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

NCT ID: NCT03259477

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2021-10-31

Brief Summary

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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

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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

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Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Some participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental during laparoscopic partial nephrectomy and the others undergo complete renal arterial clamping.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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precise segmental clamping

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

Group Type EXPERIMENTAL

precise segmental renal arterial clamping

Intervention Type PROCEDURE

Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.

laparoscopic partial nephrectomy

Intervention Type PROCEDURE

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

complete clamping

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

Group Type ACTIVE_COMPARATOR

laparoscopic partial nephrectomy

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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ou tongwen

chairman of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tongwen Ou, MD.

Role: STUDY_CHAIR

Xuanwu Hospital, Beijing

Locations

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Xuanwu Hospital Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenhua Shang, MD.

Role: CONTACT

+8617801117318

Hao Yan

Role: CONTACT

+8683198448

Facility Contacts

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Zhenhua Shang

Role: primary

Other Identifiers

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otw-20170804-02

Identifier Type: -

Identifier Source: org_study_id

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