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

July 14, 2019 updated by: Yinghao Sun, Changhai Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
        • Contact:
          • Li Ling, MD
          • Phone Number: 0086-18019766513
          • Email: ejdll@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
F21
balloon diameter F21
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)
F24
balloon diameter F24
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of treatment success in follow-up results after 6 months
Time Frame: 6 months after surgery

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of treatment success during the operation
Time Frame: Intraoperative
  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).
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHOT-20181112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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