NCT01892059

Brief Summary

The purpose of this study is to compare the efficacy and safety of the segmental artery clamping and main renal artery clamping during laparoscopic partial nephrectomy

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 May 2013

Typical duration 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

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 3, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 30, 2013

Last Update Submit

July 2, 2013

Conditions

Kidney NeoplasmsRenal Cell Carcinoma

Keywords

renal tumourpartial nephrectomylaparoscopesegmental renal artery clamping

Outcome Measures

Primary Outcomes (1)

  • Glomerular Filtration Rate

    3 months postoperative

Secondary Outcomes (1)

  • warm ischemia time

    during surgery

Other Outcomes (1)

  • estimated blood loss

    during surgery

Study Arms (2)

Segmental artery clamping

EXPERIMENTAL

Patients with Renal tumor are randomized into this group,they will received laparoscopic partial nephrectomy. During operation, the technique of segmental renal artery clamping will performed.

Procedure: Segmental artery clamping

Main renal artery clamping

ACTIVE COMPARATOR

Patients with renal tumor are randomized into this group,they will received laparoscopic partial nephrectomy. During operation, the technique of traditional main renal artery clamping will be performed.

Procedure: Main renal artery clamping

Interventions

Segmental artery clampingPROCEDURE

Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.

Segmental artery clamping
Main renal artery clampingPROCEDURE

Laparoscopic partial nephrectomy with main renal artery clamping technique will be performed for patients enrolled in this group.

Main renal artery clamping

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<age\<70yr
  • Stage T1a
  • Patients volunteered for this study and provided written informed consent

You may not qualify if:

  • Bilateral renal tumor
  • tumor of solitary kidney
  • glomerulonephritis
  • renal insufficiency
  • GFR of invalid kidney less than 30ml/min
  • presence of suspect metastasis
  • serious systematic disease: severe coagulation disorders
  • important organ insufficiency and severe psychological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (3)

  • Shao P, Tang L, Li P, Xu Y, Qin C, Cao Q, Ju X, Meng X, Lv Q, Li J, Zhang W, Yin C. Precise segmental renal artery clamping under the guidance of dual-source computed tomography angiography during laparoscopic partial nephrectomy. Eur Urol. 2012 Dec;62(6):1001-8. doi: 10.1016/j.eururo.2012.05.056. Epub 2012 Jun 7.

    PMID: 22695243BACKGROUND

  • Shao P, Tang L, Li P, Xu Y, Qin C, Cao Q, Ju X, Meng X, Lv Q, Li J, Zhang W, Yin C. Application of a vasculature model and standardization of the renal hilar approach in laparoscopic partial nephrectomy for precise segmental artery clamping. Eur Urol. 2013 Jun;63(6):1072-81. doi: 10.1016/j.eururo.2012.10.017. Epub 2012 Oct 24.

    PMID: 23116655BACKGROUND

  • Shao P, Qin C, Yin C, Meng X, Ju X, Li J, Lv Q, Zhang W, Xu Z. Laparoscopic partial nephrectomy with segmental renal artery clamping: technique and clinical outcomes. Eur Urol. 2011 May;59(5):849-55. doi: 10.1016/j.eururo.2010.11.037. Epub 2010 Dec 7.

    PMID: 21146917RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Changjun Yin

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Changjun Yin, MD, PHD

CONTACT

+86 25-68136319lee_lipu@163.com

Pengfei Shao, MD, PHD

CONTACT

+86 25-68136851spf032@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Urology Department

Study Record Dates

First Submitted

June 30, 2013

First Posted

July 3, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

July 3, 2013

Record last verified: 2013-06

Locations

CN(1)