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

Primary Purpose

Urinary Calculi

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flexible ureteroscope with intelligent control of renal pelvic pressure
Sponsored by
Guohua Zeng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Calculi focused on measuring upper urinary stone, flexible ureteroscope, vacuum suction, stone free rate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Traditional flexible ureteroscope(f-URL)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stone free rate for one day
Stone free rate for one day after surgery by X-ray.
Postoperative fever rate
Postoperative fever rate (body temperature > 38.5°C within 3 days after operation
Operating time
Operating time
Degree of ureteral injury
Degree of ureteral injury

Full Information

First Posted
October 6, 2021
Last Updated
January 20, 2022
Sponsor
Guohua Zeng
Collaborators
First Affiliated Hospital of Jinan University, Southern Medical University, China, The Affiliated Ganzhou Hospital of Nanchang University, The First Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Xiamen University, Fujian Provincial Hospital, First People's Hospital of Yulin, Henan Provincial People's Hospital, People's Hospital of Guangxi, Affiliated Hospital of Guangdong Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05201599
Brief Title
Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Flexible Ureteroscope
Official Title
Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Flexible Ureteroscope With Intelligent Control of Renal Pelvic Pressure(FURL-ICP): a Multicenter, Parallel, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guohua Zeng
Collaborators
First Affiliated Hospital of Jinan University, Southern Medical University, China, The Affiliated Ganzhou Hospital of Nanchang University, The First Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, The First Affiliated Hospital of Xiamen University, Fujian Provincial Hospital, First People's Hospital of Yulin, Henan Provincial People's Hospital, People's Hospital of Guangxi, Affiliated Hospital of Guangdong Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background Urinary stone is a common disease with a prevalence rate of 5-15%. It has a recurrence rate of 50% for 5-10 years, and about 75% for 20 years. It is a heavy healthy burden to the population. Flexible ureteroscope lithotripsy(f-URL) is a first-line treatment for renal stone ≤ 2cm in diameter. It has the advantage of less trauma, low complications and fast recovery. It is also suitable for upper ureteral calculi, residual calculi after percutaneous nephrolithotomy (PCNL) It can also be combined with PCNL for the treatment of complex renal calculi. The postoperative stone free rate of f-URL varies drastically due to different sizes of residual stone. The Chinese consensus of flexible ureteroscopy recommended that stone ≤ 4mm in diameter should be considered as clinical insignificant residual stone. When residual stone was defined as ≤ 3mm, the stone free rate for one-month was 90% of renal stones ≤ 20 mm, and was 74.4% for stone of 10-25 mm. It would not cause significant symptoms when the residual stone ≤ 2 mm. Based on this definition, Fatih A's randomized trial showed that the stone free rate of f-URL for renal calculi ≤ 20 mm was 85.7%. It was only 30% for stone > 20 mm of single procedure,86.6% of secondary procedure, and 100% for tertiary procedure. When the residual stone was defined as ≤ 1 mm, the stone free rate of f-URL was 64.7% for a single procedure, 92% for secondary procedure, and the overall stone free rate was 85.1% and 100% for stone > 20 mm and ≤ 20 mm respectively by a retrospective study. When the stone free rate was defined as complete stone clearance, it was 71% after one month of single f-URL for renal stone >30mm . Postoperative infection is a common complication of f-URL. The key point to avoid postoperative infection includes to treat urinary infection, to keep a low flow perfusion and renal pelvic pressure (RPP) during operation, and to control the operation time. The renal pelvic pressure depends on the size of ureteral sheath and flexible ureteroscope, the flow of perfusion and outflow of traditional f-URL. It is difficult to realize real-time monitoring and regulation of renal pelvic pressure during the operation. To realize a high stone free rate and a low postoperative infection rate of f-URL, a new system named flexible ureteroscope with intelligent control of renal pelvic pressure (FURL-ICP) is designed and used. It has an irrigation and suctioning control platform, uses a ureteral access sheath with a pressure-sensitive tip, enables regulation of the infusion flow precisely, and controls the vacuum suctioning by computerized real-time recording and monitoring of RPP. A stable RPP is kept within a pre-set safe range by pressure feedback technology. The stone power could be sucked out during operation. Previous data showed that postoperative stone free rate was 90% for one day, and 95.6% for one month after operation respectively, and the overall complication rate was 14.4%. The aim of this study is to compare the efficacy and safety for FURL-ICP and f-URL in the treatment of upper urinary calculi with diameter ≤ 2cm. Objective To compare the efficacy and safety of FURL-ICP and traditional FURL for the treatment of ≤ 2cm upper urinary stones. Trial Design and Participants The trial is designed as a multicenter, parallel, randomized controlled trial with two arms. Patients will be recruited from 12 Chinese tertiary medical centers. Each participating center performed >50 f-URLs per month. Patients with upper urinary tract stones scheduled for f-URL will be invited in this study. Randomization and masking Central randomized allocation will be used without stratification. Participants will be assigned by a simple random sampling technique with a rate of 1:1. A randomization list is generated by a statistician and securely stored at a password-protected computer of the sponsor's center. Only one protocol-blinded coordinator will know the password and reveal the assignments in sequence to each center. The allocation is revealed before the surgery day. One-side superiority test is designed to compare the efficacy and safety of FURL-ICP and f-URL. Sample size Sample size is estimated by SFR of one month for f-URL. Complete stone free is defined as residual stone ≤ 2mm in diameter. The SFRs of FURL-ICP and traditional f-URL are presumed to be 90% (PT) and 75% (PC) respectively, based on previous data. 5% is considered as an inferior margin. The sample size is calculated with the formulas of a one-side superiority test comparing two proportions. The minimum sample size for each group was 224, and at least 449 cases are needed in the study. (https://www.cnstat.org/statx/compute.html). Intervention methods: (1)Operation methods of intervention group(FURL-ICP): Each procedure is completed under general anesthesia in supine lithotomy position with 60-90° oblique on the affected side upward. A semi-rigid ureteroscopy is used to check the urinary tract system and to place a 0.032-inch guidewire. A pressure measuring ureteral access sheath (UAS) (11/13.8Fr) is inserted into the proximal ureter along the guidewire without fluoroscopic guidance. A 7.5 Fr flexible ureteroscopy is used to check the delivery location of the UAS, mucosa of renal pelvis and ureter. 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 ureteroscopy without basketing. 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 FURL-ICP will be performed. (2)Operation methods of control group(traditional f-URL): 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) (11/13.8Fr) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Calculi
Keywords
upper urinary stone, flexible ureteroscope, vacuum suction, stone free rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
449 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flexible ureteroscope with intelligent control of renal pelvic pressure(FURL-ICP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional flexible ureteroscope(f-URL)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Flexible ureteroscope with intelligent control of renal pelvic pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone free rate for one month
Description
Stone free rate for one month after surgery by CT scan with a thickness of 2mm.
Time Frame
One month after surgery
Secondary Outcome Measure Information:
Title
Stone free rate for one day
Description
Stone free rate for one day after surgery by X-ray.
Time Frame
One day after surgery
Title
Postoperative fever rate
Description
Postoperative fever rate (body temperature > 38.5°C within 3 days after operation
Time Frame
Within 3 days after operation
Title
Operating time
Description
Operating time
Time Frame
During the operation
Title
Degree of ureteral injury
Description
Degree of ureteral injury
Time Frame
During the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zanlin Mai, Doctor
Phone
8613580359786
Email
maizanlin1001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Doctor
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Ganzhou Hospital of Nanchang University (Ganzhou People's Hospital)
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolin Deng, Doctor
Phone
18770738881
Email
279971368@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
When the study is finished, we will shared data with other researchers.
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Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://pan.baidu.com/s/1PNKfPWrpeJtodX1RwH8k-w
Available IPD/Information Identifier
zxt4

Learn more about this trial

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

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