Accuracy of Ultrasound Scan in Patients Undergoing Pelvic Exenteration and Laterally Extended Pelvic Resection
Conditions: Gynecologic Cancer, Surgical Procedure, Unspecified
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

 
Accuracy of ultrasound scan in patients undergoing pelvic exenteration and laterally extended pelvic resection – Pre-PEX 
ACCURACY OF ULTRASOUND SCAN IN PATIENTS UNDERGOING PELVIC EXENTERATION AND 
LATERALLY EXTENDED PELVIC RESECTION (Pre-PEX study). 
 
 
 
 
Study protocol 
Version 2.0, 29/05/2020 
 
 
 
 
 
 
 
 
Principal investigator:  
Prof. Antonia Testa 
Policlinico Agostino Gemelli IRCCS 
Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica 
UOC Ginecologia Oncologica 
Largo Agostino Gemelli 8, 00168 
Rome, ITALY 
 
Signature: 
 
 
 
 
 
 
 
 
 

 
Accuracy of ultrasound scan in patients undergoing pelvic exenteration and laterally extended pelvic resection – Pre-PEX 
Responsibles: Dr. Nicolò Bizzarri, Dr.ssa Francesca Moro, Dr. Giuseppe Vizzielli 
 
Promoting Institution 
Policlinico Agostino Gemelli IRCCS 
Dipartimento per la salute della Donna e del Bambino e della Salute Pubblica 
UOC Ginecologia Oncologica 
Largo Agostino Gemelli 8, 00168 
Rome, ITALY 
 
Introduction 
Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in 
diagnosis and staging of gynecologic cancers [1]. In particular, different studies demonstrated the 
accuracy of US in assessing endometrial [2], cervical [3], and ovarian cancer [4] in the primary 
setting. However, the number of studies investigating the role of US in the recurrent setting is 
limited [5-7]. Moreover, there is no evidence in literature exploring the role of US in laterally-
extended pelvic recurrences from gynecologic cancer [8], where the Magnetic Resonance Imaging 
(MRI) scan is still considered the most accurate tool [9]. 
 
Objective of the study 
The objective of the study is to assess the performance of US in patients undergoing pelvic 
exenteration and laterally extended pelvic resection. 
 
The primary objective of the present study is to evaluate the accuracy of US in the assessment of 
pelvic structures involvement in recurrent/persistent gynecologic tumors with disease limited to the 
pelvis. 
Secondary objective is to compare accuracy of US with the accuracy of MRI scan using histology as 
standard. 
 
Type of study 
Prospective, observational, cohort, single center 
 
Inclusion criteria 

 
Accuracy of ultrasound scan in patients undergoing pelvic exenteration and laterally extended pelvic resection – Pre-PEX 
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) [10] 
- 
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 
[8] 
- 
With or without stoma formation 
 
Exclusion criteria 
- 
Radical hysterectomy without lateral resection 
- 
Rectal resection only (posterior exenteration) 
 
Methods 
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 (Supplement 1). 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. 
 
Statistical analysis 

 
Accuracy of ultrasound scan in patients undergoing pelvic exenteration and laterally extended pelvic resection – Pre-PEX 
The sample will be described in its clinical and demographic features using descriptive statistics 
techniques. Quantitative variables will be described using the following measures: minimum, 
maximum, range, mean and standard deviation. Qualitative variables will be summarized with 
absolute and percentage frequency tables. Normality of continuous variables will be checked using 
Kolmogorov-Smirnov test. 
Cohen's Kappa Statistical test will be used to assess concordance between US and histology. 
Statistical analyses will be performed using the Statistical Package for Social Sciences software 
(PASW version 26.0, SPSS Statistic, IBM corp., New York, NY, USA). Two-sided tests will be used and 
the signiﬁcance level was set at p < 0.05. 
 
Sample size 
Given the primary objective and the assuming a degree of disagreement of 15%, setting α=0.01 and 
power=80%, the required sample size is N=85 [11]. 
 
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