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CTRI Number  CTRI/2025/08/092760 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing ultrasound guidance and X-ray guidance for kidney stone removal surgery to find out which method removes stones more effectively and safely 
Scientific Title of Study   A Randomized Controlled Trial Comparing Ultrasound Versus Fluoroscopy Guided Percutaneous Nephrolithotomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Nirmalya Ghosh 
Designation  Associate Professor 
Affiliation  AIIMS Kalyani 
Address  Room No.448,4th floor OPD Block Department of Urology AIIMS Kalyani.

Nadia
WEST BENGAL
741245
India 
Phone  8622006866  
Fax    
Email  nirmalya.urol@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Nirmalya Ghosh 
Designation  Associate Professor 
Affiliation  AIIMS Kalyani 
Address  Room No.448,4th floor OPD Block Department of Urology AIIMS Kalyani.

Nadia
WEST BENGAL
741245
India 
Phone  8622006866  
Fax    
Email  nirmalya.urol@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Kovarthanan P 
Designation  Academic Senior Resident 
Affiliation  AIIMS Kalyani 
Address  Room No.448,4th floor OPD Block Department of Urology AIIMS Kalyani.

Nadia
WEST BENGAL
741245
India 
Phone  9789272296  
Fax    
Email  kovarthanan.urol_acsr25@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Kalyani 
Address  NH-34 Connector, Basantapur,Saguna West Bengal- 741245 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kovarthanan P  AIIMS Kalyani  Room No.448,4th floor Department of Urology.
Nadia
WEST BENGAL 		 09789272296

kovarthanan.urol_acsr25@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoroscopy Guided Percutaneous Nephrolithotomy  Renal Access and Tract Dilatation Guided By Fluoroscopic Imaging During Percutaneous Nephrolithotomy 
Intervention  Ultrasound Guided Percutaneous Nephrolithotomy  Renal Access and Tract Dilatation Guided Entirely By Real-Time Ultrasound Imaging For Percutaneous Nephrolithotomy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with renal calculi size more than or equal to 2 cm.
Patients with lower pole calculi more than or equal to 1 cm.
Patients with staghorn calculus.
 
 
ExclusionCriteria 
Details  Paediatric age group.
Urinary tract Anomalies like Horseshoe kidney, Crossed ectopic kidney and Fused ectopic kidney.
Uncorrected bleeding disorders or Coagulopathies.
Active urinary tract infection at time of surgery.
Post renal transplant.
Pregnancy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the calyceal puncture time, tract dilatation time and stone-free status between ultrasound-guided and fluoroscopic-guided PCNL  inta-op, intra-op, intra-op and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Radiation exposure time,
Evaluation of safety profile- Bleeding and Infection 		 Radiation exposure time- Measured intraoperatively in seconds,
Bleeding - Postoperatively on day 1 with Hemoglobin drop from baseline,
Infection - Until hospital discharge or within 30 days from surgery. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a single center, prospective, randomized controlled trial comparing ultrasound guided versus fluoroscopy guided Percutaneous Nephrolithotomy in patients falling under inclusion criteia.The study aims to evaluate intraoperative parameters like Calyceal puncture time, tract dilatation time and stone free status, as well as secondary outcomes such as radiation exposure time, complications like bleeding, infection.Patients will be randomly assigned to either Group A or Group B with all the other surgical tips standardized.
Hypothesis of the study is that ultrasound guided Percutaneous Nephrolithotomy is non inferior to fluoroscopic guided Percutaneous Nephrolithotomy in terms of stone free status and radiation exposure time.
 
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