Surgical Guidance Technology for Urologic Cancer Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
Disqualifiers: Severely impaired renal function, Pregnancy, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This research study involves the use of two navigation systems, the 3D Slicer-based navigation system, and the Siemens Monaco systems, to simplify the complexity of image-guided lymphadenectomy procedures (surgery to remove one or more lymph nodes) in patients with urological cancer.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment 3D Slicer, SlicerIGT, Monaco, Urologic Lymphadenectomy, Pelvic lymphadenectomy, Groin dissection, Lymph node dissection for urologic cancer surgery?
Research shows that pelvic lymph node dissection, a part of the treatment, is effective in accurately staging prostate and bladder cancer, and can have a positive impact on cancer control. It is considered the most accurate method for staging lymph node involvement, which is crucial for determining the extent of cancer and planning further treatment.12345
Is surgical guidance technology for urologic cancer surgery safe?
Lymph node dissection, a part of urologic cancer surgery, can have complications like lymphocele (fluid collection), blood clots, and nerve or blood vessel injuries, but improvements in surgical techniques have reduced these risks. Laparoscopic methods, which are less invasive, show a lower complication rate and quicker recovery compared to open surgery.26789
How is urologic lymphadenectomy different from other treatments for urologic cancer?
Urologic lymphadenectomy, especially when performed using robotic or laparoscopic techniques, is a minimally invasive surgical approach that allows for precise removal of lymph nodes with potentially fewer complications and quicker recovery compared to traditional open surgery. This method is particularly useful for staging and treating various urologic cancers, offering a balance between effectiveness and reduced patient burden.210111213
Eligibility Criteria
This trial is for adults over 18 with confirmed or suspected urologic cancers (bladder, prostate, testicular, kidney, urethral, penile) who need lymph node removal surgery. They must have had a recent quality imaging scan at Brigham and Women's Hospital and be able to undergo general anesthesia without significant health risks.Inclusion Criteria
I am scheduled for a lymph node removal surgery for cancer in my bladder, prostate, testicle, kidney, urethra, or penis.
I am over 18 and have a possible diagnosis needing a biopsy in my urinary system.
Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
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Exclusion Criteria
History of hypersensitivity or other contraindication to contrast media
I cannot have general anesthesia due to health risks.
Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, to be judged at the discretion of the PI
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants undergo lymphadenectomy using the 3D Slicer and Siemens Monaco navigation systems
4 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (standard of care)
Treatment Details
Interventions
- 3D Slicer (Device)
- Monaco (Device)
- Urologic Lymphadenectomy (Procedure)
Trial OverviewThe study compares two navigation systems: the 3D Slicer-based system and the Siemens Monaco system. These are used during laparoscopic lymphadenectomy (lymph node removal surgery) to see if they can make this complex procedure simpler for patients with urological cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Urologic Lymphadenectomy in AMIGOExperimental Treatment2 Interventions
Participants will undergo Lymphadenectomy per standard of care with the navigation systems (3D Slicer and Monaco) used to locate the abnormal lymph node(s).
Urologic Lymphadenectomy is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Urologic Lymphadenectomy for:
- Urothelial carcinoma of the bladder
- Upper urinary tract urothelial carcinoma
- Prostate cancer
- Penile cancer
- Testicular cancer
🇪🇺 Approved in European Union as Urologic Lymphadenectomy for:
- Urothelial carcinoma of the bladder
- Upper urinary tract urothelial carcinoma
- Prostate cancer
- Penile cancer
- Testicular cancer
🇨🇦 Approved in Canada as Urologic Lymphadenectomy for:
- Urothelial carcinoma of the bladder
- Upper urinary tract urothelial carcinoma
- Prostate cancer
- Penile cancer
- Testicular cancer
🇯🇵 Approved in Japan as Urologic Lymphadenectomy for:
- Urothelial carcinoma of the bladder
- Upper urinary tract urothelial carcinoma
- Prostate cancer
- Penile cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brigham and Women's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
References
The role of pelvic lymphadenectomy in the management of prostate and bladder cancer. [2018]A pelvic lymph node dissection is commonly performed by urologists in the surgical management of prostate and bladder cancer. Identification of lymph node metastases provides important prognostic information for both diseases. Despite advances in radiographic imaging, a pelvic lymphadenectomy remains the most accurate method to stage lymph node involvement. In the past two decades, there has been an increase in the diagnosis of early stage prostate cancer, which has led some to omit a pelvic lymphadenectomy in patients thought to have low probability of positive lymph nodes. There is little debate, however, over the inclusion of a lymph node dissection in bladder cancer given the approximately 25% incidence of unsuspected nodal disease at the time of surgery. Controversy exists over the extent of an appropriate lymphadenectomy and its therapeutic efficacy. This review will examine the need, extent, and the potential prognostic and therapeutic benefits of a pelvic lymphadenectomy in prostate and bladder cancer.
Laparoscopic pelvic lymph node dissection: a review of 103 consecutive cases. [2019]Laparoscopic pelvic lymph node dissection is a recently introduced technique for the surgical evaluation of the regional pelvic lymph nodes in genitourinary malignancies. We report the results of a laparoscopic pelvic lymph node dissection performed on 103 consecutive patients for staging of clinically localized prostatic, bladder and penile carcinomas. In 20 patients (group 1) the adequacy of the laparoscopic pelvic lymph node dissection was evaluated with a subsequent open dissection. In this group 87 to 95% of the lymph nodes within a modified template could be reliably removed laparoscopically. In 73 patients (group 2) laparoscopic pelvic lymph node dissection was performed as a solitary operation. Mean hospitalization was 1.6 +/- 2.4 days, while postoperative narcotic requirements were minimal. Mean operative time for bilateral laparoscopic pelvic lymph node dissection was 156 +/- 41.2 minutes. The overall complication rate in these 2 groups was 13.5%. Group 3 includes 10 patients (9.7% of the total) in whom laparoscopic pelvic lymph node dissection was unsuccessful. The minimally invasive surgical techniques of laparoscopic pelvic lymph node dissection seem to provide adequate staging accuracy in patients with genitourinary neoplasms. The complication rate and recovery period appear to be decreased relative to those for open surgical lymphadenectomy.
The value of regional lymph node dissection in genitourinary cancer. [2019]Regional lymph node dissection in the management of genitourinary (GU) neoplasms is controversial but is based on a 17 year clinical experience and the achievement of survival figures as good or better than those achieved by any other modality of therapy. Lymphadenectomy has proved to be effective in curing patients with metastatic testicular cancer, renal cell carcinoma and transitional cell carcinoma. Its efficacy in prostate cancer is much less certain and remains largely a staging procedure.
Lymphadenectomy for bladder cancer: indications and controversies. [2011]Pelvic lymph node dissection (PLND) at the time of cystectomy remains the most accurate method of staging and can have a positive impact on cancer control, and there is general agreement as to its necessity at the time of surgery. There is, however, a lack of consensus regarding the terminology of PLND and controversy concerning the optimal extent of lymph node dissection, especially because recent investigations have suggested a survival benefit with extended PLND.
Complete Tissue Submission to Increase Lymph Node Detection in Pelvic Lymph Node Packets Submitted for Patients Undergoing Radical Prostatectomy and Radical Cystectomy. [2017]Pelvic lymphadenectomy has prognostic and therapeutic implications in both bladder and prostate cancer. Pelvic lymphadenectomy specimens are fatty and identification of lymph nodes (LNs) can be difficult during the grossing process. We investigated the benefit of a new grossing method requiring entire LN packet submission.
Radical open inguinal lymphadenectomy for penile carcinoma: surgical technique, early complications and late outcomes. [2014]We reviewed our recent experience with inguinal lymph node dissection in patients with penile cancer to assess the incidence and magnitude of complications caused by this procedure.
Complications of lymphadenectomy in urologic surgery. [2011]Lymphadenectomy in urologic surgery provides accurate staging and may be therapeutic in some patients with lymph node metastases. In addition to the associated cost, pelvic lymph node dissection (PLND) has the potential for morbidity. This article focuses on the complications associated with PLND, including lymphocele, thromboembolic events, ureteral injury, nerve injury, vascular injury, and lymphedema. With improvements in surgical technique and perioperative care, the morbidity associated with lymphadenectomy may be minimized.
Adherence to guideline recommendations for lymph node dissection in squamous cell carcinoma of the penis: Effect on survival and complication rates. [2020]We analyzed adherence rates to contemporary guidelines regarding inguinal lymph node dissection (ILND) for squamous cell carcinoma of the penis, as well as ILND association with cancer specific mortality (CSM), and complication rates.
Standardized comparison of robot-assisted limited and extended pelvic lymphadenectomy for prostate cancer. [2022]WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Extended pelvic lymphadenectomy is the present standard of care according to European Association of Urology guidelines. Extended dissection improves staging, removes more metastatic lymph nodes, and potentially has therapeutic benefits. Previous reports have examined the morbidity of extended dissection compared with a more limited dissection in the open and laparoscopic setting. While some have suggested an increased complication rate with extended node dissection, others have not. This represents the first study focused on comparing the complications associated with the extent of node dissection using the modified Clavien system and Martin criteria in the literature on robot-assisted surgery. In a single surgeon series, we found no statistically significant differences in complications. With careful anatomic dissection, robot-assisted extended lymph node dissection can be performed safely and effectively, although operating time and length of hospital of stay are slightly increased.
A nomogram to predict the duration of drainage in patients with penile cancer treated with inguinal lymph node dissection. [2011]We developed a nomogram to predict the duration of drainage in patients with penile cancer treated with inguinal lymph node dissection.
Robot assisted lymphadenectomy in urology: pelvic, retroperitoneal and inguinal. [2022]Lymph node dissection represents an essential surgical step in the treatment of the most commonly treated urological cancers. The introduction of robotic surgery has lead to the possibility of treating these diseases with a minimally invasive surgical approach, but the surgical principles of open surgery need to be carefully respected in order to achieve comparable oncological results. Therefore, the robotic approach to urological cancers must include a carefully performed lymph node dissection when indicated. In the current manuscript we reviewed the current indications and extensions of lymph node dissection in prostate, bladder, testicular, upper urinary tract, renal and penile cancers respectively, with a special focus on the state of the art surgical technique for each procedure.
Comparative effectiveness of minimally invasive versus open lymphadenectomy in urological cancers. [2014]With increasing adoption of minimally invasive surgical techniques in urologic oncology, the efficacy, safety, and adequacy of lymphadenectomy were reviewed for studies about prostate, bladder, kidney, upper tract urothelial, testicular, and penile cancer published in the past 18 months.
Complications after laparoscopic pelvic lymphadenectomy: CT diagnosis. [2016]Laparoscopic dissection of pelvic lymph nodes has become an accepted alternative to open lymphadenectomy for staging of genitourinary tumors. This study reviews the CT findings in patients with major complications detected after laparoscopic dissection.