<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03307096</url>
  </required_header>
  <id_info>
    <org_study_id>NBDYYY2017003</org_study_id>
    <nct_id>NCT03307096</nct_id>
  </id_info>
  <brief_title>Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS</brief_title>
  <official_title>Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ningbo No. 1 Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Renmin Hospital of Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Hebei University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangsu Province Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Anshun City of Guizhou Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Shenyang Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ningbo No. 1 Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospect, randomized control trial to evaluate merits between microperc and FURS&#xD;
      for lower pole renal stone&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the merits of Microperc and RIRS for the treatment for lower pole renal stone&#xD;
      between 10-20 mm. Investigators will do a multi-centers randomized controlled trial(RCT). A&#xD;
      total of 200 (three hundred) patients, aging between 18 and 60 years are being planned to be&#xD;
      enrolled into the study; By simple random sampling technique, patients will be prospectively&#xD;
      randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc&#xD;
      surgery and group B will undergo FURS.&#xD;
&#xD;
      All the patients will be diagnosed definitely before operations with non-contrast CT+IVP or&#xD;
      CTU, lower pole Infundibular length, Infundibular width and Lower pole infundibulopelvic&#xD;
      angle were recorded. A double J stent will be inserted in two the relevant ureter two weeks&#xD;
      before surgery to guarantee the successful of operations. Patience will receive either&#xD;
      microperic or FURS respectively, The operation time , hemoglobin change, renal function,&#xD;
      post-operation pain, complications and hospital stay will be recorded. Patience will have&#xD;
      follow-up visits at one month and three months, CT and KUB will be taken to evaluate the&#xD;
      clearance of renal stone.&#xD;
&#xD;
      Surgical technique Microperc surgery: After the satisfaction of anesthesia, Patient is turned&#xD;
      into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic&#xD;
      or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be&#xD;
      used to break stone into less than 2mm. Pull out microperc without drainage tube left; RIRS:&#xD;
      After the satisfaction of anesthesia, the patient is placed in the lithotomy position, pull&#xD;
      out the pre-inserted double J stent, and place guidewire into the renal pelvis. A 12/14 Fr&#xD;
      ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and&#xD;
      flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm&#xD;
      using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone&#xD;
      analysis if necessary, a double J stent is placed at the conclusion of the procedure and&#xD;
      removed post-operative 2 weeks.&#xD;
&#xD;
      Data collection Data for the 2 groups-demographic characteristics, hemoglobin(HB) decrease,&#xD;
      white blood cell(WBC) increase, postoperative pain, duration of postoperative hospital stay,&#xD;
      complications (modified Clavien system), stone clearance (SFR) and the need for auxiliary&#xD;
      treatment are compared.&#xD;
&#xD;
      Mean study endpoint: Final SFR (3 months after procedure) Secondary endpoint: Complications,&#xD;
      duration of postoperative hospital stay. re-microperc, ureteroscopy and SWL are considered as&#xD;
      auxiliary treatments.&#xD;
&#xD;
      The stone size is defined as the maximum diameter as determined by CT scans. Degree of&#xD;
      hydronephrosis are assigned as follow: none (no calyx or pelvic dilation), mild (pelvic&#xD;
      dilatation alone), moderate (mild calyx dilation), or severe (severe calyx dilation or calyx&#xD;
      dilation accompanied by renal parenchyma atrophy).&#xD;
&#xD;
      Definition of operation time:&#xD;
&#xD;
      For microperc: recorded from the time of the first percutaneous renal puncture to pulling out&#xD;
      the microperc.&#xD;
&#xD;
      For RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent&#xD;
      placement.&#xD;
&#xD;
      Hospital stay are rounded to the nearest whole day and calculated from the day of surgery to&#xD;
      the day of discharge.&#xD;
&#xD;
      Postoperative pain (visual analogue scale(VAS), use of analgesics) will be recorded.&#xD;
&#xD;
      The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with&#xD;
      24-hour postoperative Hb level.&#xD;
&#xD;
      Non-contrast CT and KUB is obtained for all patients at 3 month after the operation to&#xD;
      evaluate the final SFR, allowing time for the spontaneous passage of stone fragments.&#xD;
&#xD;
      Stone-free status are defined as either the absence of any residual stone fragments or the&#xD;
      presence of clinically insignificant residual stone fragments in the kidney which were&#xD;
      defined as ≤4mm, asymptomatic, non-obstructive and non-infectious stone particles.&#xD;
&#xD;
      Complications of all patients are recorded according to modified Clavien classification&#xD;
      system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">November 17, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>A total of 200 patients, aging between 18 and 60 years are enrolled into the study, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SFR</measure>
    <time_frame>3 month</time_frame>
    <description>Stone free Rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>3 month</time_frame>
    <description>Complications after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of postoperative hospital stay</measure>
    <time_frame>7 days</time_frame>
    <description>Duration of postoperative hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>3 month</time_frame>
    <description>Postoperative pain,visual analogue scale(VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of hemoglobin decrease</measure>
    <time_frame>7 days</time_frame>
    <description>The rate of hemoglobin decrease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation time</measure>
    <time_frame>12 hours</time_frame>
    <description>Operation time of surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Surgery--Complications</condition>
  <condition>Renal Calculus</condition>
  <condition>Nephrolithiasis</condition>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Microperc surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FURS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient is placed in the lithotomy position, pull out the pre-inserted double J, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Microperc surgery</intervention_name>
    <description>Parents are treated by Microperc Percutaneous Nephrolithotomy</description>
    <arm_group_label>Microperc surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FURS</intervention_name>
    <description>Parents are treated by FURS</description>
    <arm_group_label>FURS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 10-20mm lower pole renal stone measured by KUB or CT;&#xD;
&#xD;
          2. Age between 18-60 years, no gender limitation;&#xD;
&#xD;
          3. Participators can understand the research and sign the consent form without mental&#xD;
             illness nor language disorder;&#xD;
&#xD;
          4. Low pole renal stone left after lithotripsy;&#xD;
&#xD;
          5. Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30&#xD;
             degree;&#xD;
&#xD;
          6. Asymptomatic patients with positive urine white blood cells and negative preoperative&#xD;
             urine culture should be treated with antibiotics for 3days before operation;&#xD;
&#xD;
          7. Patients with symptoms of urinary infections, positive urine withe blood cells and&#xD;
             positive preoperative urine culture should be treated with suitable antibiotics based&#xD;
             on the culture sensitivity result for at least 7days before operation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Transplant kidney stone;&#xD;
&#xD;
          2. Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney,&#xD;
             horseshoe kidney, etc.;&#xD;
&#xD;
          3. Combine other part of urinary stones need to be handle at the same procedure, for&#xD;
             example ureteral stone, renal pelvic stone, middle or upper pole renal stone;&#xD;
&#xD;
          4. Hematological Disease or Coagulation disorders;&#xD;
&#xD;
          5. Withdraw anticoagulant medicine less than two weeks;&#xD;
&#xD;
          6. Fever or urinary infections without treatment according to the inclusion criteria;&#xD;
&#xD;
          7. Sevier renal dysfunction(endogenous creatinine clearance rate≤50ml/min)&#xD;
&#xD;
          8. Middle or severe hydronephrosis(dilatation of the renal pelvis ≥20mm by ultrasound);&#xD;
&#xD;
          9. Women in menstrual period or pregnancy;&#xD;
&#xD;
         10. Patients have severe disease, such as heart disease, lung dysfunction, and multiple&#xD;
             organ failure that cannot tolerate anesthesia or operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yue Cheng, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ningbo No. 1 Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yue Cheng, Dr.</last_name>
    <phone>13586689920</phone>
    <email>dongbaba8@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Fnag, Dr.</last_name>
    <phone>17757461299</phone>
    <email>fanyuro@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ningbo NO.1 hospital</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liemin Ruan, MD</last_name>
      <phone>0086057487085111</phone>
    </contact>
    <contact_backup>
      <last_name>Zhongze Lou, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sener NC, Imamoglu MA, Bas O, Ozturk U, Goktug HN, Tuygun C, Bakirtas H. Prospective randomized trial comparing shock wave lithotripsy and flexible ureterorenoscopy for lower pole stones smaller than 1 cm. Urolithiasis. 2014 Apr;42(2):127-31. doi: 10.1007/s00240-013-0618-z. Epub 2013 Nov 13.</citation>
    <PMID>24220692</PMID>
  </reference>
  <reference>
    <citation>Ozgur Tan M, Irkilata L, Sen I, Onaran M, Kupeli B, Karaoglan U, Bozkirli I. The impact of radiological anatomy in clearance of lower caliceal stones after shock wave lithotripsy. Urol Res. 2007 Jun;35(3):143-7. doi: 10.1007/s00240-007-0093-5. Epub 2007 Apr 20.</citation>
    <PMID>17447057</PMID>
  </reference>
  <reference>
    <citation>Juan YS, Chuang SM, Wu WJ, Shen JT, Wang CJ, Huang CH. Impact of lower pole anatomy on stone clearance after shock wave lithotripsy. Kaohsiung J Med Sci. 2005 Aug;21(8):358-64. doi: 10.1016/S1607-551X(09)70134-2.</citation>
    <PMID>16158878</PMID>
  </reference>
  <reference>
    <citation>Turk C. [Urolithiasis guidelines: retrospective view and perspectives]. Urologe A. 2016 Oct;55(10):1317-1320. doi: 10.1007/s00120-016-0230-2. German.</citation>
    <PMID>27604704</PMID>
  </reference>
  <reference>
    <citation>Molina WR, Kim FJ, Spendlove J, Pompeo AS, Sillau S, Sehrt DE. The S.T.O.N.E. Score: a new assessment tool to predict stone free rates in ureteroscopy from pre-operative radiological features. Int Braz J Urol. 2014 Jan-Feb;40(1):23-9. doi: 10.1590/S1677-5538.IBJU.2014.01.04.</citation>
    <PMID>24642147</PMID>
  </reference>
  <reference>
    <citation>Elbahnasy AM, Clayman RV, Shalhav AL, Hoenig DM, Chandhoke P, Lingeman JE, Denstedt JD, Kahn R, Assimos DG, Nakada SY. Lower-pole caliceal stone clearance after shockwave lithotripsy, percutaneous nephrolithotomy, and flexible ureteroscopy: impact of radiographic spatial anatomy. J Endourol. 1998 Apr;12(2):113-9. doi: 10.1089/end.1998.12.113.</citation>
    <PMID>9607435</PMID>
  </reference>
  <results_reference>
    <citation>Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the &quot;resorlu-unsal stone score&quot;. Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.</citation>
    <PMID>22840867</PMID>
  </results_reference>
  <results_reference>
    <citation>Kilicarslan H, Kaynak Y, Kordan Y, Kaygisiz O, Coskun B, Gunseren KO, Kanat FM. Unfavorable anatomical factors influencing the success of retrograde intrarenal surgery for lower pole renal calculi. Urol J. 2015 Apr 29;12(2):2065-8.</citation>
    <PMID>25923149</PMID>
  </results_reference>
  <results_reference>
    <citation>Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.</citation>
    <PMID>21855968</PMID>
  </results_reference>
  <results_reference>
    <citation>Inoue T, Murota T, Okada S, Hamamoto S, Muguruma K, Kinoshita H, Matsuda T; SMART Study Group. Influence of Pelvicaliceal Anatomy on Stone Clearance After Flexible Ureteroscopy and Holmium Laser Lithotripsy for Large Renal Stones. J Endourol. 2015 Sep;29(9):998-1005. doi: 10.1089/end.2015.0071. Epub 2015 May 15.</citation>
    <PMID>25879676</PMID>
  </results_reference>
  <results_reference>
    <citation>Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.</citation>
    <PMID>23826843</PMID>
  </results_reference>
  <results_reference>
    <citation>Karatag T, Tepeler A, Silay MS, Bodakci MN, Buldu I, Daggulli M, Hatipoglu NK, Istanbulluoglu MO, Armagan A. A Comparison of 2 Percutaneous Nephrolithotomy Techniques for the Treatment of Pediatric Kidney Stones of Sizes 10-20 mm: Microperc vs Miniperc. Urology. 2015 May;85(5):1015-1018. doi: 10.1016/j.urology.2015.02.010.</citation>
    <PMID>25917724</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>November 16, 2017</last_update_submitted>
  <last_update_submitted_qc>November 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ningbo No. 1 Hospital</investigator_affiliation>
    <investigator_full_name>Li Fang</investigator_full_name>
    <investigator_title>Urologist</investigator_title>
  </responsible_party>
  <keyword>FURS</keyword>
  <keyword>microperc</keyword>
  <keyword>renal calculus</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Retrograde Intrarenal Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307096
org study id: NBDYYY2017003
nct id: NCT03307096
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospect, randomized control trial to evaluate merits between microperc and FURS
      for lower pole renal stone
To evaluate the merits of Microperc and RIRS for the treatment for lower pole renal stone
      between 10-20 mm. Investigators will do a multi-centers randomized controlled trial(RCT). A
      total of 200 (three hundred) patients, aging between 18 and 60 years are being planned to be
      enrolled into the study; By simple random sampling technique, patients will be prospectively
      randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc
      surgery and group B will undergo FURS.

      All the patients will be diagnosed definitely before operations with non-contrast CT+IVP or
      CTU, lower pole Infundibular length, Infundibular width and Lower pole infundibulopelvic
      angle were recorded. A double J stent will be inserted in two the relevant ureter two weeks
      before surgery to guarantee the successful of operations. Patience will receive either
      microperic or FURS respectively, The operation time , hemoglobin change, renal function,
      post-operation pain, complications and hospital stay will be recorded. Patience will have
      follow-up visits at one month and three months, CT and KUB will be taken to evaluate the
      clearance of renal stone.

      Surgical technique Microperc surgery: After the satisfaction of anesthesia, Patient is turned
      into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic
      or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be
      used to break stone into less than 2mm. Pull out microperc without drainage tube left; RIRS:
      After the satisfaction of anesthesia, the patient is placed in the lithotomy position, pull
      out the pre-inserted double J stent, and place guidewire into the renal pelvis. A 12/14 Fr
      ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and
      flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm
      using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone
      analysis if necessary, a double J stent is placed at the conclusion of the procedure and
      removed post-operative 2 weeks.

      Data collection Data for the 2 groups-demographic characteristics, hemoglobin(HB) decrease,
      white blood cell(WBC) increase, postoperative pain, duration of postoperative hospital stay,
      complications (modified Clavien system), stone clearance (SFR) and the need for auxiliary
      treatment are compared.

      Mean study endpoint: Final SFR (3 months after procedure) Secondary endpoint: Complications,
      duration of postoperative hospital stay. re-microperc, ureteroscopy and SWL are considered as
      auxiliary treatments.

      The stone size is defined as the maximum diameter as determined by CT scans. Degree of
      hydronephrosis are assigned as follow: none (no calyx or pelvic dilation), mild (pelvic
      dilatation alone), moderate (mild calyx dilation), or severe (severe calyx dilation or calyx
      dilation accompanied by renal parenchyma atrophy).

      Definition of operation time:

      For microperc: recorded from the time of the first percutaneous renal puncture to pulling out
      the microperc.

      For RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent
      placement.

      Hospital stay are rounded to the nearest whole day and calculated from the day of surgery to
      the day of discharge.

      Postoperative pain (visual analogue scale(VAS), use of analgesics) will be recorded.

      The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with
      24-hour postoperative Hb level.

      Non-contrast CT and KUB is obtained for all patients at 3 month after the operation to
      evaluate the final SFR, allowing time for the spontaneous passage of stone fragments.

      Stone-free status are defined as either the absence of any residual stone fragments or the
      presence of clinically insignificant residual stone fragments in the kidney which were
      defined as ≤4mm, asymptomatic, non-obstructive and non-infectious stone particles.

      Complications of all patients are recorded according to modified Clavien classification
      system.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A total of 200 patients, aging between 18 and 60 years are enrolled into the study, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: SFR
time frame: 3 month
description: Stone free Rate
measure: Complications
time frame: 3 month
description: Complications after surgery
measure: Duration of postoperative hospital stay
time frame: 7 days
description: Duration of postoperative hospital stay
measure: Postoperative pain
time frame: 3 month
description: Postoperative pain,visual analogue scale(VAS)
measure: The rate of hemoglobin decrease
time frame: 7 days
description: The rate of hemoglobin decrease
measure: Operation time
time frame: 12 hours
description: Operation time of surgery
arm group label: Microperc surgery
arm group type: Experimental
description: Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left.
arm group label: FURS
arm group type: Active Comparator
description: Patient is placed in the lithotomy position, pull out the pre-inserted double J, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 4 weeks.
intervention type: Procedure
intervention name: Microperc surgery
description: Parents are treated by Microperc Percutaneous Nephrolithotomy
arm group label: Microperc surgery
intervention type: Procedure
intervention name: FURS
description: Parents are treated by FURS
arm group label: FURS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yue Cheng, Dr.
role: Principal Investigator
affiliation: Ningbo No. 1 Hospital
last name: Yue Cheng, Dr.
phone: 13586689920
email: dongbaba8@hotmail.com
last name: Li Fnag, Dr.
phone: 17757461299
email: fanyuro@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Sener NC, Imamoglu MA, Bas O, Ozturk U, Goktug HN, Tuygun C, Bakirtas H. Prospective randomized trial comparing shock wave lithotripsy and flexible ureterorenoscopy for lower pole stones smaller than 1 cm. Urolithiasis. 2014 Apr;42(2):127-31. doi: 10.1007/s00240-013-0618-z. Epub 2013 Nov 13.
PMID: 24220692
citation: Ozgur Tan M, Irkilata L, Sen I, Onaran M, Kupeli B, Karaoglan U, Bozkirli I. The impact of radiological anatomy in clearance of lower caliceal stones after shock wave lithotripsy. Urol Res. 2007 Jun;35(3):143-7. doi: 10.1007/s00240-007-0093-5. Epub 2007 Apr 20.
PMID: 17447057
citation: Juan YS, Chuang SM, Wu WJ, Shen JT, Wang CJ, Huang CH. Impact of lower pole anatomy on stone clearance after shock wave lithotripsy. Kaohsiung J Med Sci. 2005 Aug;21(8):358-64. doi: 10.1016/S1607-551X(09)70134-2.
PMID: 16158878
citation: Turk C. [Urolithiasis guidelines: retrospective view and perspectives]. Urologe A. 2016 Oct;55(10):1317-1320. doi: 10.1007/s00120-016-0230-2. German.
PMID: 27604704
citation: Molina WR, Kim FJ, Spendlove J, Pompeo AS, Sillau S, Sehrt DE. The S.T.O.N.E. Score: a new assessment tool to predict stone free rates in ureteroscopy from pre-operative radiological features. Int Braz J Urol. 2014 Jan-Feb;40(1):23-9. doi: 10.1590/S1677-5538.IBJU.2014.01.04.
PMID: 24642147
citation: Elbahnasy AM, Clayman RV, Shalhav AL, Hoenig DM, Chandhoke P, Lingeman JE, Denstedt JD, Kahn R, Assimos DG, Nakada SY. Lower-pole caliceal stone clearance after shockwave lithotripsy, percutaneous nephrolithotomy, and flexible ureteroscopy: impact of radiographic spatial anatomy. J Endourol. 1998 Apr;12(2):113-9. doi: 10.1089/end.1998.12.113.
PMID: 9607435
citation: Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
PMID: 22840867
citation: Kilicarslan H, Kaynak Y, Kordan Y, Kaygisiz O, Coskun B, Gunseren KO, Kanat FM. Unfavorable anatomical factors influencing the success of retrograde intrarenal surgery for lower pole renal calculi. Urol J. 2015 Apr 29;12(2):2065-8.
PMID: 25923149
citation: Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
PMID: 21855968
citation: Inoue T, Murota T, Okada S, Hamamoto S, Muguruma K, Kinoshita H, Matsuda T; SMART Study Group. Influence of Pelvicaliceal Anatomy on Stone Clearance After Flexible Ureteroscopy and Holmium Laser Lithotripsy for Large Renal Stones. J Endourol. 2015 Sep;29(9):998-1005. doi: 10.1089/end.2015.0071. Epub 2015 May 15.
PMID: 25879676
citation: Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.
PMID: 23826843
citation: Karatag T, Tepeler A, Silay MS, Bodakci MN, Buldu I, Daggulli M, Hatipoglu NK, Istanbulluoglu MO, Armagan A. A Comparison of 2 Percutaneous Nephrolithotomy Techniques for the Treatment of Pediatric Kidney Stones of Sizes 10-20 mm: Microperc vs Miniperc. Urology. 2015 May;85(5):1015-1018. doi: 10.1016/j.urology.2015.02.010.
PMID: 25917724
responsible party type: Principal Investigator
investigator affiliation: Ningbo No. 1 Hospital
investigator full name: Li Fang
investigator title: Urologist
mesh term: Urolithiasis
mesh term: Nephrolithiasis
mesh term: Kidney Calculi
mesh term: Calculi
sharing ipd: Undecided