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Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

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ClinicalTrials.gov Identifier: NCT01892059
Recruitment Status : Unknown
Verified June 2013 by Changjun Yin, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Changjun Yin, The First Affiliated Hospital with Nanjing Medical University

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

Condition or disease Intervention/treatment Phase
Kidney Neoplasms Renal Cell Carcinoma Procedure: Segmental artery clamping Procedure: Main renal artery clamping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Segmental Artery Clamping and Main Renal Artery Clamping During Laparoscopic Partial Nephrectomy
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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




Primary Outcome Measures :
  1. Glomerular Filtration Rate [ Time Frame: 3 months postoperative ]

Secondary Outcome Measures :
  1. warm ischemia time [ Time Frame: during surgery ]

Other Outcome Measures:
  1. estimated blood loss [ Time Frame: during surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892059


Contacts
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Contact: Changjun Yin, MD, PHD +86 25-68136319 lee_lipu@163.com
Contact: Pengfei Shao, MD, PHD +86 25-68136851 spf032@hotmail.com

Locations
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China, Jiangsu
Department of Urology, First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Pu Li    +25 68136875    lee_lipu@163.com   
Principal Investigator: Changjun Yin         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Director: Changjun Yin The First Affiliated Hospital with Nanjing Medical University

Publications of Results:
Other Publications:
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Responsible Party: Changjun Yin, Head of Urology Department, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01892059     History of Changes
Other Study ID Numbers: ChiCTR-TRC-13003054
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: June 2013
Keywords provided by Changjun Yin, The First Affiliated Hospital with Nanjing Medical University:
renal tumour
partial nephrectomy
laparoscope
segmental renal artery clamping
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases