NCT02519634

Brief Summary

Shock wave lithotripsy (SWL) is recommended for kidney stones \< 20 mm. However, the stone clearance of lower pole calculi after SWL is limited, thus leading to an extended indication for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments. However, this issue remains controversial. On the other hand, improvements in endoscopy technology have made retrograde stone removal more attractive. This has led to an increasing use of RIRS as a primary treatment although it is recommended only as 2nd-line option by current guidelines. However, the treatment of symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates. The purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

August 3, 2015

Last Update Submit

March 30, 2020

Conditions

Renal Calculi

Keywords

Super-Mini Percutaneous NephrolithotomySMPRetrograde Intrarenal SurgeryRIRSRandomized Controlled TrialRCT

Outcome Measures

Primary Outcomes (1)

  • Stone free rate (SFR)

    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 ≦ 3mm, asymptomatic, non-obstructive and non-infectious stone particles.

    The primary endpoint was the SFR at 3-months after surgery.

Secondary Outcomes (2)

  • Perioperative complications

    intraoperatively or ≤ 3 month postoperatively

  • Operation time

    intraoperatively

Study Arms (2)

Group 1

OTHER

Patients in Group 1 undergo Super-Mini Percutaneous Nephrolithotomy

Procedure: Super-Mini Percutaneous Nephrolithotomy

Group 2

OTHER

Patients in Group 2 undergo Retrograde Intrarenal Surgery

Procedure: Retrograde Intrarenal Surgery

Interventions

Super-Mini Percutaneous NephrolithotomyPROCEDURE

Patients undergo Super-Mini Percutaneous Nephrolithotomy

Group 1
Retrograde Intrarenal SurgeryPROCEDURE

Patients undergo Retrograde Intrarenal Surgery

Group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 70 years
  • Normal renal function
  • Anesthesia rating(ASA) score 1 and 2
  • Absence of congenital abnormalities
  • Symptomatic lower pole calculi and diameter 10-20 mm

You may not qualify if:

  • Patients with solitary kidney
  • Patients with congenital anomalies, e.g. ectopic kidney, polycystic horseshoe, or mal-rotated kidney
  • Patients who underwent transplant or urinary diversion
  • Uncorrected coagulopathy and active urinary tract infection(UTI)
  • Patient undergoing any other surgical procedure during the same admission. (e.g. ureteroscopy)
  • If patients undergoing RIRS/SMP have purulent urine, we will place D-J stent (for RIRS) or nephrostomy tube (for SMP) and postpone the procedure and excluded the patients from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

Related Publications (1)

  • Zeng G, Zhang T, Agrawal M, He X, Zhang W, Xiao K, Li H, Li X, Xu C, Yang S, de la Rosette JJ, Fan J, Zhu W, Sarica K. Super-mini percutaneous nephrolithotomy (SMP) vs retrograde intrarenal surgery for the treatment of 1-2 cm lower-pole renal calculi: an international multicentre randomised controlled trial. BJU Int. 2018 Dec;122(6):1034-1040. doi: 10.1111/bju.14427. Epub 2018 Jul 26.

    PMID: 29873874DERIVED

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Guohua Zeng, PH.D and M.D

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of the Hospital

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

April 1, 2020

Record last verified: 2020-03

Locations

CN(1)