ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)

ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma (RCC)
• Intervention / Treatment: Procedure: sutureless, clampless partial nephrectomy

• Study Type: Interventional
• Enrollment (Estimated): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pravalika Manda; Phone Number: (352) 265-9728; Email: pmanda@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Principal Investigator: Padraic O'Malley
      • Contact: Pravalika Manda; Phone Number: 352-265-9728; Email: pmanda@ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clampless, sutureless robotic partial nephrectomy	Procedure: sutureless, clampless partial nephrectomy; All subjects will undergo a clampless, sutureless robotic partial nephrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive margin rate	Determine the positive margin rate, as measured on the pathology report 2-3 weeks post-surgery.	2-3 weeks post-surgery
Transfusion rate	Determine the transfusion rate, as measured approximately 4 weeks post-surgery via review of patient medical records.	4 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal dysfunction (1 day post-surgery)	Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 1-day post-surgery.	1 day post-surgery
Renal dysfunction (2-3 weeks post-surgery)	Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 2-3 weeks post-surgery.	2-3 weeks post-surgery
Renal dysfunction (6 months post-surgery)	Determine subject renal dysfunction, measured using estimated glomerular filtration rate using Cockcroft-gault formula, at 6 months post-surgery.	6 months post-surgery
Estimated blood loss	Determine the estimated blood loss, as determined on the operative report.	at time of partial nephrectomy
Need for ischemia	Determine how many subjects have a need for ischemia, as determined by need to clamp or not.	at time of partial nephrectomy

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Padraic O'Malley, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: kidney; partial nephrectomy; renal masses; renal hilar clamping; sutureless; clampless
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: UF-GU-011; IRB202500072 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No