Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones.

NCT07342361 | Recruiting DMC

• 1 other identifier: 129-2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized study is comparing the safety and efficacy of using two types of ureteral access sheaths in managing staghorn renal stones by retrograde intrarenal surgery.

Conditions

Renal Calculi

Keywords

staghorn calculi; retrograde intrarenal surgery; Ureteral access sheath; Suction

Outcome Measures

Primary Outcomes (1)

• Safety of the surgical technique

  Evaluating and comparing the incidence of operative and postoperative complications

  During surgery to one month after surgery

Secondary Outcomes (1)

• The efficacy of the surgery

  One month after surgery

Study Arms (2)

Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath

ACTIVE COMPARATOR

During retrograde intrarenal surgery, an ureteral access sheath with bendable tip \& connected to suction system will be used.

Procedure: Retrograde intrarenal surgery

Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath

PLACEBO COMPARATOR

During retrograde intrarenal surgery, a conventional ureteral access sheath will be used.

Procedure: Retrograde intrarenal surgery

Interventions

Retrograde intrarenal surgery PROCEDURE

Retrograde intrarenal surgery with using laser for management of renal staghorn stones

Group (1): Retrograde intrarenal surgery using a bendable tip-suction ureteral access sheath; Group (2): Retrograde intrarenal surgery using a conventional ureteral access sheath

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients of both sexes.
• Patient has a staghorn renal stone (complete or partial staghorn).
• Normal renal function tests.
• Congenital renal anomalies as horseshoe, pelvic or mal-rotated kidneys.

You may not qualify if:

• Abnormal coagulation profile.
• Active or untreated urinary tract infection.
• Age under 18 years or above 70 years.
• Patient has a staghorn stone associated with other pathology which requires additional intervention, as ureteral stricture or ureteropelvic junction obstruction (UPJO).
• Pregnancy.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Faculty of medicine, Helwan University

Cairo, 11795, Egypt

RECRUITING

Related Publications (5)

• Bai Y, Wang X, Yang Y, Han P, Wang J. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for the treatment of kidney stones up to 2 cm in patients with solitary kidney: a single centre experience. BMC Urol. 2017 Jan 18;17(1):9. doi: 10.1186/s12894-017-0200-z.

  PMID: 28100225 BACKGROUND

• Liang H, Liang L, Lin Y, Yu Y, Xu X, Liang Z, Sheng J, Shen B. Application of tip-bendable ureteral access sheath in flexible ureteroscopic lithotripsy: an initial experience of 224 cases. BMC Urol. 2023 Nov 1;23(1):175. doi: 10.1186/s12894-023-01347-x.

  PMID: 37915008 BACKGROUND

• Kaplan AG, Lipkin ME, Scales CD Jr, Preminger GM. Use of ureteral access sheaths in ureteroscopy. Nat Rev Urol. 2016 Mar;13(3):135-40. doi: 10.1038/nrurol.2015.271. Epub 2015 Nov 24.

  PMID: 26597613 BACKGROUND

• Zeng G, Zhao Z, Mazzon G, Pearle M, Choong S, Skolarikos A, Denstedt J, Seitz C, Olvera Pasada D, Fiori C, Bosio A, Papatsoris A, Mendez Probst CE, Perez Fentes D, Ann Git K, Wu Q, Wiseman O, Emiliani E, Farahat Y, Ilker Gokce M, Giannakopoulos S, Goumas Kartalas I, Somani B, Knoll T, de la Rosette J, Zhong J, Vinicius Maroccolo M, Saltirov L, Chew B, Wang K, Lahme S, Giusti G, Ferretti S, Yong Cho S, Geavlete P, Cansino R, Kamphuis GM, Smith D, Matlaga BR, Ghani KD, Bernardo N, Silva AD, Ng ACF, Yang S, Gao X, Traxer O, Miernik A, Liatsikos E, Priyakant Parikh K, Duvdevani M, Celia A, Yasui T, Aquino A, Alomar M, Choonhaklai V, Erkurt B, Glass J, Sriprasad S, Osther PJ, Keeley FX Jr, Preminger GM, Cepeda Delgado M, Beltran Suarez E, Ye Z, Sarica K. European Association of Urology Section of Urolithiasis and International Alliance of Urolithiasis Joint Consensus on Retrograde Intrarenal Surgery for the Management of Renal Stones. Eur Urol Focus. 2022 Sep;8(5):1461-1468. doi: 10.1016/j.euf.2021.10.011. Epub 2021 Nov 24.

  PMID: 34836838 BACKGROUND

• Keller EX, De Coninck V, Doizi S, Traxer O. The role of ureteroscopy for treatment of staghorn calculi: A systematic review. Asian J Urol. 2020 Apr;7(2):110-115. doi: 10.1016/j.ajur.2019.10.012. Epub 2019 Dec 5.

  PMID: 32257803 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Staghorn Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed H Elsergany, MSc

  Helwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed H Elsergany, MSc.

CONTACT

+20 1151405155; dr_sergany2014@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 15, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)