Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure

Safety and Efficacy of Suctioning Flexible Ureteroscopy With Automatic Control of Renal Pelvic Pressure : A Clinical Randomized,Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Renal Calculi
• Intervention / Treatment: Device: SF-URS with automatic control of RPP; Device: conventional F-URS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Device: SF-URS with automatic control of RPP; A new F-URS monitoring and control of RPP using intelligent pressure control device
ACTIVE_COMPARATOR: conventional F-URS; Participants in conventional F-URS group undergo ureteroscopy using the classic flexible ureteroscope.	Device: conventional F-URS; Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stone-free rate	Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%	4 weeks post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stone-free rate	Number of participants undergo novel or conventional F-URS surgeries without residual calculus/Total number of participants in each group *100%	One day post-operatively
Complication rates	Number of participants undergo novel or conventional F-URS surgeries suffer complications associated with the surgery (i.e. pain(NRS≥4), hematuria, T≥38℃, serum white blood cell≥12×〖10〗^9/L ,serum white blood cell<4×〖10〗^9/L, perforation, etc.)/Total number of participants in each group *100%	Within 4 weeks after surgery

Collaborators and Investigators

• Sponsor: The Affiliated Ganzhou Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 12, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 12, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: GanzhouHNU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES