Tubeless vs Tube PCNL in Pediatric Nephrolithiasis: A Randomized Controlled Trial.

NCT ID: NCT07183930

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-09-10

Brief 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.

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.

Conditions

Nephrolithiasis; Kidney Stones; Pediatric Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tubeless 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.

Group Type: EXPERIMENTAL

Tubeless Percutaneous Nephrolithotomy (PCNL)

Intervention Type: PROCEDURE

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.

Tube PCNL

Standard PCNL performed with placement of a nephrostomy tube following stone clearance, along with a double-J stent.

Group Type: ACTIVE_COMPARATOR

Standard Tube Percutaneous Nephrolithotomy (PCNL)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khyber Teaching Hospital

OTHER

Sponsor Role: collaborator

Lady Reading Hospital, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Waseem Ullah

Tariq

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tariq Ahmad, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Khyber Teaching Hospital, Peshawar

Locations

Khyber Teaching Hospital, Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

KMC-IREB-533

Identifier Type: -

Identifier Source: org_study_id