Supplementary Digital Content

Appendix Table 1: Study Inclusion Criteria for Comparative Accuracy Data

Category / Inclusion Criterion /
Publication criteria / Full-length articles, data not included in other articles, English, published since 1/1/2000
Studydesign
criteria / For any KQs comparing two or more tests, the study must have compared both tests to a reference standard. The reference standard must not have been defined by either imaging test being assessed.
Patient criteria / Study must have reported data obtained from groups of patients in which at least 85 percent of the patients were from one of the patient populations of interest. If a study reported multiple populations, it must have reported data separately for one or more of the populations of interest. Adults. At least 85 percent of patients must have been aged 18 years or older, or data must have been reported separately for those aged 18 years or older. Studies of screening, diagnosing, or staging primary pancreatic adenocarcinoma were included. Testing for recurrent pancreatic cancer was excluded. Data on imaging tests performed after any form of treatment (e.g., neoadjuvant chemotherapy) were excluded, but pretreatment imaging data were considered.
Test criteria / Only studies of the imaging tests of interest were included. Studies of computed tomography (CT) that did not explicitly state that (or it could not be determined that) CT was multidetector CT were assumed to be so. Given our publication date criterion of 2000 and later, we believe it safe to assume that CT performed in such studies was multidetector.
Data criteria / At least 10 patients per imaging test. Sufficient information for one to calculate both sensitivity and specificity, along with corresponding confidence intervals. The reported data must have included at least 50 percent of the patients who had initially enrolled in the study. Studies that reported data by tumor (e.g., x percent of pancreatic adenocarcinoma tumors were correctly detected) instead of by patient (e.g., x percent of enrolled patients were correctly given a diagnosis of pancreatic adenocarcinoma) were not excluded for this difference. However, the tumor-based data was separated from the patient-based data because they measure different types of accuracy.

Appendix Table 2: Risk of Bias Items for Comparative Accuracy

Number / Item
1 / Did the study enroll all, consecutive, or a random sample of patients?
2 / Was the study unaffected by spectrum bias (e.g., patients with known status before the study, or patients selected for being difficult to diagnose/stage)?
3 / Was prior experience with the test (technicians, readers) similar for the two imaging tests being compared in the study?
4 / Were the imaging tests performed within one month of each other (to avoid the possibility that the patient’s true condition changed between tests)?
5 / Was knowledge of the other test complementary (either both tests were read with knowledge of the other results, or neither test was read with knowledge of the other)?
6 / Did the interpreters have the same other information available at the time of interpretation for the two imaging tests (other clinical information, 3rdtest results)?
7 / Was each test’s accuracy measuring using the same reference standard (or a similar proportion of patients who underwent different reference standards such as clinical follow-up and surgical findings)?
8 / Were readers of both tests of interest blinded to the results of the reference standard (or the reference standard was unknowable until after the tests were read)?
9 / Were the people determining the reference standard unaware of the diagnostic test results?

We defined LOW risk of bias as a study that has a YES for the six boldfaced items above (#2, and #4 through #8). We defined HIGH risk of bias as a study that has a NO (or Not Reported) for these six items. We defined MEDIUM risk of bias a study that meets neither the LOW nor the HIGH criteria.

Appendix Table 3: Study Designs and Patients

Study
Location / Imaging
Dates / Type
Risk of Bias / NPatients
(F/M) / Mean Age
Age Range / Specific Final Diagnoses / Comment /
Fang et al.
201234
China / Nov. 2008–
Aug.2010 / Prospective
Low / 57
(46/11) / 57.9 / 43 panc. ductal adenoca. of the head,
14panc.ductal adenoca. of the body/tail / The study also included some patients with
periampullary cancer, but data were provided
specifically for pancreatic cancer.
Patient characteristics are based on all enrolled.
Herrmann et al.
201227
Germany / Sept. 2008,
April2009 / Prospective
Moderate / 44
(16/28) / Median 65
34–86
Tellez-Avila et al.
201225
Mexico / March 2005–
March2010 / Prospective
Moderate / 50
(27/23) / 61 ± 11.5 / After surgery, histological vascular invasion was
demonstrated in 18 patients, vein invasion in 11,
and arterial invasion in 9. / 17/19 patients with adequate tissue samples by EUS.
Tissue sampling not attempted in 31 patients.
Holzapfel et al.
201120
Germany / NR / Prospective
Low / 31
(15/16) / 61.4
32–84 / 23 panc. ductal adenoca., 1 acinar cell ca.,
1neuroendocrine ca., 1 benign IPMN,
1malignantIPMN, 1 cholangiocarcinoma,
1papillary ca., 2 focal chronic pancreatitis
Koelblinger et al.
201114
Austria / Sept. 2006–
Nov. 2007 / Prospective
Low / 89
(48/41) / 65.5 / 43 panc. adenoca., 4 ampullary ca., 7 metastases,
1neuroendocrine tumor, 1 cystadenoma, 9cystictumor,
4 inflammatory pseudotumor, 1focal steatosis, 26 normal
Motosugi et al.
201113
Japan / March 2008–
June2010 / Retrospective
Low / 100
(47/53) / Women
68.2 ± 10.6
Men
67.5 ± 10.6 / 54 panc. ca., 14 biliary stone and/or adenomyomatosis
of the gallbladder, 10 biliary ca.,4 gallbladder ca.,
3 liver metastasis from colon ca., 6 intraductal
papillary mucinous neoplasm of the pancreas,
9 no evidence of disease in the abdomen
Rao et al.
201111
China / NR / Retrospective
Moderate / 46
(25/21) / 57
22–81 / 18 panc. ductal adenoca., 13 neuroendocrine tumor,
8 metastases (primary cancer not reported but
probably panc. cancer), 5 solid pseudopapillary tumor,
2 intrapanc. accessory spleen
Shami et al.
201132
USA / NR / Prospective
Moderate / 127
(56/71) / 66 / All had panc. cancer; specific diagnoses not reported
Takakura et al.
201112
Japan / Oct. 2007–
Sept. 2009 / NR
Low / 83
(22/61) / Mean not reported. Range 37–91 / Panc. cancer (presumably adenoca.), IPMN,
cholangio (bile duct), adenoca. of duodenum
(papilla of Vater) (counts not reported)
Imai et al.
201021
Japan / Aug. 2005–
July2008 / Retrospective
Moderate / 119
(61/58) / 65
32–85 / 79 panc. adenoca. head only, 23 panc. adenoca. body only,
5 panc. adenoca. tail only, 1 panc. adenoca. head + body,
10 panc. adenoca. body + tail,
1 panc. adenoca. head+body+tail / Comparative accuracy data only reported for the
69/119 who received all three imaging tests:
CT,MRI, PET.
Lee et al.
201018
South Korea / Jan. 2003–
June2005 / Retrospective
Low / 56
(26/30) / 60.9
37–76 / 56 panc. adenoca.
Kauhanen et al.
200915
Finland / Sept. 2006–
Oct. 2007 / Prospective
Low / 38
(19/19) / 62.6 / 17 panc. adenoca., 3 neuroendocrine tumor,
4 chronic pancreatitis, 5 benign cystic lesion,
1 malignant cystic lesion, 2 fibrosis, 6normalpancreas
Farma et al.
200831
USA / Jan. 2006–
Dec. 2007 / Retrospective
Moderate / 82
(39/43) / Median 69
24–88 / 65 panc. cancer, 17 IPMNs
Saif et al.
200828
USA / May 2003–
March2004 / Prospective
Low / 12
(3/9) / 61
43–74 / 11 malignant panc. adenoca., 1 benign
Schick et al.
200833
Germany / July 2005–
Feb.2007 / Prospective
Moderate / 46
(14/32) / 61.7
31 to 87 / 22 ductal adenoca., 1 adenoca. of the ampulla of Vater,
1neuroendocrine ca., 1 cholangiocellular ca.,
1 metastasis from breast cancer,
1 GIST in duodenum, 14 chronic pancreatitis,
2 pseudocyst with blood/necrotic tissue,
2 bile duct stenosis, 1 focal tuberculosis
Casneuf et al.
200726
Belgium / Oct. 2004–
April2006 / Prospective
Moderate / 34
(16/18) / 61 / 18 adenoca., 4 neuroendocrine tumor,
3 unknown panc. tumor, 6 pancreatitis, 3cystadenoma. / Age was estimated by the EPC based on
separately-reported medians of 63 for the
25 positives and 58 for the 9 negatives.
The study reported another 12 patients who
were included for assessment of recurrence;
these patients’ data were not included.
Tamm et al.
200722
USA / NR / Retrospective
Moderate / 117
(54/63) / 69 / 95 adenoca., 2 extrahepatic cholangiocarcinoma,
1 intraductal papillary mucinous neoplasm without a
cystic component, 1 ampullary ca.,
10 chronic pancreatitis,
1 benign panc. duct stricture,
3 benign common bile duct stricture, 1choledochal cyst
Mehmet Ertuk et al.
200616
Japan / Jan. 2003–
Oct.2004 / Retrospective
Moderate / 45
(25/20) / 67.4
42–85 / 14 head adenoca., 6 body adenoca.,
4 tail adenoca.,
3 elevated CA 19-9 but no adenoca.,
5 acute pancreatitis, 7 chronic pancreatitis, 6IPMN. / Age calculated based on weighted average of
reported mean ages of positives and negatives.
Heinrich et al.
200529
Switzerland, Austria / June 2001–
April 2004 / Prospective
Moderate / 59
(29/30) / Median 61
40–80 / 43 ductal adenoca., 1 acinuscell ca., 1neuroendocrine ca.,
1 metastasis, 1 serous microcystic adenoma,
1 high-grade epithelial dysplasia,
1 focal tuberculosis,
3 chronic pancreatitis (pseudotumor);
7 no definitive histologic diagnosis was available
Agarwal et al.
200424
USA / Nov. 2000–
Nov.2001 / Retrospective
Moderate / 81
(41/40) / 66.4 ± 10.5 / 71 malignant and 10 benign.
Of the 71 malignant tumors: 58 were located in the
panc. head, 5 in the uncinate process, and 8in the
neck, body or tail of the pancreas)
DeWitt et al.
200423
USA / July 2000–
Oct.2002 / Prospective
Low / 104
(45/59) / 64 / 28 unresectable panc. ca, determined after surgery,
25 resectable panc. ca., 5 chronic pancreatitis,
1 benign intraductal papillary mucinous tumor,
1 macrocystic serious [sic] cystadenoma, 1 benign
neuroendocrine tumor, 1 accessory spleen,
1 ampullary cancer, 9 benign resectable focal panc.
masses without vascular invasion,
26 panc. adenoca. determined without surgery,
1 neuroendocrine ca. determined without surgery,
2 suspected unresectable gall bladder ca. or hepatoma,
3 no mass, 1 suspected liver abscess,
8 benign disease
Lemke et al.
200430
Germany / Aug. 1999–
Dec.2001 / Prospective
Moderate / 104
(53/51) / Median 64
23–84 / 57 adenoca., 5 ca. of papilla of Vater, 1bileductca.,
1 neuroendocrine tumor, 28chronic pancreatitis,
5 papillary adenoma, 3otherbenign lesions / Final diagnoses: 53 surgical resection,
25exploratory surgery, 16 percutaneous
needleaspiration biopsy, 10 clinical follow-up
Soriano et al.
200419
Spain / Oct. 1995–
March2000 / Prospective
Moderate / 62
(29/33) / 65 / 42 pancreas head ca., 6 pancreas body ca.,
4pancreas tail ca., 10 ampullary ca.
Rieber et al.
200017
Germany / NR / Prospective
Moderate / 20
6/14) / 62
34–88 / 8 panc. adenoca., 10 chronic pancreatitis,
2stenosing papillitis

No authors reported funding from device or drug manufacturers or any other potential conflicts of interest.

Adenoca.–adenoca.,ca.–carcinoma, NR–not reported panc.–pancreatic

Appendix Table 4: Study Results

Study / Clinical Purpose / Test 1
Sensitivity / Test 1
Specificity / Test 2
Sensitivity / Test 2
Specificity / Comments /
CT vs. MRI / CT / MRI
Koelblinger 201114 / Diagnosis / 98% (42/43) / 96.2% (25/26) / 98% (42/43) / 92% (24/26) / Reader 1
93% (40/43) / 96.2% (25/26) / 95% (41/43) / 96% (25/26) / Reader 2
Motosugi 201113 / Diagnosis / 94% (51/54) / 97.8% (45/46) / 96% (52/54) / 98% (45/46) / Reader 1
96% (52/54) / 97.8% (45/46) / 98% (53/54) / 98% (45/46) / Reader 2
96% (52/54) / 97.8% (45/46) / 98% (53/54) / 98% (45/46) / Reader 3
Rao 201111 / Diagnosis / 84% (21/25) / 94.1% (16/17) / 88% (7/8) / 50% (4/8) / Reader 1
96% (24/25) / 88.2% (15/17) / 100% (8/8) / 63% (5/8) / Reader 2
Takakura 201112 / Diagnosis / 82% (27/33) / 88% (44/50) / 79% (26/33) / 88% (44/50) / Average of 4 readers’ results
Kauhanen 200915 / Diagnosis / 85% (17/20) / 66.7% (12/18) / 85% (17/20) / 72% (13/18)
Mehmet Ertuk 200616 / Diagnosis / 83% (20/24) / 85.7% (18/21) / 83% (20/24) / 100% (21/21) / Reader 1
83% (20/24) / 90.5% (19/21) / 83% (20/24) / 95% (20/21) / Reader 2
83% (20/24) / 90.5% (19/21) / 83% (20/24) / 100% (21/21) / Reader 3
Rieber 200017 / Diagnosis / 100% (8/8) / 75% (9/12) / 88% (7/8) / 75% (9/12)
Koelblinger 201114 / Resectability / 75% (6/8) / 86.7% (13/15) / 75% (6/8) / 93% (14/15) / Reader 1
63% (5/8) / 86.7% (13/15) / 50% (4/8) / 93% (14/15) / Reader 2
Lee 201018 / Resectability / 65% (11/17) / 89.7% (35/39) / 41% (7/17) / 90% (35/39) / Reader 1
59% (10/17) / 89.7% (35/39) / 29% (5/17) / 90% (35/39) / Reader 2
Soriano 200419 / T staging / Correct 73% (43/59)
Overstaged 2% (1/59)
Understaged 25% (15/59) / Correct 62% (37/59)
Overstaged 5% (3/59)
Understaged 32% (19/59)
Soriano 200419 / N staging / 38% (9/24) / 79.4% (27/34) / 15% (3/20) / 93% (28/30)
Holzapfel 201120 / M staging / 53% (8/15) / 81% (17/21) / 87% (13/15) / 95% (42/44) / Sensitivity data reported per-lesion.