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

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02266381
• Collaborator: (none)
• Enrollment: 450
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 37.5

Study Details

Study Description

Brief Summary

Purpose:

The aim of this present study is to compare the result of fluoroscopy, ultrasonography (US) and US combined with fluoroscopy in the guidance of minimally invasive percutaneous nephrolithotomy (MPCNL).

Methods:

The investigators will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL). In addition to approaches in guidance of MPCNL, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis	Procedure: US-guided renal access; Procedure: Fluoroscopy-guided renal access; Procedure: US combined with fluoroscopy-guided renal access	N/A

Detailed Description

Purpose:

Recently, PCNL or MPCNL is widely used as the most popular choice to treat patients with all types of renal stones. Successful puncture to the desired renal calyx is the key step for the operation. Nowadays puncture for renal access can be achieve using not only US guidance but fluoroscopy guidance as well. However, it is clear that there is a lack of randomized controlled data comparing fluoroscopy, US and US combined with fluoroscopy in the guidance of MPCNL. Consequently, we performed this randomized controlled trial to obtain higher grade evidence.The aim of this present study is to compare the result of fluoroscopy, US and US combined with fluoroscopy in the guidance of MPCNL.

Methods:

We will enroll 450 patients who are candidates for MPCNL in our study. By simple random sampling technique, patients will be assigned to three 150-patient groups (group 1, US-guided MPCNL, group 2, fluoroscopy-guided MPCNL and group 3, US combined with fluoroscopy-guided MPCNL).

All the patients will be diagnosed definitely before operations with kidney, ureter, and bladder (KUB), intravenous pyelography (IVP), US and/or CT.

All procedures are performed by urologists in our center, with assistance from an endourology fellow.

Surgical technique:

Under general or epidural anaesthesia, each patient is initially placed in the lithotomy position, and a 5 Fr ureteric catheter is advanced to the kidney and fixed with a 16 Fr Foley catheter. Then the patient is turned to the prone position.

Group 1: US-guided MPCNL The puncture is made with an 18-gauge needle using an ultrasound probe. After the desirable calix is reached, a flexible-tip guidewire is introduced. We attempt to manipulate the guidewire down to the ureter. If this is not successful, the second choice is to allow the guidewire to coil in a more distant calix. The length of the needle from skin to the collecting system is measured to ensure that the length of dilator is appropriate. The access tract is dilated from 8 Fr to a maximum 18/20 Fr using fascial dilator. We defined access to the collecting system as gaining entry to the targeted urinary system and desired calix.

Lithotripsy is performed using either pneumatic lithotriptor or holmium laser. When multiple nephrostomy tracts are necessary to remove the stones, same technique is employed for each of the tracts.

Complete stone clearance is confirmed using US at completion of the procedure. We routinely put a double J ureteral catheter into the ureter which is to be removed about 3-4 weeks later after the operation in the out-patients clinic. At the end of the procedure nephrostomy tubes are placed in both groups. The tubes are removed when the drainage from nephrostomy tubes being grossly clear.

Group 2 fluoroscopy-guided MPCNL Patients in group 2 have the standard fluoroscopy-guided renal access before MPCNL. Air or contrast medium is injected through the ureteral catheter, the target calix is identified. For tract dilatation fascial dilators are used under fluoroscopic guidance.

Complete stone clearance is confirmed fluoroscopically at completion of the procedure.

The rest of the procedure is the same as described for patients in group 1.

Group 3 US combined with fluoroscopy-guided MPCNL:

Under the guidance of ultrasound, the coaxial needle is placed in the desired calyx. A floppy-tipped guidewire is then passed through the needle into the collecting system. The working channel is then dilated under X-ray.

US and X-ray check for residual stone fragments are performed at the end of the procedure.

The rest of the procedure is the same as described for patients in group 1.

Data collection:

Data for the three groups -demographic characteristics, access success, access time, duration of radiation exposure, site of target calix, site of access, Hb decrease, duration of postoperative hospital stay, complications (modified Clavien system), stone clearance (SFR after single procedure and final SFR) and the need for auxiliary treatment - are compared.

The primary end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Study Design

• Study Type: Interventional
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective and Randomized Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: US-guided group Patients in US-guided group undergo MPCNL using only US-guided renal access.	Procedure: US-guided renal access; Patients undergo MPCNL using only US-guided renal access.
Other: Fluoroscopy-guided group Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Procedure: Fluoroscopy-guided renal access; Patients undergo MPCNL using only fluoroscopy-guided renal access.
Other: Combined-guided group Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.	Procedure: US combined with fluoroscopy-guided renal access; Patients undergo MPCNL using US combined with fluoroscopy-guided renal access

Outcome Measures

Primary Outcome Measures

1. Stone Free Rate [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.

Secondary Outcome Measures

1. Perioperative Complications [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.

2. Operation Time [intraoperatively]

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

3. Change in Hemoglobin Concentration [within 24 hours after MPCNL]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Normal renal function.

• American society of Anesthesiology (ASA) score 1 and 2.

• Absence of congenital abnormalities.

• Kidney stones of diameter > 2.0cm (including multiple and staghorn stones)

Exclusion Criteria:

• Patients with congenital anomalies, e.g. ectopic kidney, polycystic, horseshoe, or malrotated kidney.

• Patients who underwent transplant or urinary diversion.

• Patients with solitary kidney.

• Patients will be excluded from the study if they undergoing MPCNL have purulent fluid in the initial puncture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510230

Sponsors and Collaborators

• The First Affiliated Hospital of Guangzhou Medical University

Investigators

• Study Chair: Guohua Zeng, PH.D and M.D, The First Affiliated Hospital of Guangzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Agarwal M, Agrawal MS, Jaiswal A, Kumar D, Yadav H, Lavania P. Safety and efficacy of ultrasonography as an adjunct to fluoroscopy for renal access in percutaneous nephrolithotomy (PCNL). BJU Int. 2011 Oct;108(8):1346-9. doi: 10.1111/j.1464-410X.2010.10002.x. Epub 2011 Jan 20.
• Basiri A, Ziaee AM, Kianian HR, Mehrabi S, Karami H, Moghaddam SM. Ultrasonographic versus fluoroscopic access for percutaneous nephrolithotomy: a randomized clinical trial. J Endourol. 2008 Feb;22(2):281-4. doi: 10.1089/end.2007.0141.
• Desai M, Jain P, Ganpule A, Sabnis R, Patel S, Shrivastav P. Developments in technique and technology: the effect on the results of percutaneous nephrolithotomy for staghorn calculi. BJU Int. 2009 Aug;104(4):542-8; discussion 548. doi: 10.1111/j.1464-410X.2009.08472.x. Epub 2009 Mar 6.
• Li X, Long Q, Chen X, He D, He H. Real-time ultrasound-guided PCNL using a novel SonixGPS needle tracking system. Urolithiasis. 2014 Aug;42(4):341-6. doi: 10.1007/s00240-014-0671-2. Epub 2014 Jun 26. Erratum in: Urolithiasis. 2014 Oct;42(5):473. Dalin, He [corrected to He, Dalin].
• Lu MH, Pu XY, Gao X, Zhou XF, Qiu JG, Si-Tu J. A comparative study of clinical value of single B-mode ultrasound guidance and B-mode combined with color doppler ultrasound guidance in mini-invasive percutaneous nephrolithotomy to decrease hemorrhagic complications. Urology. 2010 Oct;76(4):815-20. doi: 10.1016/j.urology.2009.08.091. Epub 2010 Jun 25.
• Mozer P, Conort P, Leroy A, Baumann M, Payan Y, Troccaz J, Chartier-Kastler E, Richard F. Aid to percutaneous renal access by virtual projection of the ultrasound puncture tract onto fluoroscopic images. J Endourol. 2007 May;21(5):460-5.
• Opondo D, Gravas S, Joyce A, Pearle M, Matsuda T, Sun YH, Assimos D, Denstedt J, de la Rosette J. Standardization of patient outcomes reporting in percutaneous nephrolithotomy. J Endourol. 2014 Jul;28(7):767-74. doi: 10.1089/end.2014.0057. Epub 2014 Apr 16. Review.
• Yan S, Xiang F, Yongsheng S. Percutaneous nephrolithotomy guided solely by ultrasonography: a 5-year study of >700 cases. BJU Int. 2013 Nov;112(7):965-71. doi: 10.1111/bju.12248. Epub 2013 Jul 26.

• Responsible Party: Guohua Zeng, Vice President of the Hospital, The First Affiliated Hospital of Guangzhou Medical University
• ClinicalTrials.gov Identifier: NCT02266381
• Other Study ID Numbers: MRER(29)2014
• First Posted: Oct 17, 2014
• Last Update Posted: Nov 9, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Guohua Zeng, Vice President of the Hospital, The First Affiliated Hospital of Guangzhou Medical University: PCNL; MPCNL; guidance; puncture
• Additional relevant MeSH terms: Urolithiasis

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	549 consecutive patients were assessed for eligibility, 99 were excluded for not meeting the inclusion criteria.

Arm/Group Title	US-guided Group	Fluoroscopy-guided Group	Combined-guided Group
Arm/Group Description	Patients in US-guided group undergo MPCNL using only US-guided renal access.	Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Period Title: Overall Study
STARTED	150	150	150
COMPLETED	147	145	146
NOT COMPLETED	3	5	4

Baseline Characteristics

Arm/Group Title	US-guided Group	Fluoroscopy-guided Group	Combined-guided Group	Total
Arm/Group Description	Patients in US-guided group undergo MPCNL using only US-guided renal access.	Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.	Total of all reporting groups
Overall Participants	147	145	146	438
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.9 (10.9)	49.6 (11.3)	48.8 (11.3)	49.4 (11.1)
Sex: Female, Male (Count of Participants)
Female	61 41.5%	68 46.9%	58 39.7%	187 42.7%
Male	86 58.5%	77 53.1%	88 60.3%	251 57.3%
Region of Enrollment (participants) [Number]
China	147 100%	145 100%	146 100%	438 100%

Outcome Measures

1. Primary Outcome

Title	Stone Free Rate
Description	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.
Time Frame	one day after MPCNL

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	US-guided Group	Fluoroscopy-guided Group	Combined-guided Group
Arm/Group Description	Patients in US-guided group undergo MPCNL using only US-guided renal access.	Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Measure Participants	147	145	146
Number [Participants]	81 55.1%	91 62.8%	98 67.1%

2. Secondary Outcome

Title	Perioperative Complications
Description	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.
Time Frame	intraoperatively or ≤ 30 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	US-guided Group	Fluoroscopy-guided Group	Combined Group
Arm/Group Description	Patients in US-guided undergo MPCNL using only US-guided renal access.	Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Patients in Combined group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Measure Participants	147	145	146
Number [Participants]	17 11.6%	31 21.4%	20 13.7%

3. Secondary Outcome

Title	Operation Time
Description	Operation time is defined as the time from puncture to the placement of the nephrostomy tube.
Time Frame	intraoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	US-guided Group	Fluoroscopy-guided Group	Combined-guided Group
Arm/Group Description	Patients in US-guided group undergo MPCNL using only US-guided renal access.	Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Measure Participants	147	145	146
Mean (Standard Deviation) [min]	60.6 (32.9)	63.6 (32.5)	66.3 (34.7)

4. Secondary Outcome

Title	Change in Hemoglobin Concentration
Description	Change in hemoglobin concentration is assessed by comparing the preoperative hemoglobin level with 24-hour postoperative hemoglobin level.
Time Frame	within 24 hours after MPCNL

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	US-guided Group	Fluoroscopy-guided Group	Combined-guided Group
Arm/Group Description	Patients in US-guided group undergo MPCNL using only US-guided renal access.	Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.	Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
Measure Participants	147	145	146
Mean (Standard Deviation) [g/L]	12.9 (16.0)	14.5 (10.0)	13.1 (10.8)

Adverse Events

Arm/Group Title	US-guided Group		Fluoroscopy-guided Group		Combined-guided Group
Arm/Group Description	Patients in US-guided group undergo MPCNL using only US-guided renal access.		Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.		Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
All Cause Mortality
	US-guided Group		Fluoroscopy-guided Group		Combined-guided Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	US-guided Group		Fluoroscopy-guided Group		Combined-guided Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/145 (0%)		0/146 (0%)
Other (Not Including Serious) Adverse Events
	US-guided Group		Fluoroscopy-guided Group		Combined-guided Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/147 (11.6%)		31/145 (21.4%)		20/146 (13.7%)
Surgical and medical procedures
Perioperative complications	17/147 (11.6%)		31/145 (21.4%)		20/146 (13.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.