Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone

Stone Ureter Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Semi-rigid Ureteroscopy and Flexible Ureteroscopy For the Treatment of Proximal Ureteric Stone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04851171
• Other study ID #: MRC-01-19-036
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2020
• Est. completion date: January 2023

Study information

• Verified date: April 2021
• Source: Hamad Medical Corporation
• Contact: Ibrahim Alnadhari, MD, FRCS Uro
• Phone: +974-33403324/ +974-40115093
• Email: ibrahimah1978[@]yahoo.com, IAlnadhari[@]hamad.qa,
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is randomized in nature, comparing the stone free rate and complications rate between semi-rigid ureteroscopy (SR-URS) and Flexible Ureteroscopy (F-URS) for the treatment of Proximal Ureteric stone (PUS), whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

Description:

There are various treatment options that can be used for the treatment of PUS, which include extracorporeal shockwave lithotripsy (SWL), ureteroscopy (URS), percutaneous nephrolithotomy (PCNL), antegrade uretero-lithotripsy, laparoscopy, and rarely, open surgical procedures. However, the standard, and the most frequently used modalities are SWL and ureteroscopy. When comparing the effectiveness in the treatment of Proximal Ureteric stone (PUS) between SWL and URS, SWL has lower rates of complication and morbidity, but URS has a higher likelihood of successfully treating the patient within a single procedure. Additionally, with the advancements in technology and miniaturization of the ureteroscopes, along with the presence of auxiliary instruments such as holmium laser and retrieval baskets, ureteroscopy is more widely used.

In the proximal ureter, SR-URS tends to encounter difficulties in accessing the stone, but F-URS aids in overcoming those difficulties. As a result, the use of F-URS for PUS has indicated a strong success rate with lower likelihood of complications. When comparing the drawbacks of the two types of modalities, F-URS tends to be more expensive, and requires auxiliary instruments. And SR-URS tends to have lower success rate along with an increased rate in complications.

The precedence of FURS over SR-URS in the treatment of PUS is yet to be extensively studied. Presently there are only five studies that have compared the two modalities of treatment. But, due to the lack standardization of variables, procedure, follow-up imaging and reporting of outcomes in the past studies, it is imperative to conduct study that is prospective and randomized in nature.

The present study is randomized in nature, comparing the stone free rate and complications rate between SR-URS and F-URS for the treatment of PUS, whereby the preoperative assessments, procedure and reporting of outcomes will all be standardized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Single proximal ureteric stone indicated for active treatment with ureteroscopy (stented or non-stented)

Exclusion Criteria:

• Solitary Kidney

• Bilateral ureteric stones

• Ipsilateral multiple simultaneous ureteric stones

• Ipsilateral kidney stone

• Active UTI

• Coagulopathy diseases

• Ipsilateral ureteral anomalies, ureteral disorder (tumor or stricture) or previous ureteral open surgery.

• Pregnant patients.

• Unable to give informed consent.

• Patient is not agreeing to go through the randomization.

Related Conditions & MeSH terms

• Calculi
• Stone Ureter
• Ureteral Calculi
• Ureteric Stone
• Ureterolithiasis

Intervention

Procedure:
• Flexible Ureteroscopy
Flexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
• Semi-rigid Ureteroscopy
Semi-rigid ureteroscopy is the use of the semi-rigid ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.

Locations

Country	Name	City	State
Qatar	Al Wakra Hospital	Al-Wakrah	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (7)

Alkan E, Saribacak A, Ozkanli AO, Basar MM, Acar O, Balbay MD. Flexible Ureteroscopy Can Be More Efficacious in the Treatment of Proximal Ureteral Stones in Select Patients. Adv Urol. 2015;2015:416031. doi: 10.1155/2015/416031. Epub 2015 Nov 4. — View Citation

Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27. — View Citation

Galal EM, Anwar AZ, El-Bab TK, Abdelhamid AM. Retrospective comparative study of rigid and flexible ureteroscopy for treatment of proximal ureteral stones. Int Braz J Urol. 2016 Sep-Oct;42(5):967-972. doi: 10.1590/S1677-5538.IBJU.2015.0644. — View Citation

Hyams ES, Monga M, Pearle MS, Antonelli JA, Semins MJ, Assimos DG, Lingeman JE, Pais VM Jr, Preminger GM, Lipkin ME, Eisner BH, Shah O, Sur RL, Mufarrij PW, Matlaga BR. A prospective, multi-institutional study of flexible ureteroscopy for proximal ureteral stones smaller than 2 cm. J Urol. 2015 Jan;193(1):165-9. doi: 10.1016/j.juro.2014.07.002. Epub 2014 Jul 9. — 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

Lee JH, Woo SH, Kim ET, Kim DK, Park J. Comparison of Patient Satisfaction with Treatment Outcomes between Ureteroscopy and Shock Wave Lithotripsy for Proximal Ureteral Stones. Korean J Urol. 2010 Nov;51(11):788-93. doi: 10.4111/kju.2010.51.11.788. Epub 2010 Nov 17. — View Citation

Wolf JS Jr. Treatment selection and outcomes: ureteral calculi. Urol Clin North Am. 2007 Aug;34(3):421-30. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rate	Sone free status will be assessed by doing CT KUB scan 4 weeks postoperative and it is defined as patients with no residual stones or clinically insignificant residual fragments (< 2 mm).	Four weeks
Secondary	Complication rate	To evaluate the complication rate post procedure including infection rate, genitourinary injury, hematuria, emergency visits rate and we will use of modified Calvin Dindo classification to grade the surgical complications.	Three Months
Secondary	To compare stone free rate and complications between patients with ureteric stent and patients without ureteric stent	Patients will be stratified into two groups: group 1 with ureteric stents and group 2 without ureteric stents. Then comparison between the two groups in regards the stone free rate and the complications rate as per the previous definitions.	Three Months

External Links

•   Türk C, Neisius A, Petrík A, Seitz C, Skolarikos A, Thomas K. EAU Guidelines on Urolithiasis