Clinical trial NCT03259477: RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC
Official title: Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: laparoscopic partial nephrectomy
precise segmental renal arterial clamping
renal cell carcinoma
renal functional reserve
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Some participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental during laparoscopic partial nephrectomy and the others undergo complete renal arterial clamping.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Renal Functional Reserve change
timeFrame: 3 month after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Tongwen Ou, MD.
role: STUDY_CHAIR
References: