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

Trial Summary

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 data supports the effectiveness of the treatment Sutureless, Clampless Partial Nephrectomy for Kidney Cancer?

Research shows that the sutureless, clampless partial nephrectomy technique is feasible and safe, with positive surgical and functional outcomes for kidney tumors. Studies indicate it can effectively remove tumors while minimizing complications and preserving kidney function. ^{1 2 3 4 5}

Is sutureless, clampless partial nephrectomy safe for humans?

Research shows that sutureless, clampless partial nephrectomy is generally safe for humans, with studies indicating it can protect kidney function better than conventional methods and has a similar safety profile. ^{1 2 4 5 6}

How is the sutureless, clampless partial nephrectomy treatment different from other treatments for kidney cancer?

This treatment is unique because it involves removing part of the kidney without using stitches (sutureless) or clamping blood vessels (clampless), which can reduce the risk of complications and preserve kidney function better than traditional methods that use clamping and suturing. ^{1 3 4 5 7}

What is the purpose of this trial?

During partial nephrectomy surgery, efforts at minimizing ischemia while maximizing renal parenchymal volume are desirable to preserve renal function1,2. Not only clamping of the hilum but the renorrhaphy portion of the procedure also can have a significant negative impact on renal function3-5. It is possible to perform this procedure without clamping the hilum and also without formal renorrhaphy. However robust prospective formal evaluation of safety, risks, and potential benefits and whether or not the technique can be employed in a generalized fashion has not been studied. Demonstration of safety and generalizability may open a whole new avenue of approaching nephron sparing and renal function sparing kidney surgery and decrease potential risks for long term kidney disease in patients with renal masses. This study will investigate the safety, efficacy, and generalizability of the use of clampless, sutureless partial nephrectomy in the treatment of renal cell carcinoma.

Research Team

Padraic O'Malley, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Gasless laparoendoscopic single-port clampless sutureless partial nephrectomy for peripheral renal tumors: perioperative outcomes. [2015]

2. Australia pubmed.ncbi.nlm.nih.gov

Acute kidney injury and intermediate-term renal function after clampless partial nephrectomy. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Outcomes of gasless laparoendoscopic single-port partial nephrectomy in 356 consecutive patients: Feasibility of a clampless and sutureless technique. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Functional and oncological outcomes of 3D clampless sutureless laparoscopic partial nephrectomy for renal tumors with low nephrometry score. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Laparoscopic partial nephrectomy following tumor embolization in a hybrid room. Feasibility and clinical outcomes. [2018]

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

Comparison of Sutureless and Conventional Laparoscopic Partial Nephrectomy: A Propensity Score-Matching Analysis. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Partial nephrectomy for renal tumors using selective parenchymal clamping. [2018]