Pelvic Exenteration and Laterally Extended Pelvic Resection

Trial Title: Pelvic Exenteration and Laterally Extended Pelvic Resection

NCT ID: NCT06278610

Condition: Gynecologic Cancer
Surgical Procedure, Unspecified

Conditions: Keywords:
pelvic
resection
exenteration

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: PELVIC EXENTERATION
Description: PELVIC EXENTERATION

Other name: Diagnostic Test: For example, imaging,

Other name: Procedure/Surgery

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.

Criteria for eligibility:

Study pop:
Patients undergoing pelvic evisceration and lateral pelvic resection

Sampling method: Non-Probability Sample
Criteria:
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)

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: ANTONIA CARLA Pr TESTA
Email: antoniacarla.testa@policlinicogemelli.it

Contact backup:
Last name: NICOLO' DR BIZZARRI

Phone: 3471771680
Email: nicolo.bizzarri@policlinicogemelli.it

Start date: November 19, 2020

Completion date: January 31, 2025

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06278610