Sutureless, Clampless Partial Nephrectomy for Kidney Cancer

(CASPIAN Trial)

Overseen By Pravalika Manda

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Bleeding disorder, Liver dysfunction, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

59 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new surgical method for kidney cancer, called sutureless, clampless partial nephrectomy, which avoids using clamps and stitches during partial kidney removal. The goal is to determine if this technique is safe and effective while potentially reducing long-term kidney problems. People with kidney cancer who have a tumor 7 cm or smaller and no more than one other cancer might be suitable for this trial. The research aims to make kidney surgeries safer and preserve more kidney function. As an unphased trial, this study offers patients the opportunity to contribute to pioneering research that could improve surgical outcomes for future kidney cancer patients.

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 team or your doctor.

What prior data suggests that this technique is safe for kidney cancer surgery?

Research has shown that a sutureless, clampless partial nephrectomy is generally well-tolerated. This method avoids clamping the kidney's main blood vessel and does not use stitches, which can lower risks. For instance, one study found that omitting stitches did not lead to more complications or harm kidney function. Another study focused on important outcomes like blood loss and major complications, and the results were positive. Overall, evidence suggests this procedure may be safe for patients, but it is still under study for wider use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sutureless, clampless partial nephrectomy for kidney cancer because it offers a less invasive surgical option. Traditional partial nephrectomies often involve clamping the renal artery and suturing, which can lead to complications and longer recovery times. This new approach eliminates the need for clamps and sutures, potentially reducing surgical trauma and speeding up recovery. By minimizing the impact on the kidney during surgery, this technique could improve patient outcomes and reduce hospital stays, making it a promising alternative to current methods.

What evidence suggests that this technique is effective for kidney cancer?

Research has shown that kidney surgeries without clamps or stitches, known as sutureless, clampless partial nephrectomies, can effectively treat kidney cancer. One study found that this method left behind only 2.4% of cancer, with very few cases of recurrence, indicating effective tumor removal. Another review demonstrated that this approach could help protect kidney function by avoiding clamps and stitches, which can damage kidney tissue. A meta-analysis suggested that sutureless techniques lead to good surgical outcomes, comparing well to traditional methods with stitches. These findings support the potential for this new technique, which participants in this trial will undergo, to effectively treat cancer while preserving kidney health. ^{1 2 4 6 7}

Who Is on the Research Team?

Padraic O'Malley, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Adults over 18 with kidney masses ≤ 7 cm, likely renal cell carcinoma (cT1-3 N0 M0), no more than one active cancer, and not on end-stage liver or kidney disease treatments. Participants need normal blood counts, must consent to the study's procedures, use contraception if of childbearing potential, and cannot be pregnant or breastfeeding.

Inclusion Criteria

Adequate laboratory test results: Platelets > 50,000/µL, Hemoglobin > 9.0 g/dL

I am having surgery to remove part of my kidney for a tumor 7 cm or smaller.

I have no more than one active cancer.

Exclusion Criteria

Prisoners, involuntarily incarcerated subjects, or compulsorily detained subjects for treatment of psychiatric or physical illness

Subjects of childbearing potential unwilling or unable to use acceptable contraception for the study period and for at least 2 weeks after surgery

Confirmed pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo clampless, sutureless robotic partial nephrectomy

1 day

1 visit (in-person)

Immediate Post-surgery Follow-up

Participants are monitored for renal dysfunction and other immediate post-surgery outcomes

1 day

1 visit (in-person)

Short-term Follow-up

Participants are monitored for renal dysfunction and other outcomes 2-3 weeks post-surgery

2-3 weeks

1 visit (in-person)

Mid-term Follow-up

Participants are monitored for transfusion rate and other outcomes approximately 4 weeks post-surgery

4 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for renal dysfunction 6 months post-surgery

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sutureless, Clampless Partial Nephrectomy

Trial Overview The trial is testing a new way to remove part of the kidney in patients with small tumors without using clamps or stitches. This method aims to preserve kidney function by avoiding damage from traditional surgical techniques. The safety and effectiveness for widespread use are being evaluated.

How Is the Trial Designed?

Group I: Clampless, sutureless robotic partial nephrectomy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. oaepublish.com oaepublish.com/articles/2574-1225.2025.52

Sutureless clampless partial nephrectomy: where do we ... This review aims to evaluate the current literature on sutureless clampless partial nephrectomy (sl-oc PN) and assess its potential ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590089724000033

Sutureless clampless robot-assisted partial nephrectomy ... The current paper is presented to show the use of RAPN surgical technique for T2 renal masses with no clamping of the renal artery and no sliding suture.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-04311

Clampless and Sutureless Robotic Partial Nephrectomy for ... This clinical trial evaluates the safety and effectiveness of clampless and sutureless robotic partial nephrectomy for the treatment of renal (kidney) cell ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12385006/

Off-Clamp Robotic-Assisted Partial Nephrectomy Oncologic outcomes were favorable, with a positive surgical margin rate (PSM) of 2.4% and two cases of tumor recurrences (0.36%) documented at a ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.713645/full

Comparison of Sutureless Versus Suture Partial ... This meta-analysis was conducted to compare the function and perioperative outcomes of suture and sutureless PN for T1 RCC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9913582/

Sutureless Purely Off-Clamp Robot-Assisted Partial ... Suturing the kidney after tumor excision can be omitted most of the time, without increasing the risks of complications or jeopardizing renal function.

7. mdpi.com mdpi.com/2075-4418/14/15/1579

Renal Function Preservation in Purely Off-Clamp ... The aim of our study is to evaluate the effectiveness and safety of a sutureless off-clamp robot-assisted partial nephrectomy (sl-oc RAPN), particularly its ...