Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure

NCT ID: NCT02734914

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-08-31

Brief Summary

This study evaluates the safety and efficacy of the suctioning flexible ureteroscopy(SF-URS) with automatic control of renal pelvic pressure for the treatment of upper urinary calculi using a prospective, randomized design. Half of participants will receive suctioning flexible ureteroscopy with automatic control of renal pelvic pressure, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscopy.

Detailed Description

Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.

However, high perfusion rate leads to renal pelvic pressure increase, resulting in absorption of liquid, bacteria, and endotoxin into blood, followed by short-term complications such as systemic inflammatory response syndrome(SIRS , 8.1%), sepsis (0-4.5%), renal pelvic and ureteral tumor spread, and long-term complication of renal function impairment. Currently the commonly used flexible ureteroscope sheath (ureteral access sheath, UAS) reduces the renal pelvic pressure to a certain extent, but still can not control and monitor the renal pelvic pressure to reduce the incidence of complications, which, limit the clinical application of ureteroscopy.

Recently, the investigators present a novel technique of SF-URS with automatic control of renal pelvic pressure. In this study, transverse comparison is designed to evaluate the safety and efficacy of the suctioning flexible ureteroscopy with automatic control of renal pelvic pressure for the treatment of renal calculi.

Conditions

Renal Calculi

Study Design

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

Study Groups

SF-URS with automatic control of RPP

Participants in SF-URS with automatic control of renal pelvic pressure (RPP) group undergo ureteroscopy using the intelligent pressure control device (Medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with function of pressure measuring).

Group Type: EXPERIMENTAL

SF-URS with automatic control of RPP

Intervention Type: DEVICE

A new F-URS monitoring and control of RPP using intelligent pressure control device

conventional F-URS

Participants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope.

Group Type: ACTIVE_COMPARATOR

conventional F-URS

Intervention Type: DEVICE

Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.

Interventions

SF-URS with automatic control of RPP

A new F-URS monitoring and control of RPP using intelligent pressure control device

Intervention Type: DEVICE

conventional F-URS

Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject has provided informed consent and indicated a willingness to comply with study treatments
• Subject has a diagnosis of renal stones according to computer tomography (CT) results
• Subject is 18-75 yrs of age
• Subject has a single stone < 3 cm in size, or multiple stones < 3 cm in cumulative size
• Subject has a serum creatinine level within the normal range for the study center

Exclusion Criteria

• The patient who do not agree with the intention of the clinical study.
• Subject needs bilateral procedures within one-stage ureteroscopy
• Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.) and severe hematuria
• Subject has been diagnosed with a urethral stricture or bladder neck contracture
• Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
• Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
• Subject has other diseases and could not tolerate the endoscopic surgery
• Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
• Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Ganzhou Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Leming Song

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GanzhouHNU

Identifier Type: -

Identifier Source: org_study_id