Pelvic Exenteration and Laterally Extended Pelvic Resection

Recruiting

• Conditions: Gynecologic Cancer; Surgical Procedure, Unspecified

• Registration Number: NCT06278610
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

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 Timeline

• Study Start: 2020-11-19
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
accuracy of US with the accuracy of MRI	1 week	To compare accuracy of US with the accuracy of MRI scan using histology as standard.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy