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The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones

Primary Purpose

Urologic Diseases, Stones, Kidney, Stone, Urinary

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bidirectional Shock Wave Lithotripsy
Standard Shock Wave Lithotripsy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Diseases focused on measuring Shock wave lithotripsy, Bidirectional, Stones

Eligibility Criteria

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

Inclusion Criteria:

  • Patient criteria:

    1. Ability to give informed consent.
    2. Normal laboratory profile as regarding serum creatinine, liver function, platelets count and prothrombin time.
  • Stone criteria:

    1. Single renal stone less than two cm or upper lumbar ureteric stone less than one cm.
    2. Radio-opaque stones.

Exclusion Criteria:

  1. Bleeding tendency.
  2. Poor kidney function.
  3. Pregnancy.
  4. Abdominal aortic aneurysm.
  5. Indwelling DJ ureteric stent or percutaneous nephrostomy tube (PCN).
  6. Congenital anomalies of the urinary tract.
  7. Untreated urinary tract infection.
  8. Obstructed urinary tract distal to the stone.

Sites / Locations

  • Urology and Nephrology center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bidirectional Shock Wave Lithotripsy

Standard Shock Wave Lithotripsy

Arm Description

alternating bidirectional (under and over table) approach

standard unidirectional approach

Outcomes

Primary Outcome Measures

stone free rate three months after the last session
residual less than 4 mm by non-contrast computerized tomography scan (NCCT)

Secondary Outcome Measures

severity of complications after SWL in both groups
Clavien-Dindo scale of surgical complications

Full Information

First Posted
July 29, 2017
Last Updated
August 7, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03243682
Brief Title
The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones
Official Title
The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones. A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
March 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

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

5. Study Description

Brief Summary
compare the outcomes of SWL for renal and upper lumbar ureteric stones using the alternating bidirectional approach versus the standard approach.
Detailed Description
Shock wave lithotripsy (SWL) has been considered the preferred method for treating upper urinary tract stones since 1980s due to its minimally invasive characters and low morbidity. The overall stone free rates have been reported to be 80% to 90% . In the presence of pregnancy, untreated urinary tract infection, decompensated coagulopathy, uncontrolled arrhythmia and abdominal aortic aneurysm, other treatment methods should be considered . SWL is associated with some complications. The most common complications of SWL are renal colic (40%), gross hematuria (32%), urinary obstruction (30.9%), symptomatic bacteriuria (9.7%) and perirenal hematoma or subclinical subcapsular hematoma (4.6%). There are many factors affecting the success of SWL as patient age, sex, body mass index (BMI), stone size, site and number, radiological renal features, congenital renal anomalies and presence of double-J (DJ) ureteric stent . Regarding the renal stones, stones smaller than 10 mm had a success rate of 90%, while those larger than 10 mm had a success rate of 70%. Stones located in the renal pelvis and upper pole had a success rate of 87.3 and 88.5% respectively, while those located in the lower pole had a success rate of 69.5%. A single renal stone had a 78.3% success rate compared to 62.8% in multiple renal stones . Regarding the ureteric stones, stone size more than 10 mm was one of the strongest independent predictors of failure of SWL Patients appear to have the best chance for successful SWL when they have small BMI and their stones are single and located in the renal pelvis . Skin to stone distance (SSD) measured by non-contrast computerized tomography scan (NCCT) has a significant role in the treatment of renal stones using SWL. Slow shock wave rate (60/min) is associated with increase in the success rate and decrease in pain, complication and number of session to achieve success when compared to rapid shock wave rate (120/min) Some techniques were developed to increase the efficacy of SWL. In 1999, the bidirectional synchronous twin-pulse technique with variable angles between the shock wave reflectors was developed and it improved the quality and rate of stone disintegration in vitro and it was more effective than the traditional single generator and also it decreases the overall treatment times The TWINHEADS 101 lithotripter comprises two identical under and over table reflectors to permit synchronous shock waves emission from two perpendicular directions to the same focal point. This technique intensifies and localizes the cavitations effects by the interacting focal zones of both reflectors, resulting in a better quality and rate of stone disintegration, especially with a right angle between the axes of the reflectors. The first prospective clinical study was done in 2005 regarding synchronous twin-pulse SWL and it seems safe and effective for treating patients with renal and upper ureteric stones. The stone-free rate was 74% after one session and 100% after two sessions within a month Based on the principle of the TWINHEADS lithotripter, we will use Dornier Gemini lithotripter to emit the shock waves from two different directions to the same focal point asynchronously for renal and upper lumbar ureteric stones.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases, Stones, Kidney, Stone, Urinary, Shock Wave Lithotripsy
Keywords
Shock wave lithotripsy, Bidirectional, Stones

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bidirectional Shock Wave Lithotripsy
Arm Type
Active Comparator
Arm Description
alternating bidirectional (under and over table) approach
Arm Title
Standard Shock Wave Lithotripsy
Arm Type
Active Comparator
Arm Description
standard unidirectional approach
Intervention Type
Procedure
Intervention Name(s)
Bidirectional Shock Wave Lithotripsy
Other Intervention Name(s)
Bidirectional SWL
Intervention Description
the alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones
Intervention Type
Procedure
Intervention Name(s)
Standard Shock Wave Lithotripsy
Other Intervention Name(s)
Standard SWL
Intervention Description
the standard unidirectional approach during SWL for renal and upper lumbar ureteric stones
Primary Outcome Measure Information:
Title
stone free rate three months after the last session
Description
residual less than 4 mm by non-contrast computerized tomography scan (NCCT)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
severity of complications after SWL in both groups
Description
Clavien-Dindo scale of surgical complications
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient criteria: Ability to give informed consent. Normal laboratory profile as regarding serum creatinine, liver function, platelets count and prothrombin time. Stone criteria: Single renal stone less than two cm or upper lumbar ureteric stone less than one cm. Radio-opaque stones. Exclusion Criteria: Bleeding tendency. Poor kidney function. Pregnancy. Abdominal aortic aneurysm. Indwelling DJ ureteric stent or percutaneous nephrostomy tube (PCN). Congenital anomalies of the urinary tract. Untreated urinary tract infection. Obstructed urinary tract distal to the stone.
Facility Information:
Facility Name
Urology and Nephrology center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
32206888
Citation
Hegazy M, El-Assmy A, Ali-El-Dein B, Sheir KZ. The alternating bidirectional versus the standard approach during shock wave lithotripsy for upper lumbar ureteric stones: a randomized controlled trial. World J Urol. 2021 Jan;39(1):247-253. doi: 10.1007/s00345-020-03148-5. Epub 2020 Mar 23.
Results Reference
derived

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The Alternating Bidirectional Versus The Standard Approach During Shock Wave Lithotripsy For Renal And Upper Lumbar Ureteric Stones

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