RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC
Primary Purpose
Renal Cell Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
precise segmental renal arterial clamping
laparoscopic partial nephrectomy
Sponsored by
About this trial
This is an interventional prevention trial for Renal Cell Carcinoma focused on measuring laparoscopic partial nephrectomy, precise segmental renal arterial clamping, renal cell carcinoma, renal functional reserve
Eligibility Criteria
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:
- Allergy to iothalamate, shellfish or iodine
- Use of metformin or amiodarone
- intraoperative warm ischemic time >30 min
- 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)
- Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- Inadequate intravenous access
- Severe anemia (Hct <21%)
- 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)
- History of contrast-induced nephropathy
- Hyperthyroidism
- Pheochromocytoma
- Sickle cell disease
- Urinary retention or incontinence
- Status post organ transplant
- Pregnancy or active breast feeding
- Cognitive impairment with inability to give consent
- Institutionalized status
Sites / Locations
- Xuanwu Hospital Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
precise segmental clamping
complete clamping
Arm Description
These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.
These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.
Outcomes
Primary Outcome Measures
Renal Functional Reserve change
Change in renal functional reserve after laparoscopic partial nephrectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT03259477
First Posted
August 21, 2017
Last Updated
April 27, 2020
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT03259477
Brief Title
RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC
Official Title
Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
laparoscopic partial nephrectomy, precise segmental renal arterial clamping, renal cell carcinoma, renal functional reserve
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
precise segmental clamping
Arm Type
Experimental
Arm Description
These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy.
Arm Title
complete clamping
Arm Type
Active Comparator
Arm Description
These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
precise segmental renal arterial clamping
Intervention Description
Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic partial nephrectomy
Intervention Description
Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
Primary Outcome Measure Information:
Title
Renal Functional Reserve change
Description
Change in renal functional reserve after laparoscopic partial nephrectomy
Time Frame
3 month after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Allergy to iothalamate, shellfish or iodine
Use of metformin or amiodarone
intraoperative warm ischemic time >30 min
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)
Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
Inadequate intravenous access
Severe anemia (Hct <21%)
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)
History of contrast-induced nephropathy
Hyperthyroidism
Pheochromocytoma
Sickle cell disease
Urinary retention or incontinence
Status post organ transplant
Pregnancy or active breast feeding
Cognitive impairment with inability to give consent
Institutionalized status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenhua Shang, MD.
Phone
+8617801117318
Email
shangzhenhua16@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Yan
Phone
+8683198448
Email
outongwen1967@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tongwen Ou, MD.
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenhua Shang
12. IPD Sharing Statement
Learn more about this trial
RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC
We'll reach out to this number within 24 hrs