Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS

NCT03307096 | Withdrawn DMC

• 1 other identifier: NBDYYY2017003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone

Conditions

Surgery--Complications; Renal Calculus; Nephrolithiasis; Urolithiasis

Keywords

FURS; microperc; renal calculus; Randomized Controlled Trial; Retrograde Intrarenal Surgery

Outcome Measures

Primary Outcomes (1)

• SFR

  Stone free Rate

  3 month

Secondary Outcomes (5)

• Complications

  3 month

• Duration of postoperative hospital stay

  7 days

• Postoperative pain

  3 month

• The rate of hemoglobin decrease

  7 days

• Operation time

  12 hours

Study Arms (2)

Microperc surgery

EXPERIMENTAL

Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left.

Procedure: Microperc surgery

FURS

ACTIVE COMPARATOR

Patient is placed in the lithotomy position, pull out the pre-inserted double J, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 4 weeks.

Procedure: FURS

Interventions

Microperc surgery PROCEDURE

Parents are treated by Microperc Percutaneous Nephrolithotomy

Microperc surgery

FURS PROCEDURE

Parents are treated by FURS

FURS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• mm lower pole renal stone measured by KUB or CT;
• Age between 18-60 years, no gender limitation;
• Participators can understand the research and sign the consent form without mental illness nor language disorder;
• Low pole renal stone left after lithotripsy;
• Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30 degree;
• Asymptomatic patients with positive urine white blood cells and negative preoperative urine culture should be treated with antibiotics for 3days before operation;
• Patients with symptoms of urinary infections, positive urine withe blood cells and positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 7days before operation.

You may not qualify if:

• Transplant kidney stone;
• Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney, horseshoe kidney, etc.;
• Combine other part of urinary stones need to be handle at the same procedure, for example ureteral stone, renal pelvic stone, middle or upper pole renal stone;
• Hematological Disease or Coagulation disorders;
• Withdraw anticoagulant medicine less than two weeks;
• Sevier renal dysfunction(endogenous creatinine clearance rate≤50ml/min)
• Middle or severe hydronephrosis(dilatation of the renal pelvis ≥20mm by ultrasound);
• Women in menstrual period or pregnancy;
• Patients have severe disease, such as heart disease, lung dysfunction, and multiple organ failure that cannot tolerate anesthesia or operation.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead
• Beijing Friendship Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Affiliated Hospital of Hebei University: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator
• West China Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• People's Hospital of Anshun City of Guizhou Province: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• General Hospital of Shenyang Military Region: collaborator

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

Related Publications (13)

• Sener NC, Imamoglu MA, Bas O, Ozturk U, Goktug HN, Tuygun C, Bakirtas H. Prospective randomized trial comparing shock wave lithotripsy and flexible ureterorenoscopy for lower pole stones smaller than 1 cm. Urolithiasis. 2014 Apr;42(2):127-31. doi: 10.1007/s00240-013-0618-z. Epub 2013 Nov 13.

  PMID: 24220692 BACKGROUND

• Ozgur Tan M, Irkilata L, Sen I, Onaran M, Kupeli B, Karaoglan U, Bozkirli I. The impact of radiological anatomy in clearance of lower caliceal stones after shock wave lithotripsy. Urol Res. 2007 Jun;35(3):143-7. doi: 10.1007/s00240-007-0093-5. Epub 2007 Apr 20.

  PMID: 17447057 BACKGROUND

• Juan YS, Chuang SM, Wu WJ, Shen JT, Wang CJ, Huang CH. Impact of lower pole anatomy on stone clearance after shock wave lithotripsy. Kaohsiung J Med Sci. 2005 Aug;21(8):358-64. doi: 10.1016/S1607-551X(09)70134-2.

  PMID: 16158878 BACKGROUND

• Turk C. [Urolithiasis guidelines: retrospective view and perspectives]. Urologe A. 2016 Oct;55(10):1317-1320. doi: 10.1007/s00120-016-0230-2. German.

  PMID: 27604704 BACKGROUND

• Molina WR, Kim FJ, Spendlove J, Pompeo AS, Sillau S, Sehrt DE. The S.T.O.N.E. Score: a new assessment tool to predict stone free rates in ureteroscopy from pre-operative radiological features. Int Braz J Urol. 2014 Jan-Feb;40(1):23-9. doi: 10.1590/S1677-5538.IBJU.2014.01.04.

  PMID: 24642147 BACKGROUND

• Elbahnasy AM, Clayman RV, Shalhav AL, Hoenig DM, Chandhoke P, Lingeman JE, Denstedt JD, Kahn R, Assimos DG, Nakada SY. Lower-pole caliceal stone clearance after shockwave lithotripsy, percutaneous nephrolithotomy, and flexible ureteroscopy: impact of radiographic spatial anatomy. J Endourol. 1998 Apr;12(2):113-9. doi: 10.1089/end.1998.12.113.

  PMID: 9607435 BACKGROUND

• Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.

  PMID: 22840867 RESULT

• Kilicarslan H, Kaynak Y, Kordan Y, Kaygisiz O, Coskun B, Gunseren KO, Kanat FM. Unfavorable anatomical factors influencing the success of retrograde intrarenal surgery for lower pole renal calculi. Urol J. 2015 Apr 29;12(2):2065-8.

  PMID: 25923149 RESULT

• Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.

  PMID: 21855968 RESULT

• Inoue T, Murota T, Okada S, Hamamoto S, Muguruma K, Kinoshita H, Matsuda T; SMART Study Group. Influence of Pelvicaliceal Anatomy on Stone Clearance After Flexible Ureteroscopy and Holmium Laser Lithotripsy for Large Renal Stones. J Endourol. 2015 Sep;29(9):998-1005. doi: 10.1089/end.2015.0071. Epub 2015 May 15.

  PMID: 25879676 RESULT

• Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.

  PMID: 23826843 RESULT

• Karatag T, Tepeler A, Silay MS, Bodakci MN, Buldu I, Daggulli M, Hatipoglu NK, Istanbulluoglu MO, Armagan A. A Comparison of 2 Percutaneous Nephrolithotomy Techniques for the Treatment of Pediatric Kidney Stones of Sizes 10-20 mm: Microperc vs Miniperc. Urology. 2015 May;85(5):1015-1018. doi: 10.1016/j.urology.2015.02.010.

  PMID: 25917724 RESULT

• Soderberg L, Ergun O, Ding M, Parker R, Borofsky MS, Pais V, Dahm P. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults. Cochrane Database Syst Rev. 2023 Nov 13;11(11):CD013445. doi: 10.1002/14651858.CD013445.pub2.

  PMID: 37955353 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Urolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yue Cheng, Dr.

  Ningbo No. 1 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Model Details: A total of 200 patients, aging between 18 and 60 years are enrolled into the study, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.

Study Record Dates

• First Submitted: September 30, 2017
• First Posted: October 11, 2017
• Study Start: November 17, 2017
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)