RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC
NCT ID: NCT03259477
Last Updated: 2020-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-02-01
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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precise segmental clamping
These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.
precise 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
Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
complete clamping
These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.
laparoscopic partial nephrectomy
Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
Interventions
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precise 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
Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
90 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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ou tongwen
chairman of urology
Principal Investigators
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Tongwen Ou, MD.
Role: STUDY_CHAIR
Xuanwu Hospital, Beijing
Locations
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Xuanwu Hospital Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Zhenhua Shang
Role: primary
Other Identifiers
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otw-20170804-02
Identifier Type: -
Identifier Source: org_study_id
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