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Standard PCNL Vs Endoscopic Combined Intrarenal Surgery (ECIRS) for Complex Nephrolithiasis in Obese Patients (ECIRS)

Primary Purpose

Renal Stone

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic combined intrarenal surgery
Percutaneous nephrolithotomy
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stone focused on measuring ECIRS, PCNL, Obese

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Exclusion Criteria: Patients with congenital renal anomalies

Sites / Locations

  • Ain Shams University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Percutaneous nephrolithotomy

Endoscopic combined intrarenal surgery

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety and complication of PCNL Vs ECIRS
Intraoperative complications will be recorded and 30-day postoperative complications will be graded according to the modified Clavien classification.

Full Information

First Posted
September 13, 2023
Last Updated
October 10, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06085794
Brief Title
Standard PCNL Vs Endoscopic Combined Intrarenal Surgery (ECIRS) for Complex Nephrolithiasis in Obese Patients
Acronym
ECIRS
Official Title
Comparative Study Between Standard PCNL and Endoscopic Combined Intrarenal Surgery (ECIRS) in the Galdakaomodified Supine Valdivia (GMSV) Position for Complex Nephrolithiasis in Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Complex nephrolithiasis including multiple peripheral or branched (partial or complete staghorn calculi) renal stones, is still currently an intractable problem for urologists to achieve stone-free status and minimize complication rates. According to the European Association of Urology Urolithiasis Guidelines, retrograde intrarenal surgery (RIRS) is recommended as first-line treatment for renal stones < 2 cm, and percutaneous nephrolithotomy (PCNL) is recommended as the gold standard for renal stones ≥ 2 cm in length. Obesity has been identified as an independent risk factor for stone formation in the United States. Obesity (BMI >35) also places surgical patients at a greater risk of complications, because of the increased incidence in this group of diabetes, hypertension, ischemic heart disease, postoperative deep venous thrombosis, and pulmonary embolism, and because of poor radiographic visualization, obscure anatomic landmarks, more difficult renal access, and inferior stone-free rates. Standard percutaneous nephrolithotomy (PCNL) is the recommended treatment by major guidelines. However, multiple tracts or sessions of PCNL were required to obtain a high stone-free rate (SFR) for complex renal calculi, especially staghorn stones, while procedure-related complications increased concomitantly. To acquire a higher SFR, full access to the entire intrarenal collecting system is the final goal of treatment for these patients suffering from multiple calyceal or peripheral satellite calculi, which is technically challenging by means of RIRS or PCNL monotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone
Keywords
ECIRS, PCNL, Obese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
1st patient in the PCNL group , 2nd patient in ECIRS group and so on .
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous nephrolithotomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Endoscopic combined intrarenal surgery
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Endoscopic combined intrarenal surgery
Other Intervention Name(s)
ECIRS
Intervention Description
Combined complex stone clearance with mini-nephroscope and flexible URS
Intervention Type
Procedure
Intervention Name(s)
Percutaneous nephrolithotomy
Other Intervention Name(s)
PCNL
Intervention Description
Clearance of renal stone with nephroscope in prone position
Primary Outcome Measure Information:
Title
Efficacy of PCNL vs ECIRS
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Safety and complication of PCNL Vs ECIRS
Description
Intraoperative complications will be recorded and 30-day postoperative complications will be graded according to the modified Clavien classification.
Time Frame
1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Patients with congenital renal anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moataz bellah M. Adel, Master degree
Phone
+201065440699
Ext
02
Email
mezzomezzo2@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M. Higazy, Phd
Phone
01002609801
Ext
02
Email
Ahmedmaherhigazy@gmail.com
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed

12. IPD Sharing Statement

Citations:
PubMed Identifier
35455648
Citation
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.
Results Reference
background
PubMed Identifier
22057344
Citation
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.
Results Reference
background
PubMed Identifier
32877638
Citation
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.
Results Reference
background
PubMed Identifier
33887891
Citation
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.
Results Reference
background
PubMed Identifier
28124111
Citation
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.
Results Reference
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Standard PCNL Vs Endoscopic Combined Intrarenal Surgery (ECIRS) for Complex Nephrolithiasis in Obese Patients

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