Suctioning Flexible Ureteroscopy With Intelligent Control of Renal Pelvic Pressure

Renal Calculi Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02734914
• Other study ID #: GanzhouHNU
• Status: Not yet recruiting
• Phase: N/A
• First received: April 7, 2016
• Last updated: April 11, 2016
• Start date: May 2016
• Est. completion date: August 2018

Study information

• Verified date: April 2016
• Source: The Affiliated Ganzhou Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Calculi

Intervention

Device:
• SF-URS with automatic control of RPP
A new F-URS monitoring and control of RPP using intelligent pressure control device
• conventional F-URS
Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Ganzhou Hospital of Nanchang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes