| Study characteristics |
| Patient sampling |
Type of study: prospective study.
Consecutive or random sample: neither. |
| Patient characteristics and setting |
Sample size: 179.
Females: 47 (26.3%).
Age: 61 years.
Presentation:
Patients with pancreatic lesions who had undergone EUS and surgical resection with histological confirmation.
Setting: secondary care, Germany. |
| Index tests |
Index test: EUS.
Further details:
Technical specifications: Olympus GF‐UM 3, GF‐UM 20, and GF‐UM 200.
Performed by: gastroenterologist.
Criteria for positive diagnosis: a mass lesion with irregular borders, non‐homogeneous echotexture, and/or loss of vascular interface or obvious vascular involvement, without any signs of chronic pancreatitis in the lesion or the rest of the gland. However, in the presence of obvious chronic pancreatitis, an associated malignancy was suspected if the EUS morphology of the focal lesion suggested involvement of the adjacent structures. |
| Target condition and reference standard(s) |
Target condition: cancerous versus benign.
Reference standard: surgical excision.
Further details:
Technical specifications: not applicable.
Performed by: clinicians.
Criteria for positive diagnosis: not stated. |
| Flow and timing |
Number of indeterminates for whom the results of reference standard were available: not stated.
Number of patients who were excluded from the analysis: 64 (35.8%). |
| Comparative |
|
| Notes |
Possible overlap with Binmoeller 1998a and Binmoeller 1998b; out of 179 patients, only 115 patients with histologically confirmed diagnosis were included. |
| Methodological quality |
| Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
| DOMAIN 1: Patient Selection |
| Was a consecutive or random sample of patients enrolled? |
No |
|
|
| Was a case‐control design avoided? |
Yes |
|
|
| Did the study avoid inappropriate exclusions? |
No |
|
|
| |
|
High |
High |
| DOMAIN 2: Index Test Cancerous versus benign ‐ EUS |
| If a threshold was used, was it pre‐specified? |
Yes |
|
|
| Were the index test results interpreted without knowledge of the results of the reference standard? |
Unclear |
|
|
| |
|
Unclear |
Low |
| DOMAIN 3: Reference Standard |
| Is the reference standards likely to correctly classify the target condition? |
Yes |
|
|
| Were the reference standard results interpreted without knowledge of the results of the index tests? |
Unclear |
|
|
| |
|
Unclear |
Low |
| DOMAIN 4: Flow and Timing |
| Was there an appropriate interval between index test and reference standard? |
Unclear |
|
|
| Did all patients receive the same reference standard? |
Yes |
|
|
| Were all patients included in the analysis? |
No |
|
|
| |
|
High |
|
