A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture
NCT ID: NCT04021901
Last Updated: 2019-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
420 participants
OBSERVATIONAL
2018-11-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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F21
balloon diameter F21
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)
F24
balloon diameter F24
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
70 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Yinghao Sun
Director of Urology department
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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References
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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.
Lojanapiwat B, Soonthonpun S, Wudhikarn S. Endoscopic treatment of benign ureteral strictures. Asian J Surg. 2002 Apr;25(2):130-3. doi: 10.1016/S1015-9584(09)60160-3.
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. doi: 10.1016/s0022-5347(17)40742-7.
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.
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. doi: 10.1016/S0090-4295(99)80345-8.
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. doi: 10.1089/end.1993.7.45.
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. doi: 10.1089/end.2006.20.1060.
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. doi: 10.1016/s0022-5347(01)64050-3.
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. doi: 10.1089/end.1998.12.335.
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.
Other Identifiers
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SHOT-20181112
Identifier Type: -
Identifier Source: org_study_id
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