:

• Patient not undergoing extended lymph node dissection
• History of allergy to iodides

Sponsors & Collaborators

• Kaiser Permanente: lead

Related Publications (4)

• Motterle G, Morlacco A, Zanovello N, Ahmed ME, Zattoni F, Karnes RJ, Dal Moro F. Surgical Strategies for Lymphocele Prevention in Minimally Invasive Radical Prostatectomy and Lymph Node Dissection: A Systematic Review. J Endourol. 2020 Feb;34(2):113-120. doi: 10.1089/end.2019.0716.

  PMID: 31797684 RESULT

• Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol. 2012 Jul;62(1):1-15. doi: 10.1016/j.eururo.2012.02.029. Epub 2012 Feb 24.

  PMID: 22405509 RESULT

• Tsaur I, Thomas C. Risk factors, complications and management of lymphocele formation after radical prostatectomy: A mini-review. Int J Urol. 2019 Jul;26(7):711-716. doi: 10.1111/iju.13964. Epub 2019 Apr 2.

  PMID: 30939628 RESULT

• Gloger S, Ubrig B, Boy A, Leyh-Bannurah SR, Siemer S, Arndt M, Stolzenburg JU, Franz T, Oelke M, Witt JH. Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy. J Urol. 2022 Aug;208(2):333-340. doi: 10.1097/JU.0000000000002693. Epub 2022 Apr 15.

  PMID: 35422136 RESULT

MeSH Terms

Conditions

Lymphocele; Prostatic Neoplasms

Interventions

Prostatectomy

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David Finley, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Finley, MD

CONTACT

310-210-4555; david.s.finley@kp.org

Irene Chen, MD

CONTACT

323-783-2065; irene.k.chen@kp.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into ICG versus no ICG injection after pelvic lymphadenectomy is completed.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 14, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share