Stone, KidneyNCT03771365
Standard-PCNL vs Mini-PCNL vs Super-mini PCNL for the Treatment of ≥2 cm Renal Stone
An observational study of Stone, Kidney and Lithiasis Renal, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
Background: Standard-PCNL was considered as the first choice for ≥2 cm renal stones. Miniaturized technique Mini-PCNL has also been implicated in the past two decades. Recently, Super-mini PCNL (SMP) was introduced to treated ≤2.5cm renal stone. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Stone, Kidney, Lithiasis Renal, Surgery
- What is being tested?
- Standard-PCNL, Mini-PCNL and SMP
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jan 2022
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
Who may be able to join
- Patient ≥14 years old
- Patient is a candidate for Standard-PCNL, Mini-PCNL or SMP treatment of a renal stone
Who cannot join
- Patient <14 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An International Multi-center Prospective Cohort Study Comparing the Safety and Efficacy of Super-mini-PCNL, Mini-PCNL and Standard PCNL in the Treatment of ≥2cm Renal Stones
Background: Standard-PCNL was considered as the first choice for ≥2 cm renal stones. Miniaturized technique Mini-PCNL has also been implicated in the past two decades. Recently, Super-mini PCNL (SMP) was introduced to treated ≤2.5cm renal stone. The miniaturized techniques seemed to take a longer operating time and have risk of getting infectious complications. However, there is no high quality of evidence showing that which kind of PCNL is best or what kind of patients is suitable for standard-PCNL, mini-PCNL or SMP.
Objective: To compare the efficacy and safety of Standard-PCNL (≥24Fr), Mini-PCNL (12-20Fr) and SMP(10-14Fr) for the treatment of ≥2 cm renal stones Study design: This study is a prospective, observational, international, multicenter registry cohort study Study population: All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
Read the detailed description
BACKGROUND AND RATIONALE Percutaneous nephrolithotomy (PCNL) is the first-choice for the treatment of renal stone ≥20 mm with high stone free rate (SFR). However, there are some sever complications such as bleeding. Severe bleeding needs arterial embolization, which might impair the renal function. The size of percutaneous access tract has been proven to be closely related to the risk of bleeding complications. Mini-PCNL was firstly introduced by Jackman in 1998 to treat pediatric renal stone with the aim to lower the morbidity. Mini-PCNL was gradually applied to adults. In recent years, urologists were still attempting to reduce size of the sheath and modify the sheath. They aimed to reduce the risk of bleeding. The first generation SMP consists of a 10-14 F access sheath with a suction-evacuation function and a 7-F nephroscope with enhanced irrigation was introduced by Guohua Zeng's group in 2014. In 2016, Guohua Zeng's group continued to introduce a modified SMP technique and system. The most remarkable feature of the new generation super-mini percutaneous nephrolithotomy (New-SMP) was metal irrigation-suction sheath which made the new system have higher efficiency than the old one. With the modified SMP technique and system, SMP was performed to treat large renal stone. (≥2cm). Moreover, SMP with an irrigation-suction sheath obviously improved the efficiency of removing the fragments and lower the intrapelvic pressure.
Although miniaturized techniques decreased the bleeding-related morbidity and have a similar SFR, they seemed to take a longer operating time and have risk of getting infectious complications. However, till now, no high quality of evidence demonstrated that what size of tract is the best for the treatment of ≥2 cm renal stone. Perhaps the investigators should find out a subgroup suitable for standard-PCNL, Mini-PCNL or SMP respectively.
STUDY OBJECTIVES The aim of this registry is to review current clinical practice on PCNL for stone treatment. The investigators will explore the answers to the following questions: What kind of PCNL urologists prefers to used? Is there a best cutoff based on the size of stones to divide the patients into subgroups, or a scoring system to decide which kind of PCNL is the best choice for individuals? Primary Objective To compare the stone free rate (SFR) (%) among standard-PCNL, Mini-PCNL and SMP for the treatment of ≥2 cm renal stone.
Secondary Objectives
- Bleeding complication: hematocrit drop (g/L) and rate of transfusion (%).
- Infectious complication: rate of getting fever (≥38℃) (%) and urosepsis (%).
- Intraoperative indexes: operating time (mins), rate of tubeless/total tubeless (%).
- Postoperative indexes: hospital stay (mins), visual analogue scale (VAS) score (range from 0-10, the higher value represents the worse outcome) STUDY DESIGN This study is a prospective, observational, international, multicenter registry cohort study SELECTION AND ENROLLMENT OF PARTICIPANTS Clinical Recruitment All sites for this pilot study are recruited by IAU Members. Each participating center should obtain ethical approval, as needed, according to local regulations.
Each participating centre will include all consecutive eligible patients. PCNL procedures are performed according local protocols and surgeons' own propensity. Data will be collected in the IAU online platform (http://47.74.212.47/#/login), which is developed by IAU. Each participating center has own account and password to login and collect data. Data analysis will be coordinated by IAU.
Study Population All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
Surgical procedure The procedure of SMP, mini-PCNL and Standard-PCNL was according to surgeons' propensity, the related details were recorded online.
- Conditions
- Stone, Kidney, Lithiasis Renal, Surgery
- Being tested
- Standard-PCNL, Mini-PCNL, SMP
- Keywords
- percutaneous nephrostolithotomy, renal stone, safety, efficacy
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-PCNLProcedure or surgery
percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone
Mini-PCNLProcedure or surgery
percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone
SMPProcedure or surgery
percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone
| Study group | Role | What they receive |
|---|---|---|
| Standard-PCNL | Perform PCNL with ≥24 Fr access tract for the treatment of ≥2 renal stones Receives: Procedure: Standard-PCNL | |
| Mini-PCNL | Perform PCNL with 12-20 Fr access tract for the treatment of ≥2 renal stones Receives: Procedure: Mini-PCNL | |
| Super-mini PCNL | Perform SMP for the treatment of ≥2 renal stones Receives: Procedure: SMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate (SFR) (%)
Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
Measured: 1-3 months after the day of DJ stent/ureteral catheter removal or the day of operation (if no DJ stent or ureteral catheter placed postoperatively).
Secondary outcomes (1)
Perioperative complications
Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on
Measured: intraoperatively or ≤ 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stone, KidneyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria, Massachusetts General Hospital, Hospital de Clinicas José de San Martín, Goldstadt Private Clinic, University College London Hospitals, Hospital de Base do Distrito Federal, Mexican National Council of Urology, Vancouver General Hospital, Lions Kidney Hospital and Urology Institute, Mt. Carmel Diocesan General Hospital, Clinical Emergency County Hospital, University of Belgrade, University of Sao Paulo General Hospital, Vayodha and Venus International Hospitals, University Hospital of Vinalopo, Sismanoglio General Hospital, New Mowasat Hospital
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Guohua Zeng, PH.D & MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771365
- Sponsor's protocol ID
- 1stAHGZMU
- Status last verified
- Dec 2018
- First submitted
- 10 Nov 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is a international multi-center prospective cohort study, the data is not available to other researchers before the agreement from all the centers
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multi-center Prospective Cohort Study Comparing the Safety and Efficacy of Super-mini-PCNL, Mini-PCNL and Standard PCNL in the Treatment of ≥2cm Renal Stones
- ClinicalTrials.gov ID
- NCT03771365
- Acronym / sponsor ID
- 1stAHGZMU
- Conditions
- Stone, Kidney, Lithiasis Renal, Surgery
- Keywords
- percutaneous nephrostolithotomy, renal stone, safety, efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Military Medical Academy, Bulgaria, Massachusetts General Hospital, Hospital de Clinicas José de San Martín, Goldstadt Private Clinic, University College London Hospitals, Hospital de Base do Distrito Federal, Mexican National Council of Urology, Vancouver General Hospital, Lions Kidney Hospital and Urology Institute, Mt. Carmel Diocesan General Hospital, Clinical Emergency County Hospital, University of Belgrade, University of Sao Paulo General Hospital, Vayodha and Venus International Hospitals, University Hospital of Vinalopo, Sismanoglio General Hospital, New Mowasat Hospital
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 11 Dec 2018 (actual)
- 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.
Background: Standard-PCNL was considered as the first choice for ≥2 cm renal stones. Miniaturized technique Mini-PCNL has also been implicated in the past two decades. Recently, Super-mini PCNL (SMP) was introduced to treated ≤2.5cm renal stone. The miniaturized techniques seemed to take a longer operating time and have risk of getting infectious complications. However, there is no high quality of evidence showing that which kind of PCNL is best or what kind of patients is suitable for standard-PCNL, mini-PCNL or SMP.
Objective: To compare the efficacy and safety of Standard-PCNL (≥24Fr), Mini-PCNL (12-20Fr) and SMP(10-14Fr) for the treatment of ≥2 cm renal stones Study design: This study is a prospective, observational, international, multicenter registry cohort study Study population: All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
Detailed description
BACKGROUND AND RATIONALE Percutaneous nephrolithotomy (PCNL) is the first-choice for the treatment of renal stone ≥20 mm with high stone free rate (SFR). However, there are some sever complications such as bleeding. Severe bleeding needs arterial embolization, which might impair the renal function. The size of percutaneous access tract has been proven to be closely related to the risk of bleeding complications. Mini-PCNL was firstly introduced by Jackman in 1998 to treat pediatric renal stone with the aim to lower the morbidity. Mini-PCNL was gradually applied to adults. In recent years, urologists were still attempting to reduce size of the sheath and modify the sheath. They aimed to reduce the risk of bleeding. The first generation SMP consists of a 10-14 F access sheath with a suction-evacuation function and a 7-F nephroscope with enhanced irrigation was introduced by Guohua Zeng's group in 2014. In 2016, Guohua Zeng's group continued to introduce a modified SMP technique and system. The most remarkable feature of the new generation super-mini percutaneous nephrolithotomy (New-SMP) was metal irrigation-suction sheath which made the new system have higher efficiency than the old one. With the modified SMP technique and system, SMP was performed to treat large renal stone. (≥2cm). Moreover, SMP with an irrigation-suction sheath obviously improved the efficiency of removing the fragments and lower the intrapelvic pressure.
Although miniaturized techniques decreased the bleeding-related morbidity and have a similar SFR, they seemed to take a longer operating time and have risk of getting infectious complications. However, till now, no high quality of evidence demonstrated that what size of tract is the best for the treatment of ≥2 cm renal stone. Perhaps the investigators should find out a subgroup suitable for standard-PCNL, Mini-PCNL or SMP respectively.
STUDY OBJECTIVES The aim of this registry is to review current clinical practice on PCNL for stone treatment. The investigators will explore the answers to the following questions: What kind of PCNL urologists prefers to used? Is there a best cutoff based on the size of stones to divide the patients into subgroups, or a scoring system to decide which kind of PCNL is the best choice for individuals? Primary Objective To compare the stone free rate (SFR) (%) among standard-PCNL, Mini-PCNL and SMP for the treatment of ≥2 cm renal stone.
Secondary Objectives
- Bleeding complication: hematocrit drop (g/L) and rate of transfusion (%).
- Infectious complication: rate of getting fever (≥38℃) (%) and urosepsis (%).
- Intraoperative indexes: operating time (mins), rate of tubeless/total tubeless (%).
- Postoperative indexes: hospital stay (mins), visual analogue scale (VAS) score (range from 0-10, the higher value represents the worse outcome) STUDY DESIGN This study is a prospective, observational, international, multicenter registry cohort study SELECTION AND ENROLLMENT OF PARTICIPANTS Clinical Recruitment All sites for this pilot study are recruited by IAU Members. Each participating center should obtain ethical approval, as needed, according to local regulations.
Each participating centre will include all consecutive eligible patients. PCNL procedures are performed according local protocols and surgeons' own propensity. Data will be collected in the IAU online platform (http://47.74.212.47/#/login), which is developed by IAU. Each participating center has own account and password to login and collect data. Data analysis will be coordinated by IAU.
Study Population All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
Surgical procedure The procedure of SMP, mini-PCNL and Standard-PCNL was according to surgeons' propensity, the related details were recorded online.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard-PCNL | – | Procedure: Standard-PCNLPerform PCNL with ≥24 Fr access tract for the treatment of ≥2 renal stones |
| Mini-PCNL | – | Procedure: Mini-PCNLPerform PCNL with 12-20 Fr access tract for the treatment of ≥2 renal stones |
| Super-mini PCNL | – | Procedure: SMPPerform SMP for the treatment of ≥2 renal stones |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients ≥14 years with ≥2 cm renal stone who are planned for Standard-PCNL, Mini-PCNL or SMP are eligible for this study.
Key inclusion criteria (2 listed)
- Patient ≥14 years old
- Patient is a candidate for Standard-PCNL, Mini-PCNL or SMP treatment of a renal stone
Key exclusion criteria (1 listed)
- Patient <14 years old
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 |
|---|---|---|
| Standard-PCNLpercutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone | Procedure or surgery | Standard-PCNL |
| Mini-PCNLpercutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone | Procedure or surgery | Mini-PCNL |
| SMPpercutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone | Procedure or surgery | Super-mini PCNL |
Primary outcome
Stone free rate (SFR) (%)
Time frame: 1-3 months after the day of DJ stent/ureteral catheter removal or the day of operation (if no DJ stent or ureteral catheter placed postoperatively).
Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.
1 secondary outcome
Perioperative complications
Time frame: intraoperatively or ≤ 1 month postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: Undecided. It is a international multi-center prospective cohort study, the data is not available to other researchers before the agreement from all the centers
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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.
Guohua Zeng, PH.D & MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Stone, Kidney and Lithiasis Renal, run by The First Affiliated Hospital of Guangzhou Medical University.
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 1 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Guohua Zeng, PH.D & MD (+86 13802916676, gzgyzgh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (SFR) (%) (time frame: 1-3 months after the day of DJ stent/ureteral catheter removal or the day of operation (if no DJ stent or ureteral catheter placed postoperatively).). 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 11 Dec 2018.