Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Changjun Yin, MD, PHD
  • Phone Number: +86 25-68136319
  • Email: lee_lipu@163.com

Study Contact Backup

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Department of Urology, First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Changjun Yin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Segmental artery clamping
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.
Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.
Active Comparator: Main renal artery clamping
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.
Laparoscopic partial nephrectomy with main renal artery clamping technique will be performed for patients enrolled in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glomerular Filtration Rate
Time Frame: 3 months postoperative
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
warm ischemia time
Time Frame: during surgery
during surgery

Other Outcome Measures

Outcome Measure
Time Frame
estimated blood loss
Time Frame: during surgery
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Changjun Yin, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

June 30, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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