Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01892059
• Other study ID #: ChiCTR-TRC-13003054
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2013
• Last updated: July 2, 2013
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2013
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Changjun Yin, MD, PHD
• Phone: +86 25-68136319
• Email: lee_lipu[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Department of Urology, First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	estimated blood loss		during surgery	Yes
Primary	Glomerular Filtration Rate		3 months postoperative	No
Secondary	warm ischemia time		during surgery	No