Endoscopic Combined Intrarenal Surgery Versus Multi-Tract Percutaneous Nephrolithotomy for Complex Renal Stones:
1 other identifier
interventional
110
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedNovember 14, 2022
November 1, 2022
1.8 years
July 13, 2022
November 8, 2022
Conditions
Outcome Measures
Primary Outcomes (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
first post-operative day
Secondary Outcomes (2)
Number of percutaneous access tracts required.
during the procedure
Postoperative complications
30 days after intervention
Study Arms (2)
Group A (p-PCNL) procedure
ACTIVE 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.
Group B (s-ECIRS) procedure
EXPERIMENTALThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Renal anatomic anomalies.
- Solitary kidney.
- Coagulation disorders.
- Skeletal deformity.
- Active urinary tract infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura Urology and Nephrology Center
Al Mansurah, Outside U.S./Canada, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed A El-Nahas
Mansoura University
- STUDY DIRECTOR
Ahmed A Elshal
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Urology
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 15, 2022
Study Start
March 1, 2022
Primary Completion
December 1, 2023
Study Completion
January 1, 2024
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share