Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial).

BACKGROUND: Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. METHODS/DESIGN: In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described. CONCLUSION: The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life. TRIAL REGISTRATION NUMBER: Netherlands Trial Register (NTR): NTR2579.

Ultrasonography and clinical observation in women with suspected acute appendicitis: a prospective cohort study.

BACKGROUNDS/AIMS: It was the aim of this study to evaluate the role of ultrasonography (US) and clinical observation in non-pregnant women of reproductive age with suspected appendicitis. METHODS: In a prospective cohort study, US was performed in 234 women with suspected appendicitis. Based on US findings and clinical assessment, 3 patient categories were established. Group A: unequivocal signs--laparoscopy (regardless of US results); group B: equivocalsigns--positive US--laparoscopy; group C: equivocal signs--negative US--observation. US results were compared with surgery, observation and follow-up as the reference standard. RESULTS: The percentages of macroscopically infected appendices at laparoscopy in groups A, B and C were 76, 55 and 5%, respectively. Group A: US was false negative in 27 of 128 women (21%) and false positive in 12 of 40 women (30%). Group B plus C: US was false negative in 3 of 9 women (33%) and false positive in 5 of 57 women (9%). Forty-six of 55 patients (84%) completed observation. CONCLUSION: Because of a high false-negative rate, US as a sole imaging tool is of limited value both in women with unequivocal and equivocal signs of appendicitis. Observation is safe in women with equivocal signs of appendicitis.

Improving the false-negative rate of CT in acute appendicitis-Reassessment of CT images by body imaging radiologists: a blinded prospective study.

PURPOSE: To compare the accuracy of computed tomography (CT) analyzed by individual radiology staff members and body imaging radiologists in a non-academic teaching hospital for the diagnosis of acute appendicitis. PATIENTS AND METHODS: In a prospective study 199 patients with suspected acute appendicitis were examined with unenhanced CT. CT images were pre-operatively analyzed by one of the 12 members of the radiology staff. In a later stage two body imaging radiologist reassessed all CT images without knowledge of the surgical findings and without knowledge of the primary CT diagnosis. The results, independently reported, were correlated with surgical and histopathologic findings. RESULTS: In 132 patients (66%) acute appendicitis was found at surgery, in 67 patients (34%) a normal appendix was found. The sensitivity of the primary CT analysis and of the reassessment was 76% and 88%, respectively; the specificity was 84% and 87%; the positive predictive value was 90% and 93%; the negative predictive value was 64% and 78%; and the accuracy was 78% and 87%. CONCLUSION: Reassessment of CT images for acute appendicitis by body imaging radiologists results in a significant improvement of sensitivity, negative predictive value and accuracy. To prevent false-negative interpretation of CT images in acute appendicitis the expertise of the attending radiologist should be considered.

[The use of imaging in the case of suspected acute appendicitis: opinion of Dutch surgeons]. / Beeldvormend onderzoek bij vermoeden van appendicitis acuta: mening van chirurgen in Nederland.

OBJECTIVE: To gauge the opinion of Dutch surgeons concerning the use of ultrasound and CT in the case of a suspected acute appendicitis. DESIGN: Written survey. METHOD: All 1020 members of the Association of the Surgeons of the Netherlands received a questionnaire with 8 statements concerning the diagnosis of acute appendicitis. The statements could be answered with 'agree', 'disagree', or 'no opinion'. RESULTS: The questionnaire was returned by 439 members (43%). A majority (64%) of these respondents established the diagnosis acute appendicitis on the basis of clinical symptoms, whereas a minority (22%) routinely performed ultrasound. For a classical presentation, 45% of the respondents thought ultrasound was indicated; for less than 3 classical symptoms, 70% of the respondents thought ultrasound was indicated. For women of fertile age, 74% of the respondents thought ultrasound was indicated. Approximately half (46%) of the surgeons always had access to a radiologist who could reliably perform ultrasound imaging, whereas 34% did not. The combination of ultrasound and CT was considered to be a reliable diagnostic procedure by 74% of the surgeons. CONCLUSION: The majority of the surgeons considered acute appendicitis to be mainly a clinical diagnosis.

Improving diagnosis of acute appendicitis: results of a diagnostic pathway with standard use of ultrasonography followed by selective use of CT.

BACKGROUND: Preoperative imaging has been demonstrated to improve diagnostic accuracy in appendicitis. This prospective study assessed the accuracy of a diagnostic pathway in acute appendicitis using ultrasonography (US) and complementary contrast-enhanced multidetector CT in a general community teaching hospital. STUDY DESIGN: One hundred fifty-one patients with clinically suspected appendicitis followed the designed protocol: patients underwent operations after a primary performed positive US (graded compression technique) or after complementary CT (contrast-enhanced multidetector CT) when US was negative or inconclusive. Patients with positive CT findings underwent operations. When CT was negative for appendicitis, they were admitted for observation. Results of US and CT were correlated with surgical findings, histopathology, and followup. RESULTS: Positive US was confirmed at operation in 71 of 79 patients and positive CT was confirmed in all 21 patients. All 39 patients with negative CT findings recovered without operations. The negative appendicitis rate was 8% and perforation rate was 9%. The sensitivity and specificity of US was 77% and 86%, respectively. The sensitivity and specificity of CT was both 100%. The sensitivity and specificity of the whole diagnostic pathway was 100% and 86%, respectively. CONCLUSIONS: A diagnostic pathway using primary graded compression US and complementary multidetector CT in a general community teaching hospital yields a high diagnostic accuracy for acute appendicitis without adverse events from delay in treatment. Although US is less accurate than CT, it can be used as a primary imaging modality, avoiding the disadvantages of CT. For those patients with negative US and CT findings, observation is safe.

Comparison of CT and sonography in the diagnosis of acute appendicitis: a blinded prospective study.

OBJECTIVE: Our objective was to compare the accuracy of CT and sonography in a general community teaching hospital for the diagnosis of acute appendicitis in patients with suspected acute appendicitis. SUBJECTS AND METHODS. In this prospective study, 199 consecutive patients with clinical signs and symptoms of acute appendicitis were examined with sonography (graded compression technique) and CT (focused unenhanced single-detector helical CT [5-mm section thickness]. CT was performed from the L2 vertebral body to the pubic symphysis, and no patients were given oral, rectal, or IV contrast medium. The primary sonographic criterion for diagnosing acute appendicitis was an incompressible appendix with a transverse outer diameter of 6 mm or larger with incompressible periappendicular inflamed fat with or without an appendicolith. The primary CT criterion for diagnosing acute appendicitis was the identification of an appendix with a transverse outer diameter of 6 mm or larger with associated periappendiceal inflammatory changes. The results, independently reported, were correlated with surgical and histopathologic findings. RESULTS: One hundred thirty-two patients had acute appendicitis at surgery, and 67 patients did not. The sensitivity of CT and sonography was 76% and 79%, respectively; the specificity was 83% and 78%; the accuracy was 78% and 78%; the positive predictive value was 90% and 87%; and the negative predictive value was 64% and 65%. CONCLUSION: Unenhanced focused single-detector helical CT and graded compression sonography performed in a general community teaching hospital by both body imaging radiologists and general radiology staff members have a similar accuracy for the diagnosis of acute appendicitis.