| CTRI Number |
CTRI/2025/08/093921 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [DJ stent placement in cases] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of kidney stone breaking in people with and without DJ stent before the procedure called eswl |
|
Scientific Title of Study
|
Comparison of stone clearance with and without Pre-procedure Double J stenting in patients undergoing Extracorporeal Shock Wave Lithotripsy for Renal and Upper Ureteric Calculi: A Randomised Controlled Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri H |
| Designation |
Postgraduate |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Surgery, Maulana Azad Medical College and Lok Nayak Hospital, Bahadur shah zafar marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9968233257 |
| Fax |
|
| Email |
gauri.h98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anurag Mishra |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
MDepartment of Surgery, aulana Azad Medical College and Lok Nayak Hospital, Bahadur shah zafar marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9899797734 |
| Fax |
|
| Email |
profanuragmamc@mail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gauri H |
| Designation |
Postgraduate |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of surgery, Maulana Azad Medical College and Lok Nayak Hospital, Bahadur shah zafar marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9968233257 |
| Fax |
|
| Email |
gauri.h98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, Near Delhi Gate, New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gauri |
Maulana Azad Medical College and Lok Nayak Hospital |
2, Bahadur shah zafar marg, Near Delhi Gate, New Delhi 110002
Central
DELHI |
9968233257
gauri.h98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College And Associated Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (2) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DJ stent placement |
Participants in Group A will have DJ stent placement.
Both sets of participants will undergo ESWL |
| Comparator Agent |
No DJ stent placement in control group prior to ESWL |
Group B patients act as controls wherein there is no DJ stenting done prior to ESWL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 year.
Stones considered amenable to ESWL.
Solitary stone
Located in kidney and upper ureter
Size less than or equal to 15 mm
CT Hounsefield unit less 1000 |
|
| ExclusionCriteria |
| Details |
Active urinary tract infection
Bleeding diathesis
Pregnancy and lactation
Failed attempt to stenting
Uncontrolled hypertension
Deranged renal function |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stone clearance rate: Proportion of patients with stone clearance after extracorporeal shock wave lithotripsy after max 4 sessions (cycles) of ESWL. New cycle will be repeated after 2 weeks of the previous cycle. Xray kub will be done on post procedure day 3
Stone clearance will be considered successful if the stone is cleared completely or could be fragmented to small (less than 4mm) passable fragments. |
Stone clearance rate: Proportion of patients with stone clearance after extracorporeal shock wave lithotripsy after max 4 sessions (cycles) of ESWL. New cycle will be repeated after 2 weeks of the previous cycle. Xray kub will be done on post procedure day 3
Stone clearance will be considered successful if the stone is cleared completely or could be fragmented to small (less than 4mm) passable fragments. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• ESWL Failure rate: ESWL failure will be labelled if
• Stone clearance is not achieved even after 4 cycles of ESWL
• Patient not tolerating ESWL or chooses another treatment modality
• Complication rate (Percentage of patients)
• Residual stone size following ESWL (in cms)
• No. of sittings of ESWL (in Nos)
• Energy Delivered during ESWL in Joules |
Outcome will be assessed at the end of each cycle on post procedure day 3 & at the end of 4 cycles |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
09/09/2025 |
| 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="0"
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
|
Renal calculi (kidney stones) commonly cause hematuria and flank or groin pain, and arise due to factors like urinary stasis, metabolic imbalances (e.g., hypercalciuria, hyperoxaluria), infections, genetic disorders, and dietary influences. Diagnosis typically involves imaging such as X-rays and non-contrast CT scans. Treatment options include extracorporeal shock wave lithotripsy (ESWL), which is the first-line treatment for many stones due to its non-invasive nature and low complication rate. However, ESWL may sometimes cause complications like obstruction from stone fragments, which can be mitigated by placing a double J stent—though its routine use remains controversial.The study aims to evaluate the efficacy and safety of pre-stenting in improving ESWL outcomes.The study aims to evaluate the effectiveness of pre-procedure double J (DJ) stenting in patients undergoing extracorporeal shock wave lithotripsy (ESWL) for renal and upper ureteric stones. It compares patients with and without stenting based on three key outcomes: Stone clearance rate, Complication rate and Residual stone size
|