Kidney Stone
Conditions
Keywords
Kidney stone, Flexible ureteroscopy, Ureteral access sheath
Brief summary
Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world\[1,2\]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications. The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend \>90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.
Interventions
PROCEDURETip bendable suction ureteral access sheath
Patient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xiangya Hospital of Central South University
Xinchang County Hospital of Traditional Chinese Medicine
Prof. Dr. Ilhan Varank Education and Training Hospital
Jose R. Reyes Memorial Medical Center
Guizhou Provincial People's Hospital
University of Malaya
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥ 18 years; * American Society of Anesthesiology score 1-3; * Upper urinary stone (kidney stone or upper ureteral stone) diameter of ≤ 3 cm confirmed by CT; * Capable of giving written informed consent, which includes adherence with the requirements of the trial.
Exclusion criteria
* Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit); * Patients with uncontrolled UTI; * Patients with health or other factors that are absolute contraindications to RIRS; * Patients unable to understand or complete trial documentation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate stone-free rate | Postoperative day 1 | No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | From date of operation until the date of discharge, assessed up to 2 weeks. | — |
| Further interventions received up to 3 months post randomization | Postoperative 3 month | — |
| Stone-free rate at 3 months | Postoperative 3 month | No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free. |
| Change of Quality of life Score (prior to surgery and at month 3 after randomization) | Postoperative 3 month | — |
| Operative time | From start of operation until the end of operation, assessed up to 2 weeks. | The duration from the insertion of the endoscope into the urethra to the completion of stent placement. |
| Complications up to 3 months post randomization | Postoperative 3 month | — |
Countries
China
Outcome results
None listed