Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy

NCT05911945 | Completed

• 1 other identifier: 256040791
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous nephrolithotomy (PNL) is the gold standard recommended treatment technique for kidney stones larger than 20 mm. For kidney stones between 10 - 20 mm, both shock wave lithotripsy (SWL) or flexible ureterorenoscopy (f-URS) are recommended as the first choice of treatment and PNL is recommended as the second. In patients who are planned to undergo f-URS, a ureteral access sheath (UAS) is placed in the ureter at the beginning of the operation in order to provide a better image, reduce intra-renal pressure, easier stone fragment retrieval and shorter operative time. In certain cases, such as ureteral stricture, kink or edema, the ureteral access sheath may not be able to successfully inserted into the ureter. At this stage, double-J (JJ) stent can be inserted into the ureter to create passive dilatation, and a second f-URS session can be scheduled a few weeks later. Another option is to perform PNL operation to the patient in the same session. In this randomized prospective study, we aimed to compare these two different surgical approaches in terms of patient comfort and surgical success in patients with kidney stones between 10 - 20 mm in which access sheath insertion was failed in the initial f-URS session.

Conditions

Kidney Calculi

Keywords

kidney calculi; percutaneous nephrolithotomy; retrograde intrarenal surgery; quality of life

Outcome Measures

Primary Outcomes (1)

• Short Form-36 parameters

  In order to evaluate the quality of life of the patients, pre- and postoperative SF-36 form values will be compared.

  Before surgery - 1 month after surgery

Secondary Outcomes (1)

• The success of the surgery

  Before surgery - 1 month after surgery

Study Arms (2)

Flexible Ureterorenoscopy

ACTIVE COMPARATOR

Underwent a JJ stent insertion and underwent f-URS 4-6 weeks later (Group 1).

Procedure: Flexible Ureterorenoscopy

Mini Percutaneous Nephrolithotomy

ACTIVE COMPARATOR

Underwent mPNL operation in the same session after prone positioning (Group 2).

Procedure: Mini Percutaneous Nephrolithotomy

Interventions

Flexible Ureterorenoscopy PROCEDURE

A guidewire was placed in the ureter in the lithotomy position. Ureterorenoscopy was performed with an 8 Fr ureterorenoscope for active dilatation. An 11 - 13 Fr or 9.5 / 11.5 Fr UAS was attempted to be placed under fluoroscopy by the surgeon of the procedure. In cases where the UAS could not inserted, a 26 cm, 4.8 Fr JJ stent was placed under fluoroscopy and the procedure was terminated. Patients underwent a second f-URS session, 4 - 6 weeks later. After the JJ stent was removed, an 11 - 13 Fr UAS was placed in the ureter. Digital flexible ureterorenoscope was used as the flexible ureteroscope. Stone fragmentation was performed in dusting mode using a Ho:YAG laser with a 272 µ probe. After fragmentation, a 26 cm 4.8 Fr JJ stent was inserted into the ureter. The JJ stent was removed at 4 - 6 weeks postoperatively.

Flexible Ureterorenoscopy

Mini Percutaneous Nephrolithotomy PROCEDURE

A guidewire was placed in the ureter in the lithotomy position. Ureterorenoscopy was performed with an 8 Fr ureterorenoscope for active dilatation. An 11 - 13 Fr or 9.5 / 11.5 Fr UAS was attempted to be placed under fluoroscopy by the surgeon of the procedure. In cases where the UAS could not inserted, patients were positioned in prone position and access was performed to the appropriate calyx with an 18-gauge percutaneous access needle using the triangulation technique accompanied by fluoroscopy, in the same session. After the guidewire was introduced into the pelvicalyceal system, sequential dilatation was applied with Amplatz dilatators, and a 21 Fr metallic sheath was placed. Stones were fragmented with a yttrium-aluminum-garnet (Ho:YAG) Laser lithotripter. At the end of the procedure, a 14 Fr nephrostomy catheter was placed in according to the residual stone, hemorrhage, and perforation status. In other cases, the procedure was concluded as totally tubeless.

Mini Percutaneous Nephrolithotomy

Eligibility Criteria

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

You may qualify if:

• Patients with renal calculi between 1 - 2 cm in diameter
• Patients who were unsuitable for SWL treatment or who did not benefit from SWL sessions

You may not qualify if:

• Patients with kidney anomalies, (malrotated and horseshoe kidneys, kidneys with duplicated systems)
• Pregnant patients
• Patients younger than 18 years of age

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Related Publications (3)

• Jiang K, Zhang P, Xu B, Luo G, Hu J, Zhu J, Sun F. Percutaneous Nephrolithotomy vs. Retrograde Intrarenal Surgery for Renal Stones Larger than 2cm in Patients with a Solitary Kidney: A Systematic Review and a Meta-Analysis. Urol J. 2020 Jul 28;17(5):442-448. doi: 10.22037/uj.v16i7.5609.

  PMID: 32748387 BACKGROUND

• Bensalah K, Tuncel A, Gupta A, Raman JD, Pearle MS, Lotan Y. Determinants of quality of life for patients with kidney stones. J Urol. 2008 Jun;179(6):2238-43; discussion 2243. doi: 10.1016/j.juro.2008.01.116. Epub 2008 Apr 18.

  PMID: 18423704 BACKGROUND

• Perez-Fentes DA, Gude F, Blanco B, Freire CG. Percutaneous nephrolithotomy: short- and long-term effects on health-related quality of life. J Endourol. 2015 Jan;29(1):13-7. doi: 10.1089/end.2014.0081.

  PMID: 24708396 BACKGROUND

MeSH Terms

Conditions

Kidney 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

• Mehmet Akbulut, Assoc. Prof

  Haseki Training and Research Hospital

  STUDY DIRECTOR

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: M.D

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: September 10, 2020
• Primary Completion: September 10, 2021
• Study Completion: December 1, 2021
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)