Robotic Surgery for Testicular Seminoma

Overseen By Robert Hamilton, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastasis, Previous chemotherapy, Psychiatric illnesses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration (an average of 8 hours)

25 Participants Needed

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.

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)

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

Robotic-assisted retroperitoneal lymph node dissection (RA-RPLND) is associated with shorter hospital stays, less blood loss, and fewer overall complications compared to traditional open surgery, based on a systematic review of 7 studies with 862 patients.

While RA-RPLND shows better lymph node yields than laparoscopic methods, it has similar outcomes in terms of operation time, lymph node positivity rates, and postoperative complications, indicating its safety and efficacy for treating testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of robotic retroperitoneal lymph node dissection in testicular cancer: a systematic review and meta-analysis. Ge, S., Zeng, Z., Li, Y., et al.[2023]

Robotic-assisted retroperitoneal lymph node dissection (R-RPLND) is a promising surgical option for testicular cancer that shows less morbidity compared to traditional open RPLND, making it a safer choice for patients.

R-RPLND has been effectively used not only for early-stage testicular cancer but also for low-volume, clinical stage II disease, offering benefits such as shorter hospital stays and reduced blood loss while maintaining low complication rates and effective cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted retroperitoneal lymph node dissection for testicular cancer. Gereta, S., Hung, M., Hu, JC.[2023]

Robot-assisted retroperitoneal lymph node dissection (RARPLND) for stage I-IIB testicular cancer showed no retroperitoneal recurrence over an average follow-up of 21.2 months, indicating effective treatment outcomes.

RARPLND demonstrated similar results to laparoscopic techniques and better perioperative outcomes compared to open surgery, with a low complication rate of 8%, suggesting it is a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Retroperitoneal Lymphadenectomy in Testicular Cancer Treatment: A Systematic Review. Tselos, A., Moris, D., Tsilimigras, DI., et al.[2019]

Robot-assisted retroperitoneal lymph node dissection (R-RPLND) shows acceptable safety and feasibility, with major complication rates of 4.1% for primary cases and 8.5% for post-chemotherapy cases, based on a systematic review of 4222 patients.

R-RPLND is associated with significantly lower transfusion rates (0.9% vs 14.5%) and fewer overall complications (7.8% vs 18.5%) compared to open RPLND (O-RPLND), although there is a notable conversion rate to open surgery in post-chemotherapy cases (9.0%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted retroperitoneal lymph node dissection: a systematic review of perioperative outcomes. Garg, H., Mansour, AM., Psutka, SP., et al.[2023]

Robotic-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) shows promising early outcomes for treating clinical stage I nonseminomatous germ cell tumors, offering similar recovery benefits as traditional laparoscopic methods while enhancing surgical precision and visualization.

Despite its advantages, further large-scale studies are necessary to confirm R-RPLND's efficacy and safety before it can replace the open approach as the standard treatment for low-stage testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Outcomes and Technique for the Robotic-Assisted Laparoscopic Retroperitoneal Lymph Node Dissection for Testicular Cancer. Schwen, ZR., Gupta, M., Pierorazio, PM.[2022]

The PRIMETEST trial evaluated primary retroperitoneal lymph node dissection (RPLND) as an alternative to chemotherapy or radiation for patients with clinical stage IIA/B seminoma, but it did not meet its primary endpoint of less than 30% recurrence, with a recurrence rate of 30% after a median follow-up of 32 months.

Despite not meeting the primary goal, the trial suggests that RPLND may still be beneficial for carefully selected patients, as it achieved a progression-free survival rate of 70%, indicating potential for avoiding the side effects of conventional treatments.

NCBI (Pubmed)

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). Hiester, A., Che, Y., Lusch, A., et al.[2023]

In a study comparing robotic retroperitoneal lymph node dissection (R-RPLND) and laparoscopic RPLND (L-RPLND) in 37 patients with stage I testicular cancer, both techniques showed similar safety profiles and perioperative outcomes, including operative time and complication rates.

The findings suggest that R-RPLND is comparable to L-RPLND, but it is still uncertain whether R-RPLND provides any additional benefits over the traditional laparoscopic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative analysis of robotic vs laparoscopic retroperitoneal lymph node dissection for testicular cancer. Harris, KT., Gorin, MA., Ball, MW., et al.[2022]

Robotic retroperitoneal lymph node dissection (RPLND) is emerging as a promising alternative to traditional open RPLND for testicular cancer, aiming to reduce surgery-related complications while maintaining similar effectiveness in cancer treatment.

Current evidence suggests that robotic RPLND can effectively stage and treat testicular cancer, although more extensive studies with longer follow-up are needed to fully confirm its oncologic efficacy compared to open surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications, evolving technique, and early outcomes with robotic retroperitoneal lymph node dissection. Werntz, RP., Pearce, SM., Eggener, SE.[2019]

Robotic-assisted laparoscopic retroperitoneal lymph node dissection (R-RPLND) is an effective treatment option for high-risk, clinical stage I testicular cancer, showing similar complication rates to traditional open RPLND but with benefits like shorter hospital stays and less blood loss.

As R-RPLND becomes more common in high-volume medical centers, further research, including head-to-head trials against open RPLND, will be necessary to fully understand its long-term effectiveness in treating testicular cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic retroperitoneal lymph node dissection for testicular cancer: feasibility and latest outcomes. Mittakanti, HR., Porter, JR.[2020]

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]

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

Robotic-assisted retroperitoneal lymph node dissection for testicular cancer. [2023]

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

Robot-Assisted Retroperitoneal Lymphadenectomy in Testicular Cancer Treatment: A Systematic Review. [2019]

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

Robot-assisted retroperitoneal lymph node dissection: a systematic review of perioperative outcomes. [2023]

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]

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]

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

A comparative analysis of robotic vs laparoscopic retroperitoneal lymph node dissection for testicular cancer. [2022]

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

Indications, evolving technique, and early outcomes with robotic retroperitoneal lymph node dissection. [2019]

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

Robotic retroperitoneal lymph node dissection for testicular cancer: feasibility and latest outcomes. [2020]