Clinical trial NCT06722807: ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses
Official title: ClAmpless, Sutureless PartIAl Nephrectomy for Renal Masses (CASPIAN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma (RCC)
Keywords: partial nephrectomy
renal hilar clamping
renal masses
sutureless
clampless
kidney
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Positive margin rate
timeFrame: 2-3 weeks post-surgery
measure: Transfusion rate
timeFrame: 4 weeks post-surgery
Secondary outcomes:
measure: Renal dysfunction (1 day post-surgery)
timeFrame: 1 day post-surgery
measure: Renal dysfunction (2-3 weeks post-surgery)
timeFrame: 2-3 weeks post-surgery
measure: Renal dysfunction (6 months post-surgery)
timeFrame: 6 months post-surgery
measure: Estimated blood loss
timeFrame: at time of partial nephrectomy
measure: Need for ischemia
timeFrame: at time of partial nephrectomy
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Padraic O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References: