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Covered Metal Ureteral Stents in the Treatment of Benign Short Ureteral Stricture

Primary Purpose

Ureteral Stenosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Covered metal ureteral stents
Tandem DJ stents
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Stenosis focused on measuring ureteral stricture, ureteral stent, curative effect

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BSUS patients from January 2023 to January 2024 in Peking University People's Hospital, no gender limitation, aged from 18 to 80, Benign ureteral stricture with definite reason (ureteropelvic junction obstruction, ischemic ureter stenosis caused by surgical separation, ureter partial excision anastomosis stricture after operation, ureteral stricture caused by ureteral endoscope surgery, ureteral stenosis caused by impacted ureteral calculi, ureteral anastomotic stricture after urinary flow diversion, ureteral anastomotic stricture after kidney transplantation, retroperitoneal fibrosis, ureteral stricture caused by trauma, idiopathic ureteral stricture), patients can tolerate anesthesia and surgery and obtain informed consent.

Exclusion Criteria:

  • Patients with hypertonic neurogenic bladder, severe bladder outlet obstruction or bladder capacity less than 50ml, combined with sepsis, incomplete clinical data, failed stent implantation, insufficient indwelling time (< 3 months), postoperative loss of follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CMUS group

    Tandem DJ stent group

    Arm Description

    Balloon dilatation and CMUS insertion were performed in this group.

    Balloon dilatation and Tandem DJ stent insertion were performed in this group.

    Outcomes

    Primary Outcome Measures

    Postoperative Serum Creatinine (SCr)
    It represents for the renal function change after ureteral stent insertion.
    Serum Creatinine (SCr) after stent removal
    It represents for the curative effect of balloon dilatation and ureteral stent.
    Postoperative Renal pelvic width (RPW)
    It represents for the change of hydronephrosis after ureteral stent insertion.
    Renal pelvic width (RPW) after stent removal
    It represents for the curative effect of balloon dilatation and ureteral stent.
    Ureteral stent symptom questionnaire (USSQ)
    USSQ represents for the quality of life of patients with ureteral stents.

    Secondary Outcome Measures

    Complications
    Ureteral stent related complications

    Full Information

    First Posted
    June 13, 2022
    Last Updated
    June 18, 2022
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05430646
    Brief Title
    Covered Metal Ureteral Stents in the Treatment of Benign Short Ureteral Stricture
    Official Title
    Evaluation of Curative Effect of Covered Metal Ureteral Stents in the Endoscopic Treatment of Benign Short Ureteral Stricture: a Prospective Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    BSUS patients were prospectively enrolled in this study, and non-randomly treated with "balloon dilation +CMUS" and "balloon dilation + tandem DJ stent". Perioperative data of the patients were recorded to compare their efficacy and complications, and the ureteral stent symptom questionnaire was used to compare their impact on patients' quality of life. CMUS and tandem DJ stents were removed after ≥3 months of indwelling. After the removal of stents, the patients' serum creatinine and renal pelvis width were followed up to compare their curative effect on BSUS.
    Detailed Description
    The ureteral stricture is caused by various benign and malignant reasons, and then appears hydronephrosis and progressive decline of renal function. Benign short ureteral stenosis (BSUS) especially refers to ureteral stenosis of no more than 2cm in length caused by benign causes such as impacted ureteral stone or endoscopic lithotomy. Currently, BSUS can be treated with laparoscopic or open ureteroplasty, endoscopic balloon dilation or ureterotomy, ureteral stents insertion, or nephrostomy. Since its introduction, covered metal ureteral stent (CMUS) can be used to treat various types of ureteral stricture, achieving a long-term patency rate of more than 80% for BSUS and even curing some patients. It also has fewer complications than a double-J stent (DJ stent). However, there is still a lack of comparative studies on the therapeutic effect and complications of the two treatment methods, namely CMUS after balloon dilation and tandem DJ stent, for BSUS, especially the evaluation of the curative effect of BSUS. Therefore, BSUS patients were prospectively enrolled in this study, and non-randomly treated with "balloon dilation +CMUS" and "balloon dilation + tandem DJ stent". Perioperative data of the patients were recorded to compare their efficacy and complications, and the ureteral stent symptom questionnaire was used to compare their impact on patients' quality of life. CMUS and tandem DJ stents were removed after ≥3 months of indwelling. After the removal of stents, the patients' serum creatinine and renal pelvis width were followed up to compare their curative effect on BSUS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ureteral Stenosis
    Keywords
    ureteral stricture, ureteral stent, curative effect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CMUS group
    Arm Type
    Experimental
    Arm Description
    Balloon dilatation and CMUS insertion were performed in this group.
    Arm Title
    Tandem DJ stent group
    Arm Type
    Active Comparator
    Arm Description
    Balloon dilatation and Tandem DJ stent insertion were performed in this group.
    Intervention Type
    Device
    Intervention Name(s)
    Covered metal ureteral stents
    Intervention Description
    The CMUS is a fully covered, self-expanding, large caliber metal stent. The stent is made of super-elastic nickel-titanium alloy, which maintain lumen patency via providing long-term direct wall support.
    Intervention Type
    Device
    Intervention Name(s)
    Tandem DJ stents
    Intervention Description
    Tandem DJ stents represents for two stents side-by-side, which improves the urine flow by better withstanding the compressive tumoral forces and allowing urine to flow between the stents.
    Primary Outcome Measure Information:
    Title
    Postoperative Serum Creatinine (SCr)
    Description
    It represents for the renal function change after ureteral stent insertion.
    Time Frame
    Postoperative 3-month
    Title
    Serum Creatinine (SCr) after stent removal
    Description
    It represents for the curative effect of balloon dilatation and ureteral stent.
    Time Frame
    Three-month after stent removal
    Title
    Postoperative Renal pelvic width (RPW)
    Description
    It represents for the change of hydronephrosis after ureteral stent insertion.
    Time Frame
    Postoperative 3-month
    Title
    Renal pelvic width (RPW) after stent removal
    Description
    It represents for the curative effect of balloon dilatation and ureteral stent.
    Time Frame
    Three-month after stent removal
    Title
    Ureteral stent symptom questionnaire (USSQ)
    Description
    USSQ represents for the quality of life of patients with ureteral stents.
    Time Frame
    Postoperative 3-month
    Secondary Outcome Measure Information:
    Title
    Complications
    Description
    Ureteral stent related complications
    Time Frame
    Postoperative 3-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BSUS patients from January 2023 to January 2024 in Peking University People's Hospital, no gender limitation, aged from 18 to 80, Benign ureteral stricture with definite reason (ureteropelvic junction obstruction, ischemic ureter stenosis caused by surgical separation, ureter partial excision anastomosis stricture after operation, ureteral stricture caused by ureteral endoscope surgery, ureteral stenosis caused by impacted ureteral calculi, ureteral anastomotic stricture after urinary flow diversion, ureteral anastomotic stricture after kidney transplantation, retroperitoneal fibrosis, ureteral stricture caused by trauma, idiopathic ureteral stricture), patients can tolerate anesthesia and surgery and obtain informed consent. Exclusion Criteria: Patients with hypertonic neurogenic bladder, severe bladder outlet obstruction or bladder capacity less than 50ml, combined with sepsis, incomplete clinical data, failed stent implantation, insufficient indwelling time (< 3 months), postoperative loss of follow-up.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Covered Metal Ureteral Stents in the Treatment of Benign Short Ureteral Stricture

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