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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259477
• Other study ID #: otw-20170804-02
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 2021

Study information

• Verified date: April 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Zhenhua Shang, MD.
• Phone: +8617801117318
• Email: shangzhenhua16[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Functional Reserve change	Change in renal functional reserve after laparoscopic partial nephrectomy	3 month after surgery.