Clinical trial NCT01892059: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Neoplasms
Renal Cell Carcinoma
Keywords: renal tumour
partial nephrectomy
laparoscope
segmental renal artery clamping
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glomerular Filtration Rate
timeFrame: 3 months postoperative
Secondary outcomes:
measure: warm ischemia time
timeFrame: during surgery
Other outcomes:
measure: estimated blood loss
timeFrame: during surgery
Locations:
city: Nanjing
country: China
facility: Department of Urology, First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Changjun Yin
role: STUDY_DIRECTOR
References:
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.
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.
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.