Renal Cell CarcinomaNCT03259477
RFR Change of Precise Segmental Versus Complete Renal Arterial Clamping During LPN for Clinical T1 RCC
A study testing precise segmental renal arterial clamping and laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by Xuanwu Hospital, Beijing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- precise segmental renal arterial clamping and laparoscopic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Zhenhua Shang
About this study
Official title: Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma
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.
- Conditions
- Renal Cell Carcinoma
- Being tested
- precise segmental renal arterial clamping, laparoscopic partial nephrectomy
- Keywords
- laparoscopic partial nephrectomy, precise segmental renal arterial clamping, renal cell carcinoma, renal functional reserve
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
precise segmental renal arterial clampingProcedure or surgery
Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.
laparoscopic partial nephrectomyProcedure or surgery
Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
| Study group | Role | What they receive |
|---|---|---|
| precise segmental clamping | Experimental | These participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy. Receives: Procedure: precise segmental renal arterial clamping; Procedure: laparoscopic partial nephrectomy |
| complete clamping | Active comparator | These participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy. Receives: Procedure: laparoscopic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Functional Reserve change
Change in renal functional reserve after laparoscopic partial nephrectomy
Measured: 3 month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start1 Feb 2018
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ou tongwen, Xuanwu Hospital, Beijing
- Investigators
- Tongwen Ou, MD., Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259477
- Sponsor's protocol ID
- otw-20170804-02
- Status last verified
- Apr 2020
- First submitted
- 21 Aug 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Functional Reserve Change of Precise Segmental Versus Complete Renal Arterial Clamping During Laparoscopic Partial Nephrectomy for Clinical T1 Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03259477
- Acronym / sponsor ID
- otw-20170804-02
- Conditions
- Renal Cell Carcinoma
- Keywords
- laparoscopic partial nephrectomy, precise segmental renal arterial clamping, renal cell carcinoma, renal functional reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| precise segmental clamping | Experimental | Procedure: precise segmental renal arterial clamping, Procedure: laparoscopic partial nephrectomyThese participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental renal arterial clamping during laparoscopic partial nephrectomy. |
| complete clamping | Active comparator | Procedure: laparoscopic partial nephrectomyThese participants with clinical T1 renal cell carcinoma(RCC) undergo complete renal arterial clamping during laparoscopic partial nephrectomy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| precise segmental renal arterial clampingPrecise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries. | Procedure or surgery | precise segmental clamping |
| laparoscopic partial nephrectomyLaparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC). | Procedure or surgery | complete clamping, precise segmental clamping |
Primary outcome
Renal Functional Reserve change
Time frame: 3 month after surgery.
Change in renal functional reserve after laparoscopic partial nephrectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tongwen Ou, MD. study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing precise segmental renal arterial clamping and laparoscopic partial nephrectomy in people with Renal Cell Carcinoma, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenhua Shang, MD. (+8617801117318, shangzhenhua16@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Functional Reserve change (time frame: 3 month after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.