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

NCT ID: NCT05952635

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-06-21

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.

Conditions

Kidney Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Patients will use S-UAS during flexible ureteroscopy.

Group Type: EXPERIMENTAL

Tip bendable suction ureteral access sheath

Intervention Type: PROCEDURE

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.

Traditional ureteral access sheath group

Patients will use traditional UAS during flexible ureteroscopy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Xinchang County Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Prof. Dr. Ilhan Varank Education and Training Hospital

UNKNOWN

Sponsor Role: collaborator

Jose R. Reyes Memorial Medical Center

OTHER_GOV

Sponsor Role: collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role: collaborator

University of Malaya

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guohua Zeng

Vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Urology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

References

Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.

Reference Type: DERIVED

PMID: 39070176 (View on PubMed)

Other Identifiers

MRER2023-001

Identifier Type: -

Identifier Source: org_study_id