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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • 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

    Recruiting

Other trials in Egypt

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 groups in NCT05460559
Study groupRoleWhat they receive
Group A (p-PCNL) procedureActive comparatorIn 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) procedureExperimentalThe 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.

  1. 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)
  1. Number of percutaneous access tracts required.

    Number of percutaneous access tracts required.

    Measured: during the procedure

  2. 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.

  1. First posted15 Jul 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Resources

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)
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

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.

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