NCT06085794

Brief Summary

Primary aim: comparing the efficacy of standard PCNL and endoscopic combined intrarenal surgery (ECIRS) in the Galdakao-modified Supine Valdivia (GMSV) position in a single session for the treatment of complex nephrolithiasis in obese patients. Secondary aim: comparing safety and complications of standard PCNL and ECIRS in the GMSV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

September 13, 2023

Last Update Submit

October 10, 2023

Conditions

Renal Stone

Keywords

ECIRSPCNLObese

Outcome Measures

Primary Outcomes (1)

  • Efficacy of PCNL vs ECIRS

    Operative duration in minutes (from positioning to the end of the procedure) will be recorded for the two groups Stone-free status will be evaluated with a plain abdominal radiograph of the kidneys, ureters, and bladder (KUB) for radiopaque stones and NCCT for lucent stones before hospital discharge. Stone-free status is defined as no or small calyceal residuals of ≤ 4 mm (clinically insignificant residual fragment) without infection.

    2 days

Secondary Outcomes (1)

  • Safety and complication of PCNL Vs ECIRS

    1 month.

Study Arms (2)

Percutaneous nephrolithotomy

ACTIVE COMPARATOR

the standard-PCNL group (will be performed by urologists with more than 2 years of experience of PCNL), Fluoroscopic-guided percutaneous renal access will be done for patients in the prone position.

Procedure: Percutaneous nephrolithotomy

Endoscopic combined intrarenal surgery

ACTIVE COMPARATOR

the ECIRS group (will be performed by urologists with more than 2 years of experience of PCNL and RIRS), patients will be oriented in the GMSV position.flexible ureteroscope will be inserted through the access sheath to observe the stone distributions. Under the guidance of fluoroscopy and endoscopic vision, a 18-20 Fr percutaneous tract will be established using sequential fascial dilators and a matching sheath for stone manipulation simultaneously. We use a 12-F nephroscope (Karl Storz).

Procedure: Endoscopic combined intrarenal surgery

Interventions

Endoscopic combined intrarenal surgeryPROCEDURE

Combined complex stone clearance with mini-nephroscope and flexible URS

Also known as: ECIRS
Endoscopic combined intrarenal surgery
Percutaneous nephrolithotomyPROCEDURE

Clearance of renal stone with nephroscope in prone position

Also known as: PCNL
Percutaneous nephrolithotomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Partial or complete staghorn stones)
  • Guy's Stone Score III or IV)
  • Adult (18-60) years old patients
  • Obese \& super-obese patients (BMI \> 30 kg/m 2).

You may not qualify if:

  • Patients with congenital renal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11361, Egypt

RECRUITING

Related Publications (6)

  • Liu YH, Jhou HJ, Chou MH, Wu ST, Cha TL, Yu DS, Sun GH, Chen PH, Meng E. Endoscopic Combined Intrarenal Surgery Versus Percutaneous Nephrolithotomy for Complex Renal Stones: A Systematic Review and Meta-Analysis. J Pers Med. 2022 Mar 28;12(4):532. doi: 10.3390/jpm12040532.

    PMID: 35455648BACKGROUND

  • Cracco CM, Scoffone CM. ECIRS (Endoscopic Combined Intrarenal Surgery) in the Galdakao-modified supine Valdivia position: a new life for percutaneous surgery? World J Urol. 2011 Dec;29(6):821-7. doi: 10.1007/s00345-011-0790-0. Epub 2011 Nov 6.

    PMID: 22057344BACKGROUND

  • Cracco CM, Scoffone CM. Endoscopic combined intrarenal surgery (ECIRS) - Tips and tricks to improve outcomes: A systematic review. Turk J Urol. 2020 Nov;46(Supp. 1):S46-S57. doi: 10.5152/tud.2020.20282. Epub 2020 Aug 25.

    PMID: 32877638BACKGROUND

  • Grosso AA, Sessa F, Campi R, Viola L, Polverino P, Crisci A, Salvi M, Liatsikos E, Feu OA, DI Maida F, Tellini R, Traxer O, Cocci A, Mari A, Fiori C, Porpiglia F, Carini M, Tuccio A, Minervini A. Intraoperative and postoperative surgical complications after ureteroscopy, retrograde intrarenal surgery, and percutaneous nephrolithotomy: a systematic review. Minerva Urol Nephrol. 2021 Jun;73(3):309-332. doi: 10.23736/S2724-6051.21.04294-4. Epub 2021 Apr 22.

    PMID: 33887891BACKGROUND

  • Knoll T, Daels F, Desai J, Hoznek A, Knudsen B, Montanari E, Scoffone C, Skolarikos A, Tozawa K. Percutaneous nephrolithotomy: technique. World J Urol. 2017 Sep;35(9):1361-1368. doi: 10.1007/s00345-017-2001-0. Epub 2017 Jan 25.

    PMID: 28124111BACKGROUND

  • Tawfeek AM, Higazy A, Elkenany MM, Taema K, Arafa H. Mini-Endoscopic Combined Intrarenal Surgery vs Percutaneous Nephrolithotomy in the Management of Complex Nephrolithiasis: A Randomized Controlled Trial. J Endourol. 2025 Oct;39(10):998-1004. doi: 10.1177/08927790251360265. Epub 2025 Jul 18.

    PMID: 40681329DERIVED

MeSH Terms

Conditions

NephrolithiasisObesity

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Moataz bellah M. Adel, Master degree

CONTACT

+201065440699mezzomezzo2@gmail.com

Ahmed M. Higazy, Phd

CONTACT

01002609801Ahmedmaherhigazy@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
1st patient in the PCNL group , 2nd patient in ECIRS group and so on .
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 17, 2023

Study Start

July 25, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

EG(1)