Predictive Factorsfor Final Pathologic Ureteral Sections

NCT03677544 | Completed

• 1 other identifier: PI2017_843_0051
• Study Type: observational
• Target: 748
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urothelial Carcinoma

Keywords

radical systectomy; Ureteral frozen section

Outcome Measures

Primary Outcomes (1)

• preoperative predictive factors

  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.

  2years

Study Arms (2)

no intraoperative FS examination

Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation. procedures were performed between 1980 and 2013

Other: laparoscopic approach with an extended pelvic lymph

intraoperative FS examination

Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation procedures were performed between 2001 and 2013

Other: laparoscopic approach with an extended pelvic lymph

Interventions

laparoscopic approach with an extended pelvic lymph OTHER

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

intraoperative FS examination; no intraoperative FS examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In cohort A, most patients did not have intraoperative FS examination although it was performed in some cases depending on the surgeon's habits (N¼92). All patients had intraoperative FS in the validation cohort B. All cystectomies performed for nononcological purposes were excluded. All patients had nonmetastatic bladder cancer on preoperative computed tomography (CT) scans.

You may qualify if:

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

You may not qualify if:

• patients \< 18 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Fabien Saint, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 17, 2023

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share