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

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03259477
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Procedure: precise segmental renal arterial clamping; Procedure: laparoscopic partial nephrectomy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.Some participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental during laparoscopic partial nephrectomy and the others undergo complete renal arterial clamping.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.; Procedure: 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).
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; Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).

Outcome Measures

Primary Outcome Measures

1. Renal Functional Reserve change [3 month after surgery.]

   Change in renal functional reserve after laparoscopic partial nephrectomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital Capital Medical University	Beijing		China

Sponsors and Collaborators

• Xuanwu Hospital, Beijing

Investigators

• Study Chair: Tongwen Ou, MD., Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ou tongwen, chairman of urology, Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT03259477
• Other Study ID Numbers: otw-20170804-02
• First Posted: Aug 23, 2017
• Last Update Posted: Apr 29, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ou tongwen, chairman of urology, Xuanwu Hospital, Beijing: laparoscopic partial nephrectomy; precise segmental renal arterial clamping; renal cell carcinoma; renal functional reserve
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

No Results Posted as of Apr 29, 2020