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

Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03259477
Enrollment
100
Registered
2017-08-23
Start date
2018-02-01
Completion date
2021-10-31
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

laparoscopic partial nephrectomy, precise segmental renal arterial clamping, renal cell carcinoma, renal functional reserve

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.

Interventions

PROCEDUREprecise segmental renal arterial clamping

Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.

Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Renal Functional Reserve change3 month after surgery.Change in renal functional reserve after laparoscopic partial nephrectomy

Countries

China

Contacts

Primary ContactZhenhua Shang, MD.
shangzhenhua16@126.com+8617801117318
Backup ContactHao Yan
outongwen1967@126.com+8683198448

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026