Sutureless and clampless surgery for kidney tumors

ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)

This study is testing a new surgery for kidney tumors that doesn't use clamps or stitches to see if it can help patients keep their kidney function while treating their cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 59 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (other)
• Locations: 1 site (Gainesville, Florida)
• Trial ID: NCT06722807 on ClinicalTrials.gov

What this trial studies

This study investigates a novel surgical technique for partial nephrectomy that eliminates the need for clamping the renal hilum and formal suturing. The goal is to minimize ischemia and preserve renal function while treating renal cell carcinoma. By evaluating the safety, efficacy, and generalizability of this approach, the study aims to determine if it can be widely adopted in clinical practice. The research will involve adult patients with renal masses of 7 cm or less undergoing this innovative surgical procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of renal cell carcinoma and renal masses measuring 7 cm or less.

Not a fit: Patients with multiple active malignancies or those with renal vein thrombus may not benefit from this study.

Why it matters

Potential benefit: If successful, this technique could lead to improved kidney function preservation and reduced long-term risks of kidney disease for patients undergoing surgery for renal masses.

How similar studies have performed: While similar approaches have been explored, this specific clampless and sutureless technique has not been formally evaluated in a robust prospective manner.

Eligibility criteria

Inclusion Criteria:

* Adults ≥ 18 years of age.
* Patients undergoing partial nephrectomy for renal masses ≤ 7 cm
* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the Principal Investigator\] may be included).
* A clinical diagnosis consistent with renal cell carcinoma, cT1-3 N0 M0 without renal vein thrombus.
* Adequate laboratory test results, including:

  1. Platelets \> 50,000/µL
  2. Hemoglobin \> 9.0 g/dL
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
* Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 2 weeks after surgery to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 2 weeks following surgery.

Exclusion Criteria:

* Bleeding disorder (any congenital bleeding diathesis)
* Liver dysfunction with end stage liver disease as determined by the treating investigator
* Presence of renal vein thrombus
* End stage renal disease (eGFR \< 15 using Cockcroft-gault formula or receiving renal replacement therapy (i.e. dialysis))
* Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 2 weeks after surgery.
* Subjects who are confirmed to be pregnant or breastfeeding.
* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Where this trial is running

Gainesville, Florida

• University of Florida — Gainesville, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Padraic O'Malley, MD — University of Florida
• Study coordinator: Pravalika Manda

Conditions: Renal Cell Carcinoma, partial nephrectomy, renal hilar clamping, renal masses, sutureless, clampless, kidney