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

NCT04021901 | Unknown

• 1 other identifier: SHOT-20181112
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stricture Ureter

Keywords

benign ureteral stricture; balloon dilatation

Outcome Measures

Primary Outcomes (1)

• 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) 1. Retrograde pyelography normal development; 2. ECT shows improvement in renal function on the affected side; 3. CT shows the reduced hydronephrosis.

  6 months after surgery

Secondary Outcomes (1)

• Rate of treatment success during the operation

  Intraoperative

Study Arms (2)

F21

balloon diameter F21

Device: balloon dilatation

F24

balloon diameter F24

Device: balloon dilatation

Interventions

balloon dilatation DEVICE

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)

F21; F24

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with ureteral stricture or atresia by enhanced CTU, intravenous pyelography or retrograde pyelography, and ureteral stenosis length is ≤ 2cm (single or multiple segments)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 29736371 BACKGROUND

• 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.

  PMID: 12376232 BACKGROUND

• 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.

  PMID: 2913345 BACKGROUND

• 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.

  PMID: 11768936 BACKGROUND

• 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.

  PMID: 7502417 BACKGROUND

• 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.

  PMID: 8481721 BACKGROUND

• 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.

  PMID: 17206902 BACKGROUND

• 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.

  PMID: 9400466 BACKGROUND

• 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.

  PMID: 9726399 BACKGROUND

• 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.

  PMID: 25100183 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Urology department

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

CN (1)