Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy in Renal Calculi

Renal Calculi Clinical Trial

Official title:

Tip-flexible Semi-rigid Ureterorenoscope Versus Flexible Ureteroscopy for the Treatment of Renal Calculi < 3 cm - Efficacity Prospective Randomized Multicentre Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02426931
• Other study ID #: 01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 12, 2015
• Last updated: April 22, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: April 2015
• Source: Changhai Hospital
• Contact: Ling Li, MD
• Phone: 086-18019766513
• Email: ejdll[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.

Description:

Retrograde intrarenal surgery using flexible ureteroscope has become the first-line treatment for renal calculi < 3.0 cm and is recommended by the European Association of Urology due to its minimally-invasive nature and satisfactory result.

However, some limitations still remain. Poor maneuverability, extra costs for the ureteral access sheath, and high device vulnerability still preclude flexible ureteroscopy from wider distribution.

Recently, the investigators present a novel ureterorenoscope, which is composed of a retractable rigid sheath and a semi-rigid ureteroscope with a flexible part on the tip. When the flexible tip of the inner shaft maintains within the sheath, working in the "rigid mode", the tip-flexible semi-rigid ureterorenoscope is capable of passing either the orifice or the physiological tortuosity of the ureter with ease. When the inner shaft is extended beyond the sheath, the endoscope is switched to the "flexible mode", capable of performing an intrarenal approach.

This endoscope integrates the classic semi-rigid and flexible ureteroscope both structurally and functionally, and has been approved for clinical application by the China Food and Drug Administration. In this study, transverse comparison is designed to evaluate the safety and efficacy of the tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject has provided informed consent and indicated a willingness to comply with study treatments

• Subject has a diagnosis of renal stones according to computer tomography (CT) and intravenous pyelogram (IVP) results

• Subject is a surgical candidate for the ureteroscopic approach

• Subject is 18-80 yrs of age

• Subject has a single stone < 3 cm in size (IVP), or multiple stones < 3 cm in cumulative size (IVP)

• Subject has a serum creatinine level within the normal range for the study center

Exclusion Criteria:

• Subject needs bilateral procedures within one-stage ureteroscopy

• Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)

• Subject has been diagnosed with a urethral stricture or bladder neck contracture

• Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks

• Subject has severe hematuria that might blur the vision of the endoscopy

• Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding

• Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)

• Subject has other diseases and could not tolerate the endoscopic surgery

• Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery

• Subject has ipsilateral pre-stenting or previous ureteroscopy within six months

• Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Calculi

Intervention

Device:
• the tip-flexible ureterorenoscope
Ureteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique.
• the classic flexible ureteroscope
Ureteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Ling Li, MD	Changhai Hospital, Ningbo No. 1 Hospital, The First Affiliated Hospital of Guangzhou Medical University, Tsinghua Changgung Hospital, West China Hospital, Xiangya Hospital of Central South University, Yantai Yuhuangding Hospital

References & Publications (16)

Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30. Review. — View Citation

Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12. — View Citation

Bedke J, Leichtle U, Lorenz A, Nagele U, Stenzl A, Kruck S. 1.2 French stone retrieval baskets further enhance irrigation flow in flexible ureterorenoscopy. Urolithiasis. 2013 Apr;41(2):153-7. doi: 10.1007/s00240-012-0540-9. Epub 2013 Jan 5. — View Citation

de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17. — View Citation

Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3. Review. — View Citation

Geavlete P, Multescu R, Geavlete B. Retrograde flexible ureteroscopic approach of upper urinary tract pathology: What is the status in 2014? Int J Urol. 2014 Nov;21(11):1076-84. doi: 10.1111/iju.12582. Epub 2014 Aug 1. Review. — View Citation

Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72. Erratum in: Urol J. 2015 Jul-Aug;12(4):2294. Sofikerim, Mustafa [Deleted]. — View Citation

Özsoy M, Acar Ö, Sarica K, Saratlija-Novakovic Z, Fajkovic H, Librenjak D, Esen T, Scheffbuch N, Seitz C. Impact of gender on success and complication rates after ureteroscopy. World J Urol. 2015 Sep;33(9):1297-302. doi: 10.1007/s00345-014-1435-x. Epub 2014 Nov 12. — View Citation

Perez Castro E, Osther PJ, Jinga V, Razvi H, Stravodimos KG, Parikh K, Kural AR, de la Rosette JJ; CROES Ureteroscopy Global Study Group. Differences in ureteroscopic stone treatment and outcomes for distal, mid-, proximal, or multiple ureteral locations: the Clinical Research Office of the Endourological Society ureteroscopy global study. Eur Urol. 2014 Jul;66(1):102-9. doi: 10.1016/j.eururo.2014.01.011. Epub 2014 Jan 23. — View Citation

Rebuck DA, Macejko A, Bhalani V, Ramos P, Nadler RB. The natural history of renal stone fragments following ureteroscopy. Urology. 2011 Mar;77(3):564-8. doi: 10.1016/j.urology.2010.06.056. Epub 2010 Dec 15. — View Citation

Somani BK, Al-Qahtani SM, de Medina SD, Traxer O. Outcomes of flexible ureterorenoscopy and laser fragmentation for renal stones: comparison between digital and conventional ureteroscope. Urology. 2013 Nov;82(5):1017-9. doi: 10.1016/j.urology.2013.07.017. Epub 2013 Aug 31. — View Citation

Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8. — View Citation

Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5. — View Citation

Wendt-Nordahl G, Trojan L, Alken P, Michel MS, Knoll T. Ureteroscopy for stone treatment using new 270 degrees semiflexible endoscope: in vitro, ex vivo, and clinical application. J Endourol. 2007 Dec;21(12):1439-44. doi: 10.1089/end.2006.0291. — View Citation

Yinghao S, Yang B, Gao X. The management of renal caliceal calculi with a newly designed ureteroscope: a rigid ureteroscope with a deflectable tip. J Endourol. 2010 Jan;24(1):23-6. doi: 10.1089/end.2009.0030. — View Citation

Yoon PD, Chalasani V, Woo HH. Use of Clavien-Dindo classification in reporting and grading complications after urological surgical procedures: analysis of 2010 to 2012. J Urol. 2013 Oct;190(4):1271-4. doi: 10.1016/j.juro.2013.04.025. Epub 2013 Apr 11. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone clearance	Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%	12 weeks post-operatively	No
Secondary	Stone clearance	Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group *100%	One day post-operatively	No
Secondary	Complication rates	Number of participants undergo tf-URS or f-URS surgeries suffer complications associated with the surgery (i.e. painess(NRS=4), hematuria, T=38?, serum WBC=12×?10?^9/L ,serum WBC<4×?10?^9/L, perforation, etc.)/Total number of participants in each group *100%	Within 12 weeks after surgery	Yes
Secondary	Endoscope deflection loss rates	Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with deflection loss>10%/Total number of ureterorenoscope or ureterosocpe used *100%	intraoperative	No
Secondary	Endoscope Leakage rates	Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with leakage of the working channel or the outer shaft/times of the ureterorenoscope or ureterosocpe used *100%	intraoperative	No
Secondary	Endoscope black dots rates	Number of the broken novel ureterorenoscope or the broken classic flexible ureterosocpe with black dots on endoscopic images/times of ureterorenoscope or ureterosocpe used *100%	intraoperative	No