NephrolithiasisTUBELESSNCT07183930
Tubeless vs Tube PCNL in Pediatric Nephrolithiasis
A study testing Tubeless Percutaneous Nephrolithotomy (PCNL) and Standard Tube Percutaneous Nephrolithotomy (PCNL) in people with Nephrolithiasis and Pediatric Nephrolithiasis, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
Trial summary
This study is designed to compare two surgical techniques for removing kidney stones in children and adolescents (ages 6-18 years). Both methods are types of percutaneous nephrolithotomy (PCNL), a standard procedure for kidney stones larger than 10 mm. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Nephrolithiasis, Pediatric Nephrolithiasis
- What is being tested?
- Tubeless Percutaneous Nephrolithotomy (PCNL) and Standard Tube Percutaneous Nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6 to 18 years
- Either gender
- Renal calculi larger than 10 mm on imaging
- Failed conservative management or extracorporeal shock wave lithotripsy (ESWL)
- Normal renal function
- Informed consent from parents/guardians
- Assent from children aged 12 years and above
Who cannot join
- Prior renal surgery or ureteral stenting
- Congenital urological anomalies
- Active urinary tract infection at the time of surgery
- Known bleeding disorders or use of anticoagulant medication
- Significant comorbid medical conditions
- Pregnancy (in adolescent females)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber Teaching Hospital, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Comparison Between Tubeless and Tube Percutaneous Nephrolithotomy in Pediatric Population: A Randomized Controlled Trial
This study is designed to compare two surgical techniques for removing kidney stones in children and adolescents (ages 6-18 years). Both methods are types of percutaneous nephrolithotomy (PCNL), a standard procedure for kidney stones larger than 10 mm.
In the traditional method, a temporary tube (nephrostomy tube) is left in the kidney after surgery to drain urine. In the newer "tubeless" method, the tube is not used, and only a small internal stent may be placed. We want to find out if the tubeless method is as safe and effective as the traditional method, and whether it reduces pain, hospital stay, and the need for blood transfusions. The study involves 640 patients at Khyber Teaching Hospital in Peshawar, Pakistan. Each participant is randomly assigned to one of the two techniques.
Read the detailed description
Pediatric kidney stones are increasingly common and often require surgical management when stones are larger than 10 mm or fail to pass with conservative treatment. Percutaneous nephrolithotomy (PCNL) is the gold standard for such cases. Traditionally, PCNL involves the placement of a nephrostomy tube to ensure postoperative drainage. However, this tube can increase discomfort, lengthen hospital stay, and sometimes lead to bleeding.
Recent advances in adult populations suggest that "tubeless" PCNL-where no external drainage tube is left-may reduce postoperative pain, decrease hospital stay, and improve recovery, without compromising safety. Evidence in children remains limited, mostly from small retrospective series.
This randomized controlled trial was conducted at Khyber Teaching Hospital, Peshawar, between October 2024 and March 2025. A total of 640 pediatric patients aged 6-18 years with renal stones >10 mm were randomized into two groups: Group A (Tubeless PCNL, n=320) and Group B (Tube PCNL, n=320). All procedures were performed by a single experienced pediatric urologist using standardized mini-PCNL techniques.
The primary outcomes include operative time, hospital stay, blood transfusion requirement, and stone-free status on discharge. Secondary outcomes include postoperative pain scores, analgesic use, complications (graded by Clavien-Dindo classification), time to resumption of normal activities, and patient/family satisfaction.
By directly comparing the two approaches in a large pediatric cohort, this study provides high-quality evidence to determine whether tubeless PCNL should be considered the preferred technique in appropriately selected children.
- Conditions
- Nephrolithiasis, Pediatric Nephrolithiasis
- Being tested
- Tubeless Percutaneous Nephrolithotomy (PCNL), Standard Tube Percutaneous Nephrolithotomy (PCNL)
- Keywords
- Blood transfusion, Kidney stone surgery, Tubeless PCNL, PCNL, Percutaneous nephrolithotomy, Stone-free rate
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubeless Percutaneous Nephrolithotomy (PCNL)Procedure or surgery
Mini-PCNL with tract dilation up to 18 Fr and stone fragmentation by pneumatic lithotripsy. Following clearance, a double-J stent is placed; no nephrostomy tube is inserted.
Standard Tube Percutaneous Nephrolithotomy (PCNL)Procedure or surgery
Mini-PCNL with tract dilation up to 18 Fr and stone fragmentation by pneumatic lithotripsy. Following clearance, a 14 Fr nephrostomy tube and a double-J stent are placed.
| Study group | Role | What they receive |
|---|---|---|
| Tubeless PCNL | Experimental | Percutaneous nephrolithotomy (PCNL) performed without nephrostomy tube placement. After complete stone clearance and confirmation of hemostasis, only a double-J stent is placed; the access tract is left to seal naturally. Receives: Procedure: Tubeless Percutaneous Nephrolithotomy (PCNL) |
| Tube PCNL | Active comparator | Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent. Receives: Procedure: Standard Tube Percutaneous Nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay (days)
Number of days from the date of surgery until discharge from hospital.
Measured: From surgery to discharge (up to 7 days).
Operative time (minutes)
Duration of the surgical procedure measured from skin incision to skin closure, recorded in minutes.
Measured: During surgery (single procedure).
Blood transfusion requirement (%)
Proportion of participants requiring perioperative blood transfusion, as documented in patient records.
Measured: surgery through hospital discharge (up to 7 days).
Stone-free status (%)
Proportion of patients with no residual stone fragments >2 mm on postoperative imaging (ultrasound or CT).
Measured: At hospital discharge (within 48 hours after surgery).
Secondary outcomes (5)
Postoperative pain score (Visual Analog Scale)
Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse pain. The score will be averaged over the first 24 hours after surgery.
Measured: First 24 hours post-surgery
Analgesic requirement (morphine equivalents, mg)
Total opioid dose used postoperatively in the first 48 hours, converted to morphine equivalents and measured in milligrams.
Measured: First 48 hours post-surgery
Postoperative complications (Clavien-Dindo classification)
Number and severity of complications graded using the Clavien-Dindo classification system.
Measured: surgery to discharge (up to 7 days)
Time to return to normal activity (days)
Number of days from surgery until the patient resumes routine daily activities, as reported by patient/parent.
Measured: Up to 30 days post-surgery
Patient and family satisfaction score
Satisfaction with overall care and outcome, measured using a 10-point Likert scale questionnaire completed at discharge.
Measured: At hospital discharge (within 7 days post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2024
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Reading Hospital, Pakistan
- Sponsor type
- Other government
- Collaborators
- Khyber Teaching Hospital
- Responsible party
- Principal investigator, Dr. Waseem Ullah, Khyber Teaching Hospital
- Investigators
- Tariq Ahmad, MBBS, FCPS, Principal investigator, Khyber Teaching Hospital, Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183930
- Sponsor's protocol ID
- KMC-IREB-533
- Acronym
- TUBELESS
- Status last verified
- Aug 2026
- First submitted
- 13 Sep 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plans have not been finalized. This will depend on journal requirements, funding agency policies, and institutional guidelines at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Tubeless and Tube Percutaneous Nephrolithotomy in Pediatric Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07183930
- Acronym / sponsor ID
- TUBELESS / KMC-IREB-533
- Conditions
- Nephrolithiasis, Pediatric Nephrolithiasis
- Keywords
- Blood transfusion, Kidney stone surgery, Tubeless PCNL, PCNL, Percutaneous nephrolithotomy, Stone-free rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Lady Reading Hospital, PakistanOther government
- Collaborators
- Khyber Teaching Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare two surgical techniques for removing kidney stones in children and adolescents (ages 6-18 years). Both methods are types of percutaneous nephrolithotomy (PCNL), a standard procedure for kidney stones larger than 10 mm.
In the traditional method, a temporary tube (nephrostomy tube) is left in the kidney after surgery to drain urine. In the newer "tubeless" method, the tube is not used, and only a small internal stent may be placed. We want to find out if the tubeless method is as safe and effective as the traditional method, and whether it reduces pain, hospital stay, and the need for blood transfusions. The study involves 640 patients at Khyber Teaching Hospital in Peshawar, Pakistan. Each participant is randomly assigned to one of the two techniques.
Detailed description
Pediatric kidney stones are increasingly common and often require surgical management when stones are larger than 10 mm or fail to pass with conservative treatment. Percutaneous nephrolithotomy (PCNL) is the gold standard for such cases. Traditionally, PCNL involves the placement of a nephrostomy tube to ensure postoperative drainage. However, this tube can increase discomfort, lengthen hospital stay, and sometimes lead to bleeding.
Recent advances in adult populations suggest that "tubeless" PCNL-where no external drainage tube is left-may reduce postoperative pain, decrease hospital stay, and improve recovery, without compromising safety. Evidence in children remains limited, mostly from small retrospective series.
This randomized controlled trial was conducted at Khyber Teaching Hospital, Peshawar, between October 2024 and March 2025. A total of 640 pediatric patients aged 6-18 years with renal stones >10 mm were randomized into two groups: Group A (Tubeless PCNL, n=320) and Group B (Tube PCNL, n=320). All procedures were performed by a single experienced pediatric urologist using standardized mini-PCNL techniques.
The primary outcomes include operative time, hospital stay, blood transfusion requirement, and stone-free status on discharge. Secondary outcomes include postoperative pain scores, analgesic use, complications (graded by Clavien-Dindo classification), time to resumption of normal activities, and patient/family satisfaction.
By directly comparing the two approaches in a large pediatric cohort, this study provides high-quality evidence to determine whether tubeless PCNL should be considered the preferred technique in appropriately selected children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubeless PCNL | Experimental | Procedure: Tubeless Percutaneous Nephrolithotomy (PCNL)Percutaneous nephrolithotomy (PCNL) performed without nephrostomy tube placement. After complete stone clearance and confirmation of hemostasis, only a double-J stent is placed; the access tract is left to seal naturally. |
| Tube PCNL | Active comparator | Procedure: Standard Tube Percutaneous Nephrolithotomy (PCNL)Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children aged 6 to 18 years
- Either gender
- Renal calculi larger than 10 mm on imaging
- Failed conservative management or extracorporeal shock wave lithotripsy (ESWL)
- Normal renal function
Key exclusion criteria (6 listed)
- Prior renal surgery or ureteral stenting
- Congenital urological anomalies
- Active urinary tract infection at the time of surgery
- Known bleeding disorders or use of anticoagulant medication
- Significant comorbid medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tubeless Percutaneous Nephrolithotomy (PCNL)Mini-PCNL with tract dilation up to 18 Fr and stone fragmentation by pneumatic lithotripsy. Following clearance, a double-J stent is placed; no nephrostomy tube is inserted. | Procedure or surgery | Tubeless PCNL |
| Standard Tube Percutaneous Nephrolithotomy (PCNL)Mini-PCNL with tract dilation up to 18 Fr and stone fragmentation by pneumatic lithotripsy. Following clearance, a 14 Fr nephrostomy tube and a double-J stent are placed. | Procedure or surgery | Tube PCNL |
Primary outcome
Length of hospital stay (days)
Time frame: From surgery to discharge (up to 7 days).
Number of days from the date of surgery until discharge from hospital.
Operative time (minutes)
Time frame: During surgery (single procedure).
Duration of the surgical procedure measured from skin incision to skin closure, recorded in minutes.
Blood transfusion requirement (%)
Time frame: surgery through hospital discharge (up to 7 days).
Proportion of participants requiring perioperative blood transfusion, as documented in patient records.
Stone-free status (%)
Time frame: At hospital discharge (within 48 hours after surgery).
Proportion of patients with no residual stone fragments >2 mm on postoperative imaging (ultrasound or CT).
5 secondary outcomes
Postoperative pain score (Visual Analog Scale)
Time frame: First 24 hours post-surgery
Analgesic requirement (morphine equivalents, mg)
Time frame: First 48 hours post-surgery
Postoperative complications (Clavien-Dindo classification)
Time frame: surgery to discharge (up to 7 days)
Time to return to normal activity (days)
Time frame: Up to 30 days post-surgery
Patient and family satisfaction score
Time frame: At hospital discharge (within 7 days post-surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided. Data sharing plans have not been finalized. This will depend on journal requirements, funding agency policies, and institutional guidelines at the time of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tariq Ahmad, MBBS, FCPS principal investigator
Khyber Teaching Hospital, Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubeless Percutaneous Nephrolithotomy (PCNL) and Standard Tube Percutaneous Nephrolithotomy (PCNL) in people with Nephrolithiasis and Pediatric Nephrolithiasis, run by Lady Reading Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (days) (time frame: From surgery to discharge (up to 7 days).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.