Accepted Manuscript The Sensitivity of Narrow Band Imaging Compared to White Light Imaging for the Detection of Endometriosis Fermin F. Barrueto, M.D., Kevin M. Audlin, M.D., Lisa Gallicchio, Ph.D., Charles Miller, M.D., Ryan MacDonald, Ph.D., Edgar Alonsozana, M.D., Mary Johnston, Kathy J. Helzlsouer, M.D., M.H.S. PII:
S1553-4650(15)00289-7
DOI:
10.1016/j.jmig.2015.04.005
Reference:
JMIG 2541
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 30 January 2015 Revised Date:
2 April 2015
Accepted Date: 4 April 2015
Please cite this article as: Barrueto FF, Audlin KM, Gallicchio L, Miller C, MacDonald R, Alonsozana E, Johnston M, Helzlsouer KJ, The Sensitivity of Narrow Band Imaging Compared to White Light Imaging for the Detection of Endometriosis, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/ j.jmig.2015.04.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
1
The Sensitivity of Narrow Band Imaging Compared to White Light Imaging for the
2
Detection of Endometriosis
3
Fermin F. Barrueto1, M.D., Kevin M. Audlin1, M.D., Lisa Gallicchio1,2, Ph.D., Charles Miller3,4,
5
M.D., Ryan MacDonald1, Ph.D., Edgar Alonsozana1, M.D., Mary Johnston3, and Kathy J.
6
Helzlsouer1,5, M.D., M.H.S.
RI PT
4
SC
7
Affiliations
9
1
Mercy Medical Center, Baltimore, MD
10
2
Department of Epidemiology and Public Health, University of Maryland School of Medicine,
11
Baltimore, MD
12
3
Advocate Lutheran General Hospital Park Ridge IL
13
4
Department of Obstetrics & Gynecology, University of Illinois at Chicago, Chicago, IL
14
5
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health,
15
Baltimore, MD
TE D
M AN U
8
EP
16
Corresponding Author
18
Kathy J. Helzlsouer, M.D., M.H.S. The Prevention and Research Center Weinberg Women’s
19
Center for Health and Medicine, Mercy Medical Center, 301 St. Paul Place Baltimore, MD
20
21202
21
Phone: 410-951-7950; Fax: 410-951-7931; Email [email protected]
22
AC C
17
ACCEPTED MANUSCRIPT
Financial support and conflicts of interest statement: The study was funded by a research grant
24
provided by Olympus America, Inc. to Mercy Medical Center and Charles Miller, MDSC.
25
Additionally, Dr. Audlin reports personal fees from Gynecare and Olympus America, Inc outside
26
the submitted work. Dr. Barrueto reports personal fees in the form of honoraria for educational
27
programs from Olympus America, Inc. outside the submitted work.
AC C
EP
TE D
M AN U
SC
RI PT
23
ACCEPTED MANUSCRIPT
Abstract
29
STUDY OBJECTIVE: The primary objective of the study was to evaluate the ability of narrow
30
band imaging (NBI) in conjunction with standard white light imaging to improve the detection
31
and diagnosis of endometriosis during laparoscopic evaluation compared to white light imaging
32
alone. Sensitivity of NBI in detecting endometriosis was assessed and compared to white light
33
imaging.
34
DESIGN: A randomized controlled trial.
35
CLASSIFICATION OF STUDY DESIGN: LEVEL I: Evidence obtained from a properly
36
designed, randomized, controlled trial
37
SETTING: The trial was conducted in two medical centers.
38
PATIENTS:
39
endometriosis and/or infertility were recruited. Of these, 150 were evaluable for the primary aim
40
to determine sensitivity of NBI compared to white light imaging for the detection of
41
endometriotic lesions.
42
INTERVENTIONS: Patients were randomized in a 3:1 ratio to receive white light imaging
43
followed by NBI or white light imaging only. The pelvis was systematically visualized with
44
each assigned imaging modality; lesions were recorded under each visualization and then
45
resected. All patients had white light imaging on the first visualization followed by either a
46
second white light examination (control arm) or NBI examination (intervention arm.)
47
MEASUREMENT: Pathology of resected lesions was the gold standard for evaluating
48
sensitivity and was conducted at each institution. The method of detection of the lesion (white
49
light or NBI) was masked. Central pathology review was conducted for a randomly selected
50
10% sample of specimens and for those lesions visualized under only one imaging modality
M AN U
SC
RI PT
28
AC C
EP
TE D
A total of 167 women undergoing laparoscopic evaluation for suspected
ACCEPTED MANUSCRIPT
among patients assigned to the intervention arm. The sensitivity was assessed for each modality
52
(white light and NBI) and compared using a McNemar’s test.
53
MAIN RESULTS: Among the group randomized to receive both white light and NBI, four
54
patients had lesions detected with NBI but no lesions detected with white light. Among the 255
55
lesions confirmed as endometriosis by pathologic review, all were detected by NBI for a
56
sensitivity of 100%; 79% were detected by white light imaging (p
S1553-4650(15)00289-7
DOI:
10.1016/j.jmig.2015.04.005
Reference:
JMIG 2541
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 30 January 2015 Revised Date:
2 April 2015
Accepted Date: 4 April 2015
Please cite this article as: Barrueto FF, Audlin KM, Gallicchio L, Miller C, MacDonald R, Alonsozana E, Johnston M, Helzlsouer KJ, The Sensitivity of Narrow Band Imaging Compared to White Light Imaging for the Detection of Endometriosis, The Journal of Minimally Invasive Gynecology (2015), doi: 10.1016/ j.jmig.2015.04.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT
1
The Sensitivity of Narrow Band Imaging Compared to White Light Imaging for the
2
Detection of Endometriosis
3
Fermin F. Barrueto1, M.D., Kevin M. Audlin1, M.D., Lisa Gallicchio1,2, Ph.D., Charles Miller3,4,
5
M.D., Ryan MacDonald1, Ph.D., Edgar Alonsozana1, M.D., Mary Johnston3, and Kathy J.
6
Helzlsouer1,5, M.D., M.H.S.
RI PT
4
SC
7
Affiliations
9
1
Mercy Medical Center, Baltimore, MD
10
2
Department of Epidemiology and Public Health, University of Maryland School of Medicine,
11
Baltimore, MD
12
3
Advocate Lutheran General Hospital Park Ridge IL
13
4
Department of Obstetrics & Gynecology, University of Illinois at Chicago, Chicago, IL
14
5
Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health,
15
Baltimore, MD
TE D
M AN U
8
EP
16
Corresponding Author
18
Kathy J. Helzlsouer, M.D., M.H.S. The Prevention and Research Center Weinberg Women’s
19
Center for Health and Medicine, Mercy Medical Center, 301 St. Paul Place Baltimore, MD
20
21202
21
Phone: 410-951-7950; Fax: 410-951-7931; Email [email protected]
22
AC C
17
ACCEPTED MANUSCRIPT
Financial support and conflicts of interest statement: The study was funded by a research grant
24
provided by Olympus America, Inc. to Mercy Medical Center and Charles Miller, MDSC.
25
Additionally, Dr. Audlin reports personal fees from Gynecare and Olympus America, Inc outside
26
the submitted work. Dr. Barrueto reports personal fees in the form of honoraria for educational
27
programs from Olympus America, Inc. outside the submitted work.
AC C
EP
TE D
M AN U
SC
RI PT
23
ACCEPTED MANUSCRIPT
Abstract
29
STUDY OBJECTIVE: The primary objective of the study was to evaluate the ability of narrow
30
band imaging (NBI) in conjunction with standard white light imaging to improve the detection
31
and diagnosis of endometriosis during laparoscopic evaluation compared to white light imaging
32
alone. Sensitivity of NBI in detecting endometriosis was assessed and compared to white light
33
imaging.
34
DESIGN: A randomized controlled trial.
35
CLASSIFICATION OF STUDY DESIGN: LEVEL I: Evidence obtained from a properly
36
designed, randomized, controlled trial
37
SETTING: The trial was conducted in two medical centers.
38
PATIENTS:
39
endometriosis and/or infertility were recruited. Of these, 150 were evaluable for the primary aim
40
to determine sensitivity of NBI compared to white light imaging for the detection of
41
endometriotic lesions.
42
INTERVENTIONS: Patients were randomized in a 3:1 ratio to receive white light imaging
43
followed by NBI or white light imaging only. The pelvis was systematically visualized with
44
each assigned imaging modality; lesions were recorded under each visualization and then
45
resected. All patients had white light imaging on the first visualization followed by either a
46
second white light examination (control arm) or NBI examination (intervention arm.)
47
MEASUREMENT: Pathology of resected lesions was the gold standard for evaluating
48
sensitivity and was conducted at each institution. The method of detection of the lesion (white
49
light or NBI) was masked. Central pathology review was conducted for a randomly selected
50
10% sample of specimens and for those lesions visualized under only one imaging modality
M AN U
SC
RI PT
28
AC C
EP
TE D
A total of 167 women undergoing laparoscopic evaluation for suspected
ACCEPTED MANUSCRIPT
among patients assigned to the intervention arm. The sensitivity was assessed for each modality
52
(white light and NBI) and compared using a McNemar’s test.
53
MAIN RESULTS: Among the group randomized to receive both white light and NBI, four
54
patients had lesions detected with NBI but no lesions detected with white light. Among the 255
55
lesions confirmed as endometriosis by pathologic review, all were detected by NBI for a
56
sensitivity of 100%; 79% were detected by white light imaging (p
