NCT03259477

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

August 21, 2017

Last Update Submit

April 27, 2020

Conditions

Renal Cell Carcinoma

Keywords

laparoscopic partial nephrectomyprecise segmental renal arterial clampingrenal cell carcinomarenal functional reserve

Outcome Measures

Primary Outcomes (1)

  • Renal Functional Reserve change

    Change in renal functional reserve after laparoscopic partial nephrectomy

    3 month after surgery.

Study Arms (2)

precise segmental clamping

EXPERIMENTAL

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

Procedure: precise segmental renal arterial clampingProcedure: 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.

Procedure: laparoscopic partial nephrectomy

Interventions

precise segmental renal arterial clampingPROCEDURE

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

precise segmental clamping
laparoscopic partial nephrectomyPROCEDURE

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

complete clampingprecise segmental clamping

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Tongwen Ou, MD.

    Xuanwu Hospital, Beijing

    STUDY CHAIR

Central Study Contacts

Zhenhua Shang, MD.

CONTACT

+8617801117318shangzhenhua16@126.com

Hao Yan

CONTACT

+8683198448outongwen1967@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Some participants with clinical T1 renal cell carcinoma(RCC) undergo precise segmental during laparoscopic partial nephrectomy and the others undergo complete renal arterial clamping.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chairman of urology

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 23, 2017

Study Start

February 1, 2018

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

CN(1)