NCT02635048

Brief Summary

Percutaneous nephrolithotomy (PCNL) has been considered as the first-line choice for the management of \>20mm kidney stones. The traditional nephrostomy tract of PNL was dilated to 24-30F, which is referred to as "Standard-PCNL". Standard PNL has an ideal stones free rate (SFR), however, at the cost of severe morbidity. To decrease the disadvantages related to standard PNL, "mini-perc" or "mini-PCNL", 20F or less, was first introduced to pediatric procedure in 1997, and subsequently implemented in adults with the expectation of similar SFR and low morbidity in the past twenty years. Although abundant efforts have been done, whether mini-perc outweigh standard-PNL for the treatment of \>20mm calculis in terms of efficiency and safety remains controversial. To solve this problem, we performed this multicenter, parallel, open-label randomized controlled trial (RCT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,980

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 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

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

3.6 years

First QC Date

December 16, 2015

Last Update Submit

March 3, 2020

Conditions

Kidney Calculi

Keywords

Percutaneous nephrolithotomyKidney stonesEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • Stone free rate (SFR)

    2mm Non-contrast CT is obtained for all patients at 1 month after removing the pigtail stent to evaluate the final 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 ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles.

    1 month after removing the pigtail stent

Secondary Outcomes (1)

  • Perioperative complications

    intraoperatively or ≤ 1 month postoperatively

Study Arms (2)

Group 1

OTHER

Patients in Group 1 undergo mini percutaneous nephrolithotomy

Procedure: Mini Percutaneous Nephrolithotomy

Group 2

OTHER

Patients in Group 2 undergo percutaneous nephrolithotomy

Procedure: Percutaneous Nephrolithotomy

Interventions

Mini Percutaneous NephrolithotomyPROCEDURE

patients undergo PNCL with 18Fr nephrostomy tract

Group 1
Percutaneous NephrolithotomyPROCEDURE

patients undergo PNCL with 24Fr nephrostomy tract

Group 2

Eligibility Criteria

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

You may qualify if:

  • Patients consent for percutaneous renal stone removal
  • Age 18 to 70 years
  • Normal renal function
  • ASA score Ⅰ and Ⅱ
  • Renal stones 20-40mm

You may not qualify if:

  • Patients with solitary kidney.
  • Uncorrected coagulopathy and active urinary tract infection (UTI)
  • Morbid obese patients
  • Patients who underwent transplant or urinary diversion.
  • Congenital abnormalities.

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

MeSH Terms

Conditions

Kidney Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LaparoscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Guohua Zeng, PH.D & MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 20, 2019

Last Updated

March 5, 2020

Record last verified: 2020-03

Locations

CN(1)