Percutaneous Nephroscopic Treatment of Parapelvic Cysts | NCT05504512

Studies
Percutaneous Nephroscopic Treatment of Parapelvic Cysts

NCT05504512

Sponsor

Xiangya Hospital of Central South University

Status

Unknown status

Last Update Posted

Oct 24, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Kidney Stone
Parapelvic Cyst
Kidney Diseases
Recurrence

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2022Estimated

Primary Completion Date

Nov 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Aug 14, 2022

First Submission Date that Met QC Criteria

Aug 14, 2022

First Posted Date

Aug 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2022

Last Update Posted Date

Oct 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background of the project: The surgical treatment of parapelvic cysts is currently less researched and there is no gold standard for surgery. Previously, in percutaneous nephrolithotomy, we found that fenestration and fenestration drainage in the simultaneous treatment of pararenal pelvis cysts under nephroscopic nephroscopic surgery has clear curative effect, less trauma, and quicker recovery.

Objective: To clarify the safety, efficacy and long-term efficacy of percutaneous nephroscopy in the treatment of parapelvic cysts.

Nature: Retrospective case cohort study. Basic research process: Retrospective collection of cases in our hospital who underwent percutaneous nephroscopy for the treatment of parapelvic cysts, and comparison of preoperative and postoperative cyst size changes and long-term efficacy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parapelvic cyst			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Parapelvic cyst

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cyst size	Cyst maximum plane diameter	At least 1 year after percutaneous nephroscopy for parapelvic cysts

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Has undergone percutaneous nephroscopic surgery for parapelvic cysts
Ability to receive study follow-up

Exclusion Criteria:

Patient refuses or is unable to give consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have undergone percutaneous nephroscopic surgery for parapelvic cysts

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hequn Chen, M.D.	Contact	13908475808		chenhequnxy@126.com

Overall Officials

Name	Affiliation	Role
Yu Cui, M.D.	Xiangya Hospital of Central South University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiangya hospital of central south university		Changsha	Hunan		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D007674	Kidney Diseases
D012008	Recurrence

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided