NCT03206515

Brief Summary

Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of \>20mm kidney stones. Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications. At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on. But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness. Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

October 27, 2016

Last Update Submit

June 29, 2017

Conditions

Renal Calculi

Keywords

Renal Pelvic Pressure

Outcome Measures

Primary Outcomes (1)

  • The renal pelvic pressure

    To measure the renal pelvic pressure during mini-PCNL procedure

    During the procedure

Secondary Outcomes (1)

  • Perioperative complications

    Intraoperatively or ≤ 1 month postoperatively

Study Arms (2)

Group 1

OTHER

Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group

Device: 18F Peel-Way Sheath

Group 2

OTHER

Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group

Device: 18F access sheath with a suction-evacuation function

Interventions

18F Peel-Way SheathDEVICE

Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath

Group 1
18F access sheath with a suction-evacuation functionDEVICE

Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function

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 20-50mm

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
  • Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510230, China

RECRUITING

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

Central Study Contacts

Guohua Zeng, PH.D and M.D

CONTACT

+86 13802916676gzgyzgh@vip.tom.com

Guangming Chen

CONTACT

+86132468882131172676107@qq.com

Study Design

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

Study Record Dates

First Submitted

October 27, 2016

First Posted

July 2, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

CN(1)