Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery

NCT06249100 | Completed Phase 2 DMC

• 1 other identifier: MD 351/2023
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The use of flexible ureteroscopy and minimally-invasive percutaneous techniques, which utilize smaller tract sizes, has been established as a way to decrease the invasiveness of procedures and improve patient outcomes compared to conventional percutaneous nephrolithotomy (PCNL) and flexible mini-PCNL has emerged as a novel technique previously first as an auxiliary procedure and then as a standalone technique. This study aims to assess the feasibility and effectiveness of flexible nephoscopy in improving stone clearance compared to standard retrograde intrarenal surgery using a flexible ureteroscope.

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• stone-free rate

  patients will be considered stone free, if the stone residual in the follow up is less than 4mm

  1 month postoperative

Secondary Outcomes (5)

• Operative time

  24 hour postoperative

• Hospital Stay

  1 month postoperative

• Cost analysis

  1 month postoperative

• infection rate

  up to 1 month postoperative

• Hemoglobin drop

  1 day postoperative

Study Arms (2)

flexible mini percutaneous nephrolithotomy

EXPERIMENTAL

In Group A (flexible mini-PCNL cases), puncture will be done under fluoroscopic guidance medial to the posterior axillary line using an 18-gauge puncture needle. The puncture will be directed horizontally or with slight upward inclination towards lower or middle calyx. After a successful puncture, a 0.035 Fr Super Stiff guidewire will be inserted either to the ureter or to another calyx. Tract dilatation will be done with Storz 15/16 Fr one step metal dilator followed by 16.5 Fr access sheath. Stone disintegration will be done with the flexible mini-nephroscopy (WiScope Digital Endoscope System by OTU Medical, California, USA) which has a shaft length of 38 cm, distal tip diameter is 15.3 F tapering to 10 F, working channel inner diameter is 6.6 F, and the angle of deflection of distal tip is 210 degrees.

Procedure: flexible mini percutaneous nephrolithotomy

retrograde intrarenal surgery

ACTIVE COMPARATOR

In Group B (retrograde intrarenal surgery cases), a 0.035 Fr guidewire will be inserted into the ureteric orifice under fluoroscopic guidance. Ureteric dilatation will be done with serial semi-rigid dilators 6- 16 Fr (Nidhi Meditech) followed by 14-16 Fr access sheath. Stone disintegration will be done with the LithoVue Flexible URS (Boston Scientific, Massachusetts, U.S.) which has a shaft length of 68 cm, distal tip diameter is 7.7-10 F, working channel inner diameter is 3.6 F, and the angle of deflection of distal tip is 270 degrees.

Procedure: Retrograde intrarenal surgery

Interventions

flexible mini percutaneous nephrolithotomy PROCEDURE

In Group A (flexible mini-PCNL cases), a puncture will be done under fluoroscopic guidance medial to the posterior axillary line using an 18-gauge puncture needle. The puncture will be directed horizontally or with a slight upward inclination towards the lower or middle calyx. After a successful puncture, a 0.035 Fr Super Stiff guidewire will be inserted. Tract dilatation with amplatz dilator followed by access sheath insertion. Stone disintegration will be done with the flexible mini-nephroscopy (WiScope Digital Endoscope System by OTU Medical, California, USA) which has a shaft length of 38 cm, distal tip diameter is 15.3 F tapering to 10 F, working channel inner diameter is 6.6 F, and the angle of deflection of the distal tip is 210 degrees.

flexible mini percutaneous nephrolithotomy

Retrograde intrarenal surgery PROCEDURE

n Group B, Flexible ureteroscopy will be used with a ureteral access sheath and laser fragmentation of renal stones will be done

retrograde intrarenal surgery

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients above the age of 16 years of either sex presented to the Urology clinic in our university hospitals
• kidney stones with a size not exceeding 3.0 cm (estimated by CTUT as the greatest dimension or the summation of the greatest dimensions in case of more than one stone detected)

You may not qualify if:

• Patients with lumber hernia on the same site of the surgery
• Patients with a stone burden exceeding 3cm
• Patients with renal anomalies preventing access
• Patients with coagulopathies/bleeding tendency
• Patients with untreated or active UTI

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11361, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 8, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)