Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy

NCT05911945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-06-23

No results posted yet for this study

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

Interventions

PROCEDURE

Flexible Ureterorenoscopy

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.

PROCEDURE

Mini Percutaneous Nephrolithotomy

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.

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Principal Investigators

  • Mehmet Akbulut, Assoc. Prof · Haseki Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2021-09-10
Completion
2021-12-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05911945 on ClinicalTrials.gov