the Patients With Partial NephrectomyNCT01891032
Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery
An observational study of the Patients With Partial Nephrectomy, run by Yonsei University at 1 site in South Korea.
Trial summary
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- the Patients With Partial Nephrectomy
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to May 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. the adult patients with open partial nephrectomy 2. the adult patients with laparoscopic partial nephrectomy 3. the adult patients with VAMS partial nephrectomy, 4: the adult patients with robotic partial nephrectomy
Who may be able to join
- adults patient more than 20 years old with ASA score 1-3
- the patients who undergoing partial nephrectomy for the renal mass less than 7 cm
Who cannot join
- the patient with previous history with renal surgery
- the patient with bilateral partial nephrectomy
- the patient with synchronous operation for other intraperitoneal surgery
- the renal mass more than 7 cm
- previous kinds of surgery is changed into other kinds due to bleeding, etc
- the patient with serum Cr level more than 1.4 mg/dl
- the patient who does not understand the consent form
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Urological Science Institute, Yonsei University, Colleage of Medicine
Seoul, Seoul, 120-752
About this study
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.
- Conditions
- the Patients With Partial Nephrectomy
- Keywords
- acute kidney injury, partial nephrectomy, biomarker
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the patients with open partial nephrectomy | the adult patients with open partial nephrectomy | |
| laparoscopic | the adult patients with laparoscopic partial nephrectomy | |
| VAMS | the adult patients with VAMS partial nephrectomy | |
| robotic | the adult patients with robotic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of urinary NGAL
Analysis of correlation between the level of preoperative and postoperative urinary NGAL
Measured: changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Patients With Partial NephrectomyStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891032
- Sponsor's protocol ID
- 4-2013-0261
- Status last verified
- Jul 2014
- First submitted
- 27 Jun 2013
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01891032
- Acronym / sponsor ID
- 4-2013-0261
- Conditions
- the Patients With Partial Nephrectomy
- Keywords
- acute kidney injury, partial nephrectomy, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 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.
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| the patients with open partial nephrectomy | – | –the adult patients with open partial nephrectomy |
| laparoscopic | – | –the adult patients with laparoscopic partial nephrectomy |
| VAMS | – | –the adult patients with VAMS partial nephrectomy |
| robotic | – | –the adult patients with robotic partial nephrectomy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. the adult patients with open partial nephrectomy 2. the adult patients with laparoscopic partial nephrectomy 3. the adult patients with VAMS partial nephrectomy, 4: the adult patients with robotic partial nephrectomy
Key inclusion criteria (2 listed)
- adults patient more than 20 years old with ASA score 1-3
- the patients who undergoing partial nephrectomy for the renal mass less than 7 cm
Key exclusion criteria (7 listed)
- the patient with previous history with renal surgery
- the patient with bilateral partial nephrectomy
- the patient with synchronous operation for other intraperitoneal surgery
- the renal mass more than 7 cm
- previous kinds of surgery is changed into other kinds due to bleeding, etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The level of urinary NGAL
Time frame: changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy
Analysis of correlation between the level of preoperative and postoperative urinary NGAL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Patients With Partial Nephrectomy, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 28 Jul 2014. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of urinary NGAL (time frame: changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2014.