Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Flexible Ureteroscope

NCT05201599 | Unknown

• 1 other identifier: MRER(49)2021
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to compare the efficacy and safety of flexible ureteroscope with intelligent control of renal pelvic pressure (FURL-ICP) and traditional flexible ureteroscope(f-URL) in the treatment of upper urinary stones ≤ 2cm in diameter. It is designed as a multicenter, parallel randomized controlled trial with two arms. At least 449 patients with upper urinary stones ≤ 2cm in diameter will be invited to participant in this study. Patients will be assigned to intervention group (FURL-ICP group) or control group (f-URL) by a simple random sampling technique with a rate of 1:1. The baseline of participants include demographic data, urine analysis, blood cell analysis, blood biochemical analysis, and urinary computer tomography (CT) with a slice thickness of 2mm. The primary outcomes are postoperative stone-free rate (SFR) of one month by CT scan and postoperative fever rate (body temperature \> 38.5 ℃ within 3 days after operation). Secondary outcomes include operating time, degree of ureteral injury, SFR of one day.

Conditions

Urinary Calculi

Keywords

upper urinary stone; flexible ureteroscope; vacuum suction; stone free rate

Outcome Measures

Primary Outcomes (1)

• Stone free rate for one month

  Stone free rate for one month after surgery by CT scan with a thickness of 2mm.

  One month after surgery

Secondary Outcomes (4)

• Stone free rate for one day

  One day after surgery

• Postoperative fever rate

  Within 3 days after operation

• Operating time

  During the operation

• Degree of ureteral injury

  During the operation

Study Arms (2)

Flexible ureteroscope with intelligent control of renal pelvic pressure(FURL-ICP)

EXPERIMENTAL

Patients will be placed in supine lithotomy position with 60-90° oblique on the affected side upward. A pressure measuring ureteral access sheath (UAS) (11-14Fr) is inserted into the proximal ureter along the guidewire without fluoroscopic guidance. The pressure sensory and suctioning channels are connected to the irrigation and suctioning platform.

Device: Flexible ureteroscope with intelligent control of renal pelvic pressure

Traditional flexible ureteroscope(f-URL)

NO INTERVENTION

Each procedure is completed under general anesthesia in lithotomy position. A semi-rigid ureteroscopy is used to place a 0.032-inch guidewire. A pressure measuring ureteral access sheath (UAS) (11-14Fr) is inserted into the proximal ureter along the guidewire without fluoroscopic guidance. The irrigation and suctioning platform will be not used. A 7.5 Fr flexible ureteroscopy is used to break the stone with a holmium laser (fiber diameter 200 µm). A basket is used to remove the stone fragments. A 4-6Fr ureteral stent is left for 2 weeks after the operation. Stone composition is analyzed. If the UAS is failed to be placed, ureteral stent will be placed for 2 weeks and a second stage traditional f-URL will be performed.

Interventions

Flexible ureteroscope with intelligent control of renal pelvic pressure DEVICE

After adjusting the UAS in suitable position, the pressure sensory and suctioning channels are connected to the irrigation and suctioning platform. After being injected with water, a zero calibration is performed for the pressure sensory system. A fully automatic mode is selected on the platform. The perfusion flow is set between 50 to 150 mL/min. The RPP control value is set between -15 to -5 mmHg. The renal pelvic pressure alarm value is set between 20 to 30mmHg. During the operation, a holmium laser is used to break stones into powder (fiber diameter 200 µm), and the flexible ureteroscopy is moved back and forward slightly to suck out the stone particles inside the sheath gap. Particles larger than the sheath gap but smaller than the UAS is sucked out by intermittently withdrawing the flexible ureteroscope without basket.

Flexible ureteroscope with intelligent control of renal pelvic pressure(FURL-ICP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diameter of single stone or cumulative maximum diameter for multiple stones is less than or equal to 2cm
• American Society of Anesthesiology scores of 1to 2
• All patients participate in this study voluntarily and signed informed consent

You may not qualify if:

• Uncontrolled urinary tract infection
• Patients with pyonephrosis are found during operation
• The patients with abnormal anatomy (heterotopic kidney, horseshoe kidney, duplicate kidney), ureteral stricture, urethral stricture and urinary diversion
• Severe hydronephrosis
• Renal function was decompensated (serum creatinine \> 178 μmol/L)
• Severe systemic hemorrhagic disease
• Patients who underwent bilateral surgery at the same time
• Severe deformity of hip joint and difficult position

Sponsors & Collaborators

• Guohua Zeng: lead
• First Affiliated Hospital of Jinan University: collaborator
• Southern Medical University, China: collaborator
• The Affiliated Ganzhou Hospital of Nanchang University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Jiangxi Provincial People's Hopital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Fujian Provincial Hospital: collaborator
• First People's Hospital of Yulin: collaborator
• Henan Provincial People's Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Affiliated Hospital of Guangdong Medical University: collaborator

Study Sites (1)

The Affiliated Ganzhou Hospital of Nanchang University (Ganzhou People's Hospital)

Ganzhou, Jiangxi, 341000, China

RECRUITING

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MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Guohua Zeng, Doctor

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Zanlin Mai, Doctor

CONTACT

8613580359786; maizanlin1001@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Patients with upper urinary stones ≤ 2cm in diameter will be assigned to intervention group (FURL-ICP group) or control group (f-URL) by a simple random sampling technique with a rate of 1:1.

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: January 21, 2022
• Study Start: August 11, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)