Elsevier

The Lancet Oncology

Volume 9, Issue 2, February 2008, Pages 124-131
The Lancet Oncology

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Effect of quality of gynaecological ultrasonography on management of patients with suspected ovarian cancer: a randomised controlled trial

https://doi.org/10.1016/S1470-2045(08)70005-6Get rights and content

Summary

Background

The diagnostic accuracy of ultrasonography for differentiating between benign and malignant adnexal masses is proportional to the expertise of the operator. However, we do not know whether improved diagnostic accuracy will affect the management of these tumours. We assessed the effect of the quality of gynaecological ultrasonography on the management of patients with suspected ovarian cancer in a randomised controlled trial.

Methods

165 patients who were referred to the regional gynaecological cancer centre at Guy's and St Thomas' NHS Foundation Trust (London, UK), between June 7, 2004, and April 23, 2006, with suspected adnexal tumours met the inclusion criteria. Of these, 150 patients were randomly assigned to either level II (routine) ultrasonography (n=73) or to level III (expert) ultrasonography (n=77). The primary endpoint was the number of major surgical staging procedures (including a laparotomy and at least an oophorectomy and omental biopsy) in each group of the study. Secondary endpoints were: total number of surgical procedures; number of minimally invasive procedures (eg, operative laparoscopy or ultrasonography-guided cyst aspiration); number of additional diagnostic tests (eg, CT or laparoscopy); number of follow-up scans; diagnostic accuracy of level II and level III ultrasonography; and duration of hospital stay. All analyses were by intention to treat. This study is registered on the Current Controlled Trials website http://www.controlled-trials.com/mrct/trial/230201/ISRCTN02631195.

Findings

More major surgical staging procedures for suspected ovarian cancer were done in the level II group than in the level III group of the study (27 of 73 [37%] vs 17 of 77 [22%], respectively; difference between groups 15% [95% CI 0–29]; RR 1·68 [1·00–2·81]; p=0·049). The total number of surgical procedures was similar between the two groups: 35 of 73 (48%) in the level II group and 33 of 77 (43%) in the level III group (RR 1·12 [0·79–1·59]; p=0·53). The median duration of hospital stay for patients who were operated on was 6 days (range 3–13) in the level II group and 5 days (range 1–9) in the level III group (p=0·01). A likely histological diagnosis was provided to clinicians after ultrasonography for 76 of 77 (99%) patients in the level III group compared with only 38 of 73 (52%) patients in the level II group. 18 of 150 (12%) patients recruited were eventually diagnosed with ovarian malignancy. The sensitivity and specificity of ultrasonography was 2 of 5 (40%; [95% CI 6·5–84·6]) and 10 of 10 (100%; [34–100]), respectively, in the level II group and 7 of 8 (88%; [47–98]) and 27 of 28 (96%; [82–99]), respectively, in the level III group.

Interpretation

Improved quality of ultrasonography has a measurable effect on the management of patients with suspected ovarian cancer in a tertiary gynaecology cancer centre, and results in a significant decrease in the number of major staging procedures and a shorter inpatient hospital stay.

Introduction

A clinical diagnosis of an adnexal tumour is often made in patients who complain of abdominal swelling and pelvic pain. These tumours can also be noted incidentally during bimanual pelvic examination or on ultrasonography, when an examination is done for early pregnancy complications or other gynaecological symptoms.1, 2, 3, 4

The differential diagnosis of adnexal masses includes ovarian cancer and patients are often offered additional investigations, such as tumour-marker tests, to clarify the nature of the tumour.5 However, the nature of adnexal tumours often remains uncertain despite several tests and, as a result, many patients undergo major surgery because of the fear of missing an ovarian cancer.6

Ultrasonography is a sensitive method for the detection of adnexal abnormalities and is routinely used for the assessment of patients with various gynaecological complaints. The ability of ultrasonography to establish the nature of an adnexal tumour is variable and depends mainly on the experience and skill of the operator.7, 8 Studies have shown that, when carried out by experts (known as level III ultrasonography), gynaecological ultrasonography can distinguish between benign and malignant adnexal tumours with an accuracy of 164 of 173 (95%) tumours.7 The accuracy of routine ultrasonography (known as level II ultrasonography), which is usually done by less experienced operators, is likely to be lower.8 The best survival for patients with ovarian cancer is achieved when treatment is organised and carried out by gynaecological oncologists who work in cancer centres.9 However, patients with asymptomatic benign tumours can be managed expectantly3, 10, 11 or by minimally invasive surgery if symptomatic.12, 13 These procedures can be safely undertaken by general gynaecologists in local hospitals.

In the UK, most patients with suspected or confirmed adnexal masses are referred to rapid-access gynaecological oncology clinics for detailed investigations and treatment. Most gynaecological ultrasonography examinations, both in local hospitals and tertiary cancer centres, are done by sonographers who are usually trained to do level II14 ultrasonography. Before this study, patients who attended our regional gynaecological cancer centre (Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK) with an adnexal mass and had non-diagnostic level II ultrasonography, were subsequently referred for level III scans14 at our unit. Although level III scans were not incorporated in the protocol of the regional gynaecological cancer centre, a retrospective audit showed an improved accuracy of level III scanning for the diagnosis of ovarian cancers compared with level II scans.

The aim of this study was to assess whether the improved accuracy of level III ultrasonography has a measurable effect on the management of patients with adnexal masses compared with routine level II ultrasonography.

Section snippets

Methods

We did a prospective randomised controlled study, which took place at Guy's and St Thomas' NHS Foundation Trust and at King's College Hospital NHS Foundation Trust (London, UK). The study was approved by the ethics committee and the research and development committee at both hospitals.

Results

The study was done between May 31, 2004, and February 15, 2007. 165 patients met the inclusion criteria, but ten patients declined participation and five were excluded because they needed urgent surgical treatment (figure). The remaining 150 patients were randomised into the study, with 77 randomly assigned to level III ultrasonography and 73 randomly assigned to level II ultrasonography. The demographic data of the patients in both groups of the study are presented in table 1. The two groups

Discussion

This study shows that the quality of gynaecological ultrasonography has a significant effect on the choices made by gynaecological oncologists in the management of patients with suspected ovarian cancer. The number of major surgical staging procedures for presumed ovarian cancer was significantly lower after level III (expert) ultrasonography compared with after a routine scan (level II) done by a non-specialist. This finding is likely to be the consequence of the greatly increased proportion

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