Clinical trial NCT05952635: Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery
Official title: Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery (RIRS): Study Protocol of a Multicentre, Prospective, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Stone
Keywords: Kidney stone
Flexible ureteroscopy
Ureteral access sheath
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiangya Hospital of Central South University
name: Xinchang County Hospital of Traditional Chinese Medicine
name: Prof. Dr. Ilhan Varank Education and Training Hospital
name: Jose R. Reyes Memorial Medical Center
name: Guizhou Provincial People's Hospital
name: University of Malaya
First posted: 2023-07-19
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immediate stone-free rate
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Stone-free rate at 3 months
timeFrame: Postoperative 3 month
measure: Duration of hospital stay
timeFrame: From date of operation until the date of discharge, assessed up to 2 weeks.
measure: Further interventions received up to 3 months post randomization
timeFrame: Postoperative 3 month
measure: Complications up to 3 months post randomization
timeFrame: Postoperative 3 month
measure: Change of Quality of life Score (prior to surgery and at month 3 after randomization)
timeFrame: Postoperative 3 month
measure: Operative time
timeFrame: From start of operation until the end of operation, assessed up to 2 weeks.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: