Trial Outcomes & Findings for A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy (NCT NCT02266381)

Results Overview

Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter \>4 mm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

450 participants

Primary outcome timeframe

one day after MPCNL

Results posted on

2016-11-09

Participant Flow

A prospective and randomized study was performed with patient enrollment from July 2014 to May 2015 in the First Affilated Hospital of Guangzhou Medical University. 450 patients were then randomized into three groups. 12 patients had purulent fluid in the kidney at initial punctures. These 12 patients were excluded from the analysis.

549 consecutive patients were assessed for eligibility, 99 were excluded for not meeting the inclusion criteria.

Participant milestones

Participant milestones
Measure	US-guided Group Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Overall Study STARTED	150	150	150
Overall Study COMPLETED	147	145	146
Overall Study NOT COMPLETED	3	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	US-guided Group Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Overall Study Physician Decision	3	5	4

Baseline Characteristics

A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	US-guided Group n=147 Participants Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group n=145 Participants Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group n=146 Participants Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.	Total n=438 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 10.9 • n=5 Participants	49.6 years STANDARD_DEVIATION 11.3 • n=7 Participants	48.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	49.4 years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	68 Participants n=7 Participants	58 Participants n=5 Participants	187 Participants n=4 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	77 Participants n=7 Participants	88 Participants n=5 Participants	251 Participants n=4 Participants
Region of Enrollment China	147 participants n=5 Participants	145 participants n=7 Participants	146 participants n=5 Participants	438 participants n=4 Participants

PRIMARY outcome

Timeframe: one day after MPCNL

Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter \>4 mm.

Outcome measures

Outcome measures
Measure	US-guided Group n=147 Participants Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group n=145 Participants Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group n=146 Participants Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Stone Free Rate	81 Participants	91 Participants	98 Participants

SECONDARY outcome

Timeframe: intraoperatively or ≤ 30 days postoperatively

Complication is defined as any adverse event occurred intraoperatively or ≤ 30 days postoperatively. Complications included fever, systemic Inflammatory Response Syndrome, septic shock, extravasations, bleeding necessitating transfusion, and sever bleeding necessitating selective renal artery embolization.

Outcome measures

Outcome measures
Measure	US-guided Group n=147 Participants Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group n=145 Participants Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group n=146 Participants Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Perioperative Complications	17 Participants	31 Participants	20 Participants

SECONDARY outcome

Timeframe: intraoperatively

Operation time is defined as the time from puncture to the placement of the nephrostomy tube.

Outcome measures

Outcome measures
Measure	US-guided Group n=147 Participants Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group n=145 Participants Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group n=146 Participants Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Operation Time	60.6 min Standard Deviation 32.9	63.6 min Standard Deviation 32.5	66.3 min Standard Deviation 34.7

SECONDARY outcome

Timeframe: within 24 hours after MPCNL

Change in hemoglobin concentration is assessed by comparing the preoperative hemoglobin level with 24-hour postoperative hemoglobin level.

Outcome measures

Outcome measures
Measure	US-guided Group n=147 Participants Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group n=145 Participants Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group n=146 Participants Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Change in Hemoglobin Concentration	12.9 g/L Standard Deviation 16.0	14.5 g/L Standard Deviation 10.0	13.1 g/L Standard Deviation 10.8

Adverse Events

US-guided Group

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Fluoroscopy-guided Group

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Combined-guided Group

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	US-guided Group n=147 participants at risk Patients in US-guided group undergo MPCNL using only US-guided renal access.	Fluoroscopy-guided Group n=145 participants at risk Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Combined-guided Group n=146 participants at risk Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Surgical and medical procedures Perioperative complications	11.6% 17/147	21.4% 31/145	13.7% 20/146

Additional Information

Dr. Guohua Zeng

The First Affiliated Hospital of Guangzhou Medical University

Phone: 0086-20-34294163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place