Robotic Surgery for Testicular Seminoma

Recruiting in Palo Alto (17 mi)

Overseen by Robert Hamilton, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Health Network, Toronto

Disqualifiers: Metastasis, Previous chemotherapy, Psychiatric illnesses, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will investigate the safety and efficacy of using robotic retroperitoneal lymph node dissection (R-RPLND), a minimally invasive surgical approach, as the first-line of treatment for stage IIA/B (or equivalent) seminoma patients. R-RPLND will be trialed as an alternative to chemotherapy, radiation therapy (for seminoma patients) and open RPLND in this study.

Will I have to stop taking my current medications?

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 Robotic Retroperitoneal Lymph Node Dissection (RPLND) for testicular seminoma?

Research shows that robotic-assisted retroperitoneal lymph node dissection (R-RPLND) is a promising surgical option for testicular cancer, offering less recovery time and fewer complications compared to traditional open surgery. Studies indicate that it is a safe and effective minimally invasive treatment for managing testicular cancer. ^{1 2 3 4 5}

Is robotic surgery for testicular seminoma safe?

Robotic-assisted retroperitoneal lymph node dissection (R-RPLND) is considered a safe and minimally invasive option for testicular cancer, with studies showing it has less risk of complications compared to traditional open surgery. ^{1 2 4 6 7}

How is robotic retroperitoneal lymph node dissection different from other treatments for testicular seminoma?

Robotic retroperitoneal lymph node dissection (RPLND) is a minimally invasive surgical option for testicular cancer that uses robotic assistance to reduce recovery time and complications compared to traditional open surgery. This approach offers precision and less morbidity, making it a novel alternative to the more invasive open RPLND. ^{1 2 5 8 9}

Research Team

Robert Hamilton, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Eligibility Criteria

This trial is for men with a specific type of testicular cancer (seminoma) that has spread to nearby lymph nodes but not beyond. They must have had surgery to remove the tumor, no metastasis in the chest, and meet certain criteria regarding tumor markers. It's not for those who've had extensive previous treatments or surgeries, other serious illnesses, or are unsuitable for robotic surgery.

Inclusion Criteria

I have a lymph node in my abdomen that is 5cm or smaller, confirmed by a scan.

Willing to comply with follow-up protocol

I am planning to undergo surgery to remove lymph nodes for cancer treatment.

Exclusion Criteria

My doctor says I can't have surgery using a robot.

I have large lymph nodes in my abdomen.

I have had chemotherapy or radiotherapy targeting the area behind my stomach.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic retroperitoneal lymph node dissection (R-RPLND) using the DaVinci robotic surgical system

Surgery duration (an average of 8 hours)

1 visit (in-person)

Post-operative Recovery

Participants recover from surgery and are monitored for immediate post-operative complications

2 days

Inpatient stay

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

5 years

Regular follow-up visits

Treatment Details

Interventions

• Robotic Retroperitoneal Lymph Node Dissection (RPLND) (Procedure)

Trial Overview The study tests a minimally invasive surgical technique called Robotic Retroperitoneal Lymph Node Dissection (R-RPLND) as an initial treatment option instead of chemotherapy or radiation. The goal is to see if this approach is safe and effective for stage IIA/B seminoma patients.

Participant Groups

Group I: Robotic Retroperitoneal Lymph Node Dissection Experimental Treatment 1 Intervention

Robotic retroperitoneal lymph node dissection performed using the DaVinci robotic surgical system.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Princess Margaret Cancer Centre Toronto, Canada

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1555

Patients Recruited

526,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of robotic retroperitoneal lymph node dissection in testicular cancer: a systematic review and meta-analysis. [2023] To compare the safety and efficacy of robotic-assisted retroperitoneal lymph node dissection (RA-RPLND) versus non-robotic retroperitoneal lymph node dissection in testicular cancer.

2. United States pubmed.ncbi.nlm.nih.gov

Robotic-assisted retroperitoneal lymph node dissection for testicular cancer. [2023] Robotic-assisted retroperitoneal lymph node dissection (R-RPLND) is an emerging surgical option for testicular cancer with less morbidity than open RPLND. We outline the operative technique used at our center and review contemporary evidence in the advancement of R-RPLND.

3. United States pubmed.ncbi.nlm.nih.gov

Robot-Assisted Retroperitoneal Lymphadenectomy in Testicular Cancer Treatment: A Systematic Review. [2019] Retroperitoneal lymph node dissection (RPLND) in testicular cancer is a documented treatment along with active surveillance and chemotherapy. This study aims to summarize the current evidence on the use of Robot-assisted RPLND (RARPLND) in comparison with the laparoscopic and open approach.

4. England pubmed.ncbi.nlm.nih.gov

Robot-assisted retroperitoneal lymph node dissection: a systematic review of perioperative outcomes. [2023] To assess the safety and feasibility of robot-assisted retroperitoneal lymph node dissection (R-RPLND) and to compare the perioperative outcomes of R-RPLND with open RPLND (O-RPLND), as RPLND forms an integral part of the management of testis cancer and R-RPLND is a minimally invasive treatment option for this disease.

5. Egypt pubmed.ncbi.nlm.nih.gov

A Review of Outcomes and Technique for the Robotic-Assisted Laparoscopic Retroperitoneal Lymph Node Dissection for Testicular Cancer. [2022] The robotic-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) represents a new frontier in the surgical management of testicular cancer in the realm of minimally invasive urologic oncology. We aimed to review the early outcomes as compared to the laparoscopic and open approaches as well as describe the operative technique for the R-RPLND.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Phase 2 Single-arm Trial of Primary Retroperitoneal Lymph Node Dissection in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B (PRIMETEST). [2023] Primary retroperitoneal lymph node dissection (RPLND) for clinical stage (CS) IIA/B seminoma without adjuvant treatment is an experimental treatment to avoid radiotherapy- or chemotherapy-related toxicity from standard treatment.

7. England pubmed.ncbi.nlm.nih.gov

A comparative analysis of robotic vs laparoscopic retroperitoneal lymph node dissection for testicular cancer. [2022] To compare the safety and perioperative outcomes of robotic retroperitoneal lymph node dissection (R-RPLND) vs laparoscopic RPLND (L-RPLND).

8. United States pubmed.ncbi.nlm.nih.gov

Indications, evolving technique, and early outcomes with robotic retroperitoneal lymph node dissection. [2019] Examine and discuss indications, technique, and outcomes for robotic retroperitoneal lymph node dissection (RPLND) for testicular cancer.

9. United States pubmed.ncbi.nlm.nih.gov

Robotic retroperitoneal lymph node dissection for testicular cancer: feasibility and latest outcomes. [2020] Robotic-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) is gaining acceptance as an alternative to open and laparoscopic RPLND for the treatment of testicular cancer. We discuss the current state of R-RPLND and summarize the latest relevant literature regarding the feasibility of this operation.