Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy

NCT ID: NCT01892059

Last Updated: 2013-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Kidney Neoplasms Renal Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Segmental artery clamping

Intervention Type PROCEDURE

Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.

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.

Group Type ACTIVE_COMPARATOR

Main renal artery clamping

Intervention Type PROCEDURE

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

Interventions

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Segmental artery clamping

Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.

Intervention Type PROCEDURE

Main renal artery clamping

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Changjun Yin

Head of Urology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Changjun Yin

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Department of Urology, First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Changjun Yin, MD, PHD

Role: CONTACT

+86 25-68136319

Pengfei Shao, MD, PHD

Role: CONTACT

+86 25-68136851

Facility Contacts

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Pu Li

Role: primary

+25 68136875

References

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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.

Reference Type BACKGROUND
PMID: 22695243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23116655 (View on PubMed)

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.

Reference Type RESULT
PMID: 21146917 (View on PubMed)

Other Identifiers

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ChiCTR-TRC-13003054

Identifier Type: -

Identifier Source: org_study_id

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