Kidney NeoplasmsNCT01892059
Study of Segmental Renal Artery Clamping During Laparoscopic Partial Nephrectomy
A study testing Segmental artery clamping and Main renal artery clamping in people with Kidney Neoplasms and Renal Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Neoplasms, Renal Cell Carcinoma
- What is being tested?
- Segmental artery clamping and Main renal artery clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20<age<70yr
- Stage T1a
- Patients volunteered for this study and provided written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Urology, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Pu Li, +25 68136875, lee_lipu@163.com
Changjun Yin
About this study
Official title: 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
Read the 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.
- Conditions
- Kidney Neoplasms, Renal Cell Carcinoma
- Being tested
- Segmental artery clamping, Main renal artery clamping
- Keywords
- renal tumour, partial nephrectomy, laparoscope, segmental renal artery clamping
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental artery clampingProcedure or surgery
Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.
Main renal artery clampingProcedure or surgery
Laparoscopic partial nephrectomy with main renal artery clamping technique will be performed for patients enrolled in this group.
| Study group | Role | What they receive |
|---|---|---|
| Segmental artery clamping | Experimental | 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. Receives: Procedure: Segmental artery clamping |
| Main renal artery clamping | Active comparator | 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. Receives: Procedure: Main renal artery clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular Filtration Rate
Measured: 3 months postoperative
Secondary outcomes (1)
warm ischemia time
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changjun Yin, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Changjun Yin, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892059
- Sponsor's protocol ID
- ChiCTR-TRC-13003054
- Status last verified
- Jun 2013
- First submitted
- 30 Jun 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22695243Shao 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.
PubMed 23116655Shao 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.
PubMed 21146917
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Segmental Artery Clamping and Main Renal Artery Clamping During Laparoscopic Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT01892059
- Acronym / sponsor ID
- ChiCTR-TRC-13003054
- Conditions
- Kidney Neoplasms, Renal Cell Carcinoma
- Keywords
- renal tumour, partial nephrectomy, laparoscope, segmental renal artery clamping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 3 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental artery clamping | Experimental | Procedure: Segmental artery clampingPatients 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. |
| Main renal artery clamping | Active comparator | Procedure: Main renal artery clampingPatients 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20<age<70yr
- Stage T1a
- Patients volunteered for this study and provided written informed consent
Key exclusion criteria (8 listed)
- Bilateral renal tumor
- tumor of solitary kidney
- glomerulonephritis
- renal insufficiency
- GFR of invalid kidney less than 30ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Segmental artery clampingLaparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group. | Procedure or surgery | Segmental artery clamping |
| Main renal artery clampingLaparoscopic partial nephrectomy with main renal artery clamping technique will be performed for patients enrolled in this group. | Procedure or surgery | Main renal artery clamping |
Primary outcome
Glomerular Filtration Rate
Time frame: 3 months postoperative
1 secondary outcome
warm ischemia time
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Background: PubMed 22695243Shao 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.
- Background: PubMed 23116655Shao 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.
- Results publication: PubMed 21146917Shao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changjun Yin study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmental artery clamping and Main renal artery clamping in people with Kidney Neoplasms and Renal Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changjun Yin, MD, PHD (+86 25-68136319, lee_lipu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular Filtration Rate (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892059, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.