RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC

Capital Medical University

Status: Unknown

Conditions: Renal Cell Carcinoma

Treatments: Procedure: precise segmental renal arterial clamping; Procedure: laparoscopic partial nephrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03259477

otw-20170804-02

Details and patient eligibility

About

Renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC) undergoing laparoscopic partial nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.

Full description

Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).We hypothesized that renal functional reserve may be better in patients with clinical T1 renal cell carcinoma(RCC) undergoing laparoscopic partial(LPN) nephrectomy with precise segmental renal artery clamping than those with complete renal arterial clamping.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Age ≥18 2.Estimated GFR >30 mL/min/1.73m2 3.Anticipated intraoperative warm ischemic time ≤30 min 4.Subjects who signed informed consent forms

Exclusion criteria

1. Allergy to iothalamate, shellfish or iodine
2. Use of metformin or amiodarone
3. intraoperative warm ischemic time >30 min
4. Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
5. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
6. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
7. Inadequate intravenous access
8. Severe anemia (Hct <21%)
9. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
10. History of contrast-induced nephropathy
11. Hyperthyroidism
12. Pheochromocytoma
13. Sickle cell disease
14. Urinary retention or incontinence
15. Status post organ transplant
16. Pregnancy or active breast feeding
17. Cognitive impairment with inability to give consent
18. Institutionalized status

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

precise segmental clamping

Experimental group

Description:

These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.

Treatment:

Procedure: precise segmental renal arterial clamping

Procedure: laparoscopic partial nephrectomy

complete clamping

Active Comparator group

Description:

These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.

Treatment:

Procedure: laparoscopic partial nephrectomy