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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05952635

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), Xinchang Hospital of Traditional Chinese Medicine (Other), Jiangxi Provincial People's Hopital (Other), Xiangya Hospital (Other), Prof. Dr. Ilhan Varank Education and Training Hospital (Other), San Bassiano Hospital (Other), Mt. Carmel Diocesan General Hospital (Other)

320

Enrollment

Location

Arms

Anticipated Duration (Months)

40.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone	Procedure: Tip bendable suction ureteral access sheath	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tip bendable suction ureteral access sheath (S-UAS) group Patients will use S-UAS during flexible ureteroscopy.	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.
No Intervention: Traditional ureteral access sheath group Patients will use traditional UAS during flexible ureteroscopy.

Arm

Intervention/Treatment

Experimental: Tip bendable suction ureteral access sheath (S-UAS) group

Patients will use S-UAS during flexible ureteroscopy.

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.

No Intervention: Traditional ureteral access sheath group

Patients will use traditional UAS during flexible ureteroscopy.

Outcome Measures

Primary Outcome Measures

Immediate stone-free rate [Postoperative day 1]
No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.

Secondary Outcome Measures

Stone-free rate at 3 months [Postoperative 3 month]
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]
Complications up to 3 months post randomization [Postoperative 3 month]
Change of Quality of life Score (prior to surgery and at month 3 after randomization) [Postoperative 3 month]
Patient costs during hospitalization and up to 3 months [Postoperative 3 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults aged ≥ 18 years;
American Society of Anesthesiology score 1-2;
Kidney 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.