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Status unknownNCT03259477Updated Apr 29, 2020

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

An interventional study of precise segmental renal arterial clamping and laparoscopic partial nephrectomy in Renal Cell Carcinoma, sponsored by Xuanwu Hospital, Beijing. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Cell Carcinoma

Keywords

  • laparoscopic partial nephrectomy
  • precise segmental renal arterial clamping
  • renal cell carcinoma
  • renal functional reserve
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    precise segmental clamping

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

    Procedure: precise segmental renal arterial clamping · Procedure: laparoscopic partial nephrectomy

  • Active comparator
    complete clamping

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

    Procedure: laparoscopic partial nephrectomy

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.

  • Procedurelaparoscopic partial nephrectomy

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

05

What researchers measure

Primary outcomes

  1. Renal Functional Reserve change

    Change in renal functional reserve after laparoscopic partial nephrectomy

    Time frame: 3 month after surgery.

06

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital Capital Medical University
    Beijing, China
    • Zhenhua Shang · Contact
    Recruiting
07

Registry details

Key details

Study ID
NCT03259477
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
ou tongwen (chairman of urology, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Aug 23, 2017
Start date
Feb 1, 2018
Primary completion
Sep 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Apr 29, 2020

Study contacts

Zhenhua Shang, MD.
Contact
shangzhenhua16@126.com
+8617801117318
Hao Yan
Contact
outongwen1967@126.com
+8683198448
Tongwen Ou, MD.
study chair · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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