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Stricture UreterNCT04021901

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

An observational study of Stricture Ureter, run by Changhai Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Stricture Ureter
What is being tested?
balloon dilatation
Type of treatment
Medical device
How many people
420 participants
Where
1 siteChina
Study dates
1 Nov 2018to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • • 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)

Who cannot join

  • • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Gao Xiaofeng, MD, 0086-13601600968, gxfdoc@hotmail.com

    Li Ling, MD, 0086-18019766513, ejdll@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Multicenter Study of Balloon Dilatation for the Treatment of Benign

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.

Read the detailed 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.

Being tested
balloon dilatation
Keywords
benign ureteral stricture, balloon dilatation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • balloon dilatationDevice

    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)

Study groups in NCT04021901
Study groupRoleWhat they receive
F21balloon diameter F21
Receives: Device: balloon dilatation
F24balloon diameter F24
Receives: Device: balloon dilatation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after surgery

Secondary outcomes (1)

  1. Rate of treatment success during the operation

    1. 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;
    2. 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).

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start1 Nov 2018
  3. Primary completionNov 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021901
Sponsor's protocol ID
SHOT-20181112
Status last verified
Jul 2019
First submitted
12 Jul 2019
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29736371

  • 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.

    PubMed 12376232

  • 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.

    PubMed 2913345

  • 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.

    PubMed 11768936

  • 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.

    PubMed 7502417

  • 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.

    PubMed 8481721

  • 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.

    PubMed 17206902

  • 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.

    PubMed 9400466

  • 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.

    PubMed 9726399

  • 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.

    PubMed 25100183

Questions about this trial

What is this clinical trial studying?

An observational study of Stricture Ureter, run by Changhai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of treatment success in follow-up results after 6 months (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021901, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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