Predictive Factorsfor Final Pathologic Ureteral Sections

Predictive Factorsfor Final Pathologic Ureteral Sections on 700 Radical Cystectomy Specimens: Implicationsforintraoperativefrozensection Decision-making

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03677544

Acronym

CYSTECTOMEN

Enrollment

748

Registered

2018-09-19

Start date

2016-01-01

Completion date

2017-06-01

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Keywords

radical systectomy, Ureteral frozen section

Brief summary

To identify preoperative predictive factors for final ureteral section invasion after radical cystotomie (RC) and to validate significant factors on an external independent cohort. The investigators retrospectively reviewed data of all consecutive RC performed for bladder cancer in 2 high-volume institutions. Clinical, pathological, and follow-up data were collected prospectively and reviewed retrospectively. Pathological evaluation was performed by 2 well-trained uropathologists in each center. Logistic regression analyses were performed to identify predictive factors for final ureteral sections involvement. Significant factors in cohort A were validated in cohort B. Receiver operating curve and area under curve were modeled to evaluate predictive accuracy of the markers

Detailed description

To identify preoperative predictive factors for final ureteral section invasion after radical cystotomie (RC) and to validate significant factors on an external independent cohort. Pathological evaluation was performed by 2 well-trained uropathologists in each center (Y.A. and C.C). The investigators retrospectively reviewed data of all consecutive RC performed for bladder cancer in 2 high-volume institutions. Clinical, pathological, and follow-up data were collected prospectively and reviewed retrospectively. Pathological evaluation was performed by 2 well-trained uropathologists in each center. Logistic regression analyses were performed to identify predictive factors for final ureteral sections involvement. Significant factors in cohort A were validated in cohort B. Receiver operating curve and area under curve were modeled to evaluate predictive accuracy of the markers

Interventions

OTHERlaparoscopic approach with an extended pelvic lymph

Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients \> 18 years * patients reoperative predictive factors for final ureteral section invasion after radical cystectomy

Exclusion criteria

* patients \< 18 years

Design outcomes

Primary

Measure	Time frame	Description
preoperative predictive factors	2years	The objective of this study is to identify preoperative predictive factors for final ureteral section invasion after radical cystectomy (RC) and to validate significant factors on an external independent cohort.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFabien Saint, PU-PH

CHU Amiens-Picardie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026