Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery

Kidney Stone Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05952635
• Other study ID #: MRER2023-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: June 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Procedure:
• Tip 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.

Locations

Country	Name	City	State
China	Department of Urology, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University	Guizhou Provincial People's Hospital, Jose R. Reyes Memorial Medical Center, Prof. Dr. Ilhan Varank Education and Training Hospital, University of Malaya, Xiangya Hospital of Central South University, Xinchang County Hospital of Traditional Chinese Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate stone-free rate	No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free.	Postoperative day 1
Secondary	Stone-free rate at 3 months	No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free.	Postoperative 3 month
Secondary	Duration of hospital stay		From date of operation until the date of discharge, assessed up to 2 weeks.
Secondary	Further interventions received up to 3 months post randomization		Postoperative 3 month
Secondary	Complications up to 3 months post randomization		Postoperative 3 month
Secondary	Change of Quality of life Score (prior to surgery and at month 3 after randomization)		Postoperative 3 month
Secondary	Operative time	The duration from the insertion of the endoscope into the urethra to the completion of stent placement.	From start of operation until the end of operation, assessed up to 2 weeks.