- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892059
Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy
July 2, 2013 updated by: Changjun Yin, The First Affiliated Hospital with Nanjing Medical University
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Pengfei Shao, MD, PHD
- Phone Number: +86 25-68136851
- Email: spf032@hotmail.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- Department of Urology, First Affiliated Hospital of Nanjing Medical University
-
Contact:
- Pu Li
- Phone Number: +25 68136875
- Email: lee_lipu@163.com
-
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.
General Publications
- 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.
- 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.
- 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.
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChiCTR-TRC-13003054
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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