Stone, KidneyNCT05460559
Endoscopic Combined Intrarenal Surgery Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones:
A study testing Group A (p-PCNL) procedure and Group B (s-ECIRS) procedure in people with Stone, Kidney, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to compare outcomes of endoscopic combined intrarenal surgery (ECIRS) with the multi-tract percutaneous nephrolithotomy for management of complex renal stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stone, Kidney
- What is being tested?
- Group A (p-PCNL) procedure and Group B (s-ECIRS) procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age ≥ 18 years.
- Patients who are diagnosed as complex renal calculi (Guy's Stone Score (GSS) 3 or 4) as detected by Non-contrast Computed Tomography (NCCT).
Who cannot join
- Renal anatomic anomalies.
- Solitary kidney.
- Coagulation disorders.
- Skeletal deformity.
- Active urinary tract infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Urology and Nephrology Center
Al Mansurah, Outside U.S./Canada, 35516
Amr A Elsawy, 01009428750, amrelsawy.unc@hotmail.com
Ahmed El-Nahas, 00202202222, ar_el_nahas@yahoo.com
About this study
Official title: Endoscopic Combined Intrarenal Surgery Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Randomized Controlled Trial
The aim of this study is to compare outcomes of endoscopic combined intrarenal surgery (ECIRS) with the multi-tract percutaneous nephrolithotomy for management of complex renal stones.
Read the detailed description
Nephrolithiasis is a very common disease and continues to be a common cause of morbidity. The evolving epidemiology of this disease includes changes in gender distribution and associations with systemic disease. The currently available modalities for the treatment of renal calculi include extracorporeal shockwaves lithotripsy (SWL), flexible ureteroscopy (FURS) and percutaneous nephrolithotomy (PCNL).
Complex renal stones usually refer to multiple stones, stones associated with anatomical or functional abnormalities or staghorn calculi. They can cause severe morbidities such as renal failure, sepsis, and even death. Rassweiler et al. defined complex renal calculi based on stone burden and distribution, renal function and associated infection. Due to the complicated etiological factors, large stone burdens, high operation risks and high recurrence, it is always a challenge for surgeons to treat such stones. Complete stone clearance is the ultimate goal in staghorn calculi management because of the high incidence of recurrence and its inherent risks to the kidney and life of the patient.
Various management options are available for management of staghorn renal calculi including PCNL monotherapy, single-tract PCNL with flexible nephroscopy, multi-tract PCNL, combinations of PCNL and SWL, SWL monotherapy and open surgical options.
The American Urological Association (AUA) guidelines recommend PCNL as the first-line treatment for staghorn calculi. According to the European Association of Urology (EAU) guidelines, SWL remains the method of choice for the removal of stones within the renal pelvis, upper or middle calices measuring < 2 cm while larger stones (more than 2 cm) and lower pole stones more than 1.5 cm should be managed using PCNL.
It is noteworthy that prone position is conventionally used for PCNL surgical procedure, which facilitates percutaneous renal puncture and decreases the chance of splanchnic injury. However, it confines the application of Endoscopic Combined Intra-Renal Surgery (ECIRS). Scoffone CM et al. reported the use of ECIRS in Galdakao-Modified Supine Valdivia (GMSV) position for complex urolithiasis, the results showed that ECIRS in GMSV position generated high one step SFR, without additional procedure related complications.
As stone size increases, longer operative time, larger volume of irrigating fluid and multiple tracts may be required to achieve complete stone clearance as it is very difficult to access all the calices through a single percutaneous tract. Multiple access tracts are needed in as many as 20% to 58% of PCNL procedures.In case of complex calculi, the number of accesses is defined by the overall size, volume of the stone, anatomy of the pelvi-calyceal system (PCS), stone distribution, general health of the patient and the experience of the operating surgeon. So, multi-tract PCNL has been well established in the management of complex renal calculi. El-Nahas AR et al. reported that with PCNL monotherapy, the stone free rate (SFR) for staghorn calculi was 56%.Multiple tracts or multiple sessions of PCNL were required to get high SFR in patients with staghorn calculi while the tract related complications increased accordingly such as extravasation, bleeding, need for transfusion, infection, fever and deterioration in renal function. Indeed, several investigators have reported greater blood loss with more than one access tract.
On the other hand, many evidences have demonstrated that FURS is effective and safe for the renal stone less than 2 cm. Recently it is used to treat relatively large size intrarenal calculi . A meta-analysis published in 2012 showed that FURS can successfully treat patients with renal stones > 2 cm with satisfactory clinical outcome. However, flexible ureteroscopic lithotripsy is not recommended as monotherapy for staghorn calculi, while an important ancillary therapeutic option for residual stones following PCNL.
So, we need a new treatment modality to minimize the morbidity of multi-tract PCNL by evaluation of the ECIRS.
- Conditions
- Stone, Kidney
- Being tested
- Group A (p-PCNL) procedure, Group B (s-ECIRS) procedure
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (p-PCNL) procedureProcedure or surgery
In lithotomy position, ureteric catheter will be inserted allowing injection of contrast to obtain a pyelogram. Shifting the patients in prone position will be done. Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out. Amplatz sheath will be inserted to allow nephroscope to enter the collecting system. Stone disintegration will be performed using pneumatic, ultrasonic or laser lithotripsy. Eventually after removal of all stone fragments, a nephrostomy tube will be placed.
Group B (s-ECIRS) procedureProcedure or surgery
The patients will be in Galdakao-Modified Supine Valdivia (GMSV) position . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out till 30 Fr. Amplatz sheath will be inserted to allow a 26 Fr nephroscope to enter the collecting system. Retrograde intrarenal surgery will be applied simultaneously by a second surgeon using flexible ureteroscopy. The stones will be fragmented with holmium-yttrium-aluminum-garnet (YAG) laser and stone fragments will be evacuated by basket or removed through PCNL tract under nephroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Group A (p-PCNL) procedure | Active comparator | In lithotomy position, . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out. Amplatz sheath will be inserted to allow nephroscope to enter the collecting system. Stone disintegration will be performed using pneumatic, ultrasonic or laser lithotripsy. Eventually after removal of all stone fragments, a nephrostomy tube will be placed. Receives: Procedure: Group A (p-PCNL) procedure |
| Group B (s-ECIRS) procedure | Experimental | The patients will be in Galdakao-Modified Supine Valdivia (GMSV) position . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out till 30 Fr. Amplatz sheath will be inserted to allow a 26 Fr nephroscope to enter the collecting system. Retrograde intrarenal surgery will be applied simultaneously by a second surgeon using flexible ureteroscopy. The stones will be fragmented with holmium-yttrium-aluminum-garnet (YAG) laser and stone fragments will be evacuated by basket or removed through PCNL tract under nephroscopy. Receives: Procedure: Group B (s-ECIRS) procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
One stage stone free rate
It will include the one-stage SFR which is defined as the number of patients who will show no residual stones or only residual stone fragments < 4 mm in diameter at postoperative day-1 assessment NCCT
Measured: first post-operative day
Secondary outcomes (2)
Number of percutaneous access tracts required.
Number of percutaneous access tracts required.
Measured: during the procedure
Postoperative complications
Postoperative complications (Type, rate and using modified Dindo-Clavian grading system).
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Mar 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (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.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdel-Lateif El-Sawy, Mansoura University
- Investigators
- Ahmed A El-Nahas, Study director, Mansoura UniversityAhmed A Elshal, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460559
- Sponsor's protocol ID
- AS-7-2022
- Status last verified
- Nov 2022
- First submitted
- 13 Jul 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Combined Intrarenal Surgery Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05460559
- Acronym / sponsor ID
- AS-7-2022
- Conditions
- Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 15 Jul 2022 (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.
The aim of this study is to compare outcomes of endoscopic combined intrarenal surgery (ECIRS) with the multi-tract percutaneous nephrolithotomy for management of complex renal stones.
Detailed description
Nephrolithiasis is a very common disease and continues to be a common cause of morbidity. The evolving epidemiology of this disease includes changes in gender distribution and associations with systemic disease. The currently available modalities for the treatment of renal calculi include extracorporeal shockwaves lithotripsy (SWL), flexible ureteroscopy (FURS) and percutaneous nephrolithotomy (PCNL).
Complex renal stones usually refer to multiple stones, stones associated with anatomical or functional abnormalities or staghorn calculi. They can cause severe morbidities such as renal failure, sepsis, and even death. Rassweiler et al. defined complex renal calculi based on stone burden and distribution, renal function and associated infection. Due to the complicated etiological factors, large stone burdens, high operation risks and high recurrence, it is always a challenge for surgeons to treat such stones. Complete stone clearance is the ultimate goal in staghorn calculi management because of the high incidence of recurrence and its inherent risks to the kidney and life of the patient.
Various management options are available for management of staghorn renal calculi including PCNL monotherapy, single-tract PCNL with flexible nephroscopy, multi-tract PCNL, combinations of PCNL and SWL, SWL monotherapy and open surgical options.
The American Urological Association (AUA) guidelines recommend PCNL as the first-line treatment for staghorn calculi. According to the European Association of Urology (EAU) guidelines, SWL remains the method of choice for the removal of stones within the renal pelvis, upper or middle calices measuring < 2 cm while larger stones (more than 2 cm) and lower pole stones more than 1.5 cm should be managed using PCNL.
It is noteworthy that prone position is conventionally used for PCNL surgical procedure, which facilitates percutaneous renal puncture and decreases the chance of splanchnic injury. However, it confines the application of Endoscopic Combined Intra-Renal Surgery (ECIRS). Scoffone CM et al. reported the use of ECIRS in Galdakao-Modified Supine Valdivia (GMSV) position for complex urolithiasis, the results showed that ECIRS in GMSV position generated high one step SFR, without additional procedure related complications.
As stone size increases, longer operative time, larger volume of irrigating fluid and multiple tracts may be required to achieve complete stone clearance as it is very difficult to access all the calices through a single percutaneous tract. Multiple access tracts are needed in as many as 20% to 58% of PCNL procedures.In case of complex calculi, the number of accesses is defined by the overall size, volume of the stone, anatomy of the pelvi-calyceal system (PCS), stone distribution, general health of the patient and the experience of the operating surgeon. So, multi-tract PCNL has been well established in the management of complex renal calculi. El-Nahas AR et al. reported that with PCNL monotherapy, the stone free rate (SFR) for staghorn calculi was 56%.Multiple tracts or multiple sessions of PCNL were required to get high SFR in patients with staghorn calculi while the tract related complications increased accordingly such as extravasation, bleeding, need for transfusion, infection, fever and deterioration in renal function. Indeed, several investigators have reported greater blood loss with more than one access tract.
On the other hand, many evidences have demonstrated that FURS is effective and safe for the renal stone less than 2 cm. Recently it is used to treat relatively large size intrarenal calculi . A meta-analysis published in 2012 showed that FURS can successfully treat patients with renal stones > 2 cm with satisfactory clinical outcome. However, flexible ureteroscopic lithotripsy is not recommended as monotherapy for staghorn calculi, while an important ancillary therapeutic option for residual stones following PCNL.
So, we need a new treatment modality to minimize the morbidity of multi-tract PCNL by evaluation of the ECIRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (p-PCNL) procedure | Active comparator | Procedure: Group A (p-PCNL) procedureIn lithotomy position, . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out. Amplatz sheath will be inserted to allow nephroscope to enter the collecting system. Stone disintegration will be performed using pneumatic, ultrasonic or laser lithotripsy. Eventually after removal of all stone fragments, a nephrostomy tube will be placed. |
| Group B (s-ECIRS) procedure | Experimental | Procedure: Group B (s-ECIRS) procedureThe patients will be in Galdakao-Modified Supine Valdivia (GMSV) position . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out till 30 Fr. Amplatz sheath will be inserted to allow a 26 Fr nephroscope to enter the collecting system. Retrograde intrarenal surgery will be applied simultaneously by a second surgeon using flexible ureteroscopy. The stones will be fragmented with holmium-yttrium-aluminum-garnet (YAG) laser and stone fragments will be evacuated by basket or removed through PCNL tract under nephroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients' age ≥ 18 years.
- Patients who are diagnosed as complex renal calculi (Guy's Stone Score (GSS) 3 or 4) as detected by Non-contrast Computed Tomography (NCCT).
Key exclusion criteria (5 listed)
- Renal anatomic anomalies.
- Solitary kidney.
- Coagulation disorders.
- Skeletal deformity.
- Active urinary tract infection.
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 |
|---|---|---|
| Group A (p-PCNL) procedureIn lithotomy position, ureteric catheter will be inserted allowing injection of contrast to obtain a pyelogram. Shifting the patients in prone position will be done. Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out. Amplatz sheath will be inserted to allow nephroscope to enter the collecting system. Stone disintegration will be performed using pneumatic, ultrasonic or laser lithotripsy. Eventually after removal of all stone fragments, a nephrostomy tube will be placed. | Procedure or surgery | Group A (p-PCNL) procedure |
| Group B (s-ECIRS) procedureThe patients will be in Galdakao-Modified Supine Valdivia (GMSV) position . Under fluoroscopic guidance, the desired calyces will be punctured using an 18 G coaxial needle. Then 0.038 mm hydrophilic guidewires will be passed percutaneously through the needle into the pelvis. Using metal dilators dilatation will be carried out till 30 Fr. Amplatz sheath will be inserted to allow a 26 Fr nephroscope to enter the collecting system. Retrograde intrarenal surgery will be applied simultaneously by a second surgeon using flexible ureteroscopy. The stones will be fragmented with holmium-yttrium-aluminum-garnet (YAG) laser and stone fragments will be evacuated by basket or removed through PCNL tract under nephroscopy. | Procedure or surgery | Group B (s-ECIRS) procedure |
Primary outcome
One stage stone free rate
Time frame: first post-operative day
It will include the one-stage SFR which is defined as the number of patients who will show no residual stones or only residual stone fragments < 4 mm in diameter at postoperative day-1 assessment NCCT
2 secondary outcomes
Number of percutaneous access tracts required.
Time frame: during the procedure
Postoperative complications
Time frame: 30 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Ahmed A El-Nahas study director
Mansoura University
Ahmed A Elshal study director
Mansoura 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 Group A (p-PCNL) procedure and Group B (s-ECIRS) procedure in people with Stone, Kidney, run by Mansoura University at 1 site in Egypt.
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 5 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 14 Nov 2022. 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 Egypt. 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 Khaled Allam (0020502202222, k.allam.90.ka50@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One stage stone free rate (time frame: first post-operative day). 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 14 Nov 2022.