Back to results

Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

Primary Purpose

Kidney Neoplasms, Renal Cell Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Segmental artery clamping

Main renal artery clamping

About this trial

This is an interventional treatment trial for Kidney Neoplasms focused on measuring renal tumour, partial nephrectomy, laparoscope, segmental renal artery clamping

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Urology, First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Segmental artery clamping

Main renal artery clamping

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glomerular Filtration Rate

Secondary Outcome Measures

warm ischemia time

Full Information

NCT ID

NCT01892059

First Posted

June 30, 2013

Last Updated

July 2, 2013

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01892059

Brief Title

Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

Official Title

A Randomized Controlled Trial Comparing the Segmental Artery Clamping and Main Renal Artery Clamping During Laparoscopic Partial Nephrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed Description

Renal tumor patients,for whom laparoscopic partial nephrectomy is suitable, will be randomly divided into two groups,segmental artery clamping group and main artery clamping group. All procedures were performed by the same laparoscopic surgeon. Blood loss, operation time, warm ischemia time, complications and affected renal function before and after operation will be recorded and compared. The safety and efficiency of laparoscopic partial nephrectomy with segmental renal artery clamping will be evaluated in comparison with the conventional main renal artery clamping technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Neoplasms, Renal Cell Carcinoma

Keywords

renal tumour, partial nephrectomy, laparoscope, segmental renal artery clamping

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Segmental artery clamping

Arm Type

Experimental

Arm Description

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.

Arm Title

Main renal artery clamping

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Segmental artery clamping

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Main renal artery clamping

Intervention Description

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

Primary Outcome Measure Information:

Title

Glomerular Filtration Rate

Time Frame

3 months postoperative

Secondary Outcome Measure Information:

Title

warm ischemia time

Time Frame

during surgery

Other Pre-specified Outcome Measures:

Title

estimated blood loss

Time Frame

during surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 20<age<70yr Stage T1a Patients volunteered for this study and provided written informed consent Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changjun Yin, MD, PHD

Phone

+86 25-68136319

lee_lipu@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pengfei Shao, MD, PHD

Phone

+86 25-68136851

spf032@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changjun Yin

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Urology, First Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pu Li

Phone

+25 68136875

lee_lipu@163.com

First Name & Middle Initial & Last Name & Degree

Changjun Yin

12. IPD Sharing Statement

Citations:

PubMed Identifier

22695243

Citation

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.

Results Reference

background

PubMed Identifier

23116655

Citation

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.

Results Reference

background

PubMed Identifier

21146917

Citation

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.

Results Reference

result

Learn more about this trial

Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

We'll reach out to this number within 24 hrs