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Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SWL
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Between January 2016 and December 2017, a total of 152 adult (age > 18 years) patients who were planned to undergo ESWL for a single radiopaque renal pelvic stone with a largest diameter of 15 to 25 mm were included in the study.

-

Exclusion Criteria:

  • Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, HN (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    jj stent yes

    jj stent no

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients, who have JJ stent or not, with successful SWL treatment.
    Number of patients, who have JJ stent or not, with successful SWL treatment which assessed after 3 months following the last SWL session.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2018
    Last Updated
    August 15, 2018
    Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03636516
    Brief Title
    Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy
    Official Title
    Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy Treatment of Moderate Sized Renal Pelvic Stones: A Randomized Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    December 30, 2017 (Actual)
    Study Completion Date
    December 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital

    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
    Background: Many studies showed that stone-free rates (SFRs) after extracorporeal shock wave lithotripsy (SWL) might be related to both the patient (body mass index; BMI, skin-to-stone distance; SSD), and stone related factors (location, stone size, and stone density). However, the possible effect of pre-stenting on success as well as complication rates after SWL has not been evaluated in detail to date. Taking this fact into account, the effect of pre-stenting on the outcomes of SWL treatment in renal stones must be evaluated in the absence of possible effects induced by the patient and stone-related factors. Aim: To evaluate the effect of double J (JJ) stents on SWL treatment of moderate sized (15-25-mm) renal pelvic stones. Study design: Randomized prospective study Methods: Between January 2016 and December 2017, a total of 152 adult patients who were planned to undergo SWL for a single radiopaque renal pelvic stone were included in the study. Patients with solitary kidney, congenital abnormality, skeletal tract abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded. The remaining 114 patients were randomly divided into two groups; nonstented and stented. Twenty-two patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis.
    Detailed Description
    Study design Between January 2016 and December 2017, a total of 152 adult (age > 18 years) patients who were planned to undergo extracorporeal shock wave lithotripsy (SWL) for a single radiopaque renal pelvic stone with a largest diameter of 15 to 25 mm were included in the study. Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, hydronephrosis (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study. The remaining 114 patients were randomly divided into two groups as non-stented (n=67) and stented (n=47). Randomization was performed by flipping a coin. During SWL procedures, 22 patients whose stone could not be fragmented despite 3 consecutive sessions were also excluded from the study. A total of 92 patients (54 non-stented and 38 stented) were included in the final analysis. Preprocedural evaluation All patients were evaluated preoperatively using non-contrast computed tomography (CT). Prior to treatment, a complete urine test, if needed urine culture and antibiogram test, simple serum biochemistry and coagulation tests were performed in all patients. The impact of patient-related factors (age, sex, body mass index;BMI), stone-related factors (laterality, stone size and Hounsfield units; HU), renal parenchymal thickness (RPT), and skin-to-stone distance (SSD) on fragmentation were analyzed. Body mass index (BMI) was calculated by dividing the weight (kg) by the square of the height (m2). CT with 5-mm contiguous sections at 120 kw and 90 milliampere (mA) was performed in all patients using a multidetector row helical CT scanner (Somatom Plus; Siemens, Germany). The longitudinal stone dimension was calculated by multiplying collimation thickness and the number of images in which the stone seen. The transverse dimension was chosen as the diameter of stone from the image showing its largest width. The maximum dimension of the stone was accepted as the highest value measured, either the longitudinal or transverse diameter. The average CT attenuation value as the representative HU was measured by drawing a region of interest smaller than the stone in the image showing the stone in the largest dimension. The SSD was calculated by measuring the distance from the skin to the stone at posterolateral 45°. All patients signed an informed consent form for SWL and pre-stenting. Stent size was 4.8 French and 26 cm. SWL technique SWL was performed with an electromagnetic lithotripter Compact Sigma (Dornier Med Tech System Gesellschaft mit beschränkter Haftung; GmbH, Weßling, Germany) by the same operator, with the patient in the supine position, and with a standardized treatment angle under both fluoroscopic and ultrasonic guidance. SWL procedures were performed with analgesic application (75 mg diclofenac sodium). If needed, a compression bag was used to decrease stone movement caused by respiration. Each session was completed either after application of a total of 3000 shock waves or when the stone was completely disintegrated. The degree of shock wave power delivered during SWL was recorded as 1 to 6 and the shock wave frequency was 90/minute. Individual power settings were adjusted according to the patient's tolerance. Patients were evaluated 1 week after each session through abdominal kidneys, ureters, and urinary bladder (KUB) X-ray and repeat treatment was performed in cases of inadequate disintegration. Management was stopped when there was no disintegration despite 3 SWL sessions. No patients received medical expulsive treatment (MET) before or after SWL sessions. JJ stents were removed after 4 weeks. In view of the radiographic assessment with CT performed 4 months following the last SWL session, treatment results were categorized as either successful or unsuccessful according to whether there were any residual stone fragments. During SWL sessions and after treatment, the number of emergency department visits and analgesic consumption were recorded. Statistical analysis Data were analyzed using the Statistical Package for the Social Sciences software version 19 (SPSS Inc., Chicago, Illinois, USA). Descriptive statistics were determined for the mean, standard deviation, lowest and highest, and ratio values. The distribution of the variables was measured using the Kolmogorov-Smirnov test. Univariate (Chi-square or t-test) tests were performed to determine whether there was a statistically significant difference for characteristics between the stented and non-stented groups. If parameters did not show normal dispersion, the Mann-Whitney U test, which is the nonparametric equivalent of the t-test, was performed. The threshold for statistical significance was accepted as p < 0.05 for all analyses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urolithiasis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    jj stent yes
    Arm Type
    Active Comparator
    Arm Title
    jj stent no
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    SWL
    Intervention Description
    extracorporeal shockwave lithotripsy apply
    Primary Outcome Measure Information:
    Title
    Number of patients, who have JJ stent or not, with successful SWL treatment.
    Description
    Number of patients, who have JJ stent or not, with successful SWL treatment which assessed after 3 months following the last SWL session.
    Time Frame
    15 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:Between January 2016 and December 2017, a total of 152 adult (age > 18 years) patients who were planned to undergo ESWL for a single radiopaque renal pelvic stone with a largest diameter of 15 to 25 mm were included in the study. - Exclusion Criteria: Patients with solitary kidneys, congenital abnormalities, skeletal system abnormalities, previous urinary system surgery, HN (grade 2 or more), untreated urinary tract infection, bleeding disorder, and suspected pregnancy were excluded from the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Double J Stent on Outcomes of Extracorporeal Shock Wave Lithotripsy

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