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
About this trial
This is an interventional treatment trial for Ureteral Stenosis focused on measuring ureteral stricture, ureteral stent, curative effect
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.
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
NCT ID
NCT05430646
First Posted
June 13, 2022
Last Updated
June 18, 2022
Sponsor
Peking University People's Hospital
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
Learn more about this trial
Covered Metal Ureteral Stents in the Treatment of Benign Short Ureteral Stricture
We'll reach out to this number within 24 hrs