NCT05714423

Brief Summary

Due to the anatomic characteristics of the lower calyx, lower pole stones are difficult to be eliminated through the ureter, even if the stones had been fragmented. Retrograde intrarenal surgery (RIRS) can be used to deal with lower pole stones of 1.0-2.0 cm, while percutaneous nephrolithotripsy (PCNL) is mainly used to deal with lower pole stones with larger diameter or when RIRS failed to resolve the stone. This study was conducted to compare mini PCNL and retrograde intrarenal surgery (RIRS) for the management of lower pole kidney stones in terms of efficacy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

January 26, 2023

Last Update Submit

January 26, 2023

Conditions

Kidney Stone

Keywords

lower pole stone, mini PCNL, retrograde intrarenal surgery

Outcome Measures

Primary Outcomes (1)

  • Stone Clearance

    Number of patients cleared from stones assessed by CT scan KUB

    4 weeks

Secondary Outcomes (1)

  • Hospital Stay

    1 week

Study Arms (2)

Mini-PCNL Group

ACTIVE COMPARATOR

In this group kidney stones will be treated with Mini-PCNL Surgery

Procedure: Mini-PCNL

RIRS Group

ACTIVE COMPARATOR

In this group kidney stones will be treated with Retrograde Intrarenal Surgery.

Procedure: RIRS

Interventions

Mini-PCNLPROCEDURE

Mini-PCNL will done as follows. A 6 Fr ureteral catheter will be introduced through cystoscopy and dye will be instilled to opacify the pelvicalyceal system. After elaborating the calyceal system through fluoroscopy, selective calyceal will be punctured and tract will be dilated using 16 F sheath. Miniature nephroscope 14 Fr will be then introduced and stones will be fragmented by holmium: YAG laser. Afterwards the collecting system will be examined through nephroscope and fluoroscopic confirmation will be done to ensure complete stone clearance. In all the cases, 6 Fr 24 cm DJ stent will be placed and if remained uneventful, the patient will be discharged on postoperative day 2 with oral antibiotics.

Mini-PCNL Group
RIRSPROCEDURE

RIRS will be performed as follows. In this procedure a double J stent will be placed to dilate the calyceal system 2 weeks prior the surgery. During the procedure, cystoscopy will be done, and 0.035-inch guide wire will be placed in the pelvi-calyceal system. Ureteric access sheath of 12 Fr will be placed and with the help of digital polyscope the stone will be fragmented using Holmium: YAG laser using 220 μm fiber. DJ stent 6F 24 cm will be placed in all the cases. In uneventful surgery patient will be discharged on postoperative day 1 with oral antibiotics

RIRS Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal stone at lower pole of size 10mm -20mm

You may not qualify if:

  • Patients with positive urine culture,
  • Patients with anatomical abnormalities determined by ultrasonography
  • Uncontrolled diabetes (HbA1c \>9%)
  • Patients undergone previous renal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 6, 2023

Study Start

October 1, 2020

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

February 6, 2023

Record last verified: 2023-01

Locations

PA(1)