A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture

Stricture Ureter Clinical Trial

Official title:

A Prospective Multicenter Study of Balloon Dilatation for the Treatment of Benign

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04021901
• Other study ID #: SHOT-20181112
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

Description:

Benign ureteral stricture refers to a urinary tract obstruction caused by a partial or full ureteral lumen that is less normal than normal. It can lead to urinary dilatation, water accumulation, and renal colic in the upper segment of the stenosis. If treat not in time, it will affect renal function and even causes irreversible kidney failure.In recent years, with the development of endoscopic techniques, it provides a cost-effective and less invasive treatment for the treatment of ureteral stricture. In recent years, with the development of endoscopic techniques, it has provided a cost-effective and less invasive treatment for the treatment of ureteral stricture, and has achieved satisfactory results. Therefore, more and more urologists choose to treat ureteral stricture under endoscopy. The techniques of urinary endoscopic treatment of benign ureteral stricture include ureteral balloon dilatation, ureteral holmium laser incision, and ureteral stent implantation. Among them, the ureteral balloon dilatation technique is characterized by the use of a balloon to uniformly force the ureteral wall, tearing the narrow scar tissue, expanding the inner diameter of the ureter, recanalizing the urinary tract, and alleviating hydronephrosis. It have been reported with less complications and simple procedure. However, there's still no consensus on its treatment indication，procedure standards and curative effect. This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

• Subject is 18-70 yrs of age

• Subject can be either male or female

• Subject diagnosed with ureteral stricture or atresia by enhanced CTU, intravenous pyelography or retrograde pyelography;

• Subject's ureteral stenosis length is = 2cm (single or multiple segments)

Exclusion Criteria:

• • Subject has any congenital ureteral anatomical deformity, abdominal organ compression, oppression caused by malignant tumor metastasis

• Subject has poor result after endoscopic balloon dilatation treatment

• Subject has a GFR <25% on the affected side of the kidney

• 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 is pregnant or in monthly period

• Subject has coexistent disease like systemic disease, heart disease, lung disfuction or other diseases that could not tolerate the endoscopic surgery or anesthesia.

• Subject has unadjusted diabetes or high blood pressure

• 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 (2 weeks)

Related Conditions & MeSH terms

• Aneurysm
• Constriction, Pathologic
• Stricture Ureter

Intervention

Device:
• balloon dilatation
The balloon catheter (BD U30) was placed through narrow ureter along the guide wire, and the balloon was pressurized to 25 atm until the "bee waist sign" disappeared on the balloon or the narrow section was seen under the endoscope. Dilation, expansion for 10 min, and then through the endoscope to observe the stenosis of the stenosis (stenosis of the stenosis of the visible adipose tissue)

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

Bromwich E, Coles S, Atchley J, Fairley I, Brown JL, Keoghane SR. A 4-year review of balloon dilation of ureteral strictures in renal allografts. J Endourol. 2006 Dec;20(12):1060-1. — View Citation

Brooks JD, Kavoussi LR, Preminger GM, Schuessler WW, Moore RG. Comparison of open and endourologic approaches to the obstructed ureteropelvic junction. Urology. 1995 Dec;46(6):791-5. — View Citation

Chandhoke PS, Clayman RV, Stone AM, McDougall EM, Buelna T, Hilal N, Chang M, Stegwell MJ. Endopyelotomy and endoureterotomy with the acucise ureteral cutting balloon device: preliminary experience. J Endourol. 1993 Feb;7(1):45-51. — View Citation

Dong H, Peng Y, Li L, Gao X. Prevention strategies for ureteral stricture following ureteroscopic lithotripsy. Asian J Urol. 2018 Apr;5(2):94-100. doi: 10.1016/j.ajur.2017.09.002. Epub 2017 Sep 22. Review. — View Citation

Fasihuddin Q, Abel F, Hasan AT, Shimali M. Effectiveness of endoscopic and open surgical management in benign ureteral strictures. J Pak Med Assoc. 2001 Oct;51(10):351-3. — View Citation

Kramolowsky EV, Tucker RD, Nelson CM. Management of benign ureteral structures: open surgical repair or endoscopic dilation? J Urol. 1989 Feb;141(2):285-6. — View Citation

Liu JS, Hrebinko RL. The use of 2 ipsilateral ureteral stents for relief of ureteral obstruction from extrinsic compression. J Urol. 1998 Jan;159(1):179-81. — View Citation

Lojanapiwat B, Soonthonpun S, Wudhikarn S. Endoscopic treatment of benign ureteral strictures. Asian J Surg. 2002 Apr;25(2):130-3. — View Citation

Ravery V, de la Taille A, Hoffmann P, Moulinier F, Hermieu JF, Delmas V, Boccon-Gibod L. Balloon catheter dilatation in the treatment of ureteral and ureteroenteric stricture. J Endourol. 1998 Aug;12(4):335-40. — View Citation

Tyritzis SI, Wiklund NP. Ureteral strictures revisited…trying to see the light at the end of the tunnel: a comprehensive review. J Endourol. 2015 Feb;29(2):124-36. doi: 10.1089/end.2014.0522. Epub 2014 Oct 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of treatment success in follow-up results after 6 months	The treatment is effective (satisfying any of the following 3 items, that is, the treatment is considered effective) Treatment failure (not satisfying any of the following 3 items is invalid, that is, treatment failure); Retrograde pyelography normal development; ECT shows improvement in renal function on the affected side; CT shows the reduced hydronephrosis.	6 months after surgery
Secondary	Rate of treatment success during the operation	Effective: the balloon is expanded through the stenosis segment, and the diameter of the ureteral tube is obviously thickened after expansion, and the scar tissue is obviously torn, and the surrounding adipose tissue is visible; Failure: The guidewire or balloon cannot pass through the stenotic segment of the ureter and cannot expand the stenosis (the scar tissue is not torn).	Intraoperative