Pelvic Exenteration and Laterally Extended Pelvic Resection (Pre-PEX)

Accuracy of Ultrasound Scan in Patients Undergoing Pelvic Exenteration and Laterally Extended Pelvic Resection

Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Surgical Procedure, Unspecified
• Intervention / Treatment: Diagnostic test: PELVIC EXENTERATION

Detailed Description

All consecutive patients who are planned to undergo pelvic exenteration or laterally extended pelvic resection at Policlinico Agostino Gemelli IRCCS, will undergo ultrasound scan at the time of the pre-operative anesthetic assessment or the day before the planned surgery. A pre-defined case report form (CRF) will be filled by the ultrasound examiner. The ultrasound characteristics will be compared with the final histology (considered the referral standard).

The ultrasound examinations will be carried out using high-end ultrasound equipment. The frequency of the vaginal probes varied between 5.0 and 9.0 MHz. All examinations will be performed by a specialist obstetrics and gynecology with expertise in gynecologic oncology ultrasound scan. A subjective semi-quantitative assessment of the amount of blood flow within the examined lesion will be made (color score): a score of 1 was recorded when no blood flow could be found; 2 when only minimal/moderate flow could be detected; 3 when very strong blood-flow signals were present.

All patients will undergo pre-operative MRI scan and PET/CT scan. Pelvic exenteration and laterally-extended pelvic resection will be performed with the aim to remove en bloc the recurrent or persistent disease with a free-of-tumor margin.

• Study Type: Observational
• Enrollment (Estimated): 85

Contacts and Locations

• Study Contact: Name: ANTONIA CARLA TESTA, PROF; Phone Number: 0630156399; Email: antoniacarla.testa@policlinicogemelli.it
• Study Contact Backup: Name: NICOLO' DR BIZZARRI; Phone Number: 3471771680; Email: nicolo.bizzarri@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: NICOLO' DR BIZZARRI; Phone Number: 3471771680; Email: nicolo.bizzarri@policlinicogemelli.it
    • Contact: ANTONIA CARLA Pr TESTA; Email: antoniacarla.testa@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pelvic evisceration and lateral pelvic resection

Description

Inclusion Criteria:

All consecutive patients with histologically-proven recurrent or persistent gynecological cancer who are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and with palliative intent.

• Anterior/total pelvic exenteration
• Laterally extended endopelvic resection (LEER)
• Laterally extended pelvic resection (LEPR) is defined as an en bloc lateral resection of a pelvic tumor involving sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure
• With or without stoma formation

Exclusion Criteria:

• Radical hysterectomy without lateral resection
• Rectal resection only (posterior exenteration)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pelvic exenteration resection.	The accuracy of US in the assessment of pelvic structures involvement in recurrent/persistent gynecologic tumors with disease limited to the pelvis.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of US with the accuracy of MRI	To compare accuracy of US with the accuracy of MRI scan using histology as standard.	1 week

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: ANTONIA CARLA TESTA, PROF, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: resection; pelvic; exenteration
• Other Study ID Numbers: 3612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No