Introduction
This manual is a revised version of the first edition [1,2,3] published jointly by the Japanese Society of Gastrointestinal Cancer Screening (JSGCS), the Japan Society of Ultrasonics in Medicine (JSUM), and Japan Society of Ningen Dock (JSND) in 2014.
Abdominal ultrasonography is distinct in that it is used to examine many organs, and it is applicable various kinds of disease including malignant neoplasm. Moreover, a procedure for describing examination findings had not been standardized. Therefore, its objective accuracy and efficacy as a screening modality could not be evaluated. In addition, there were no clear rules regarding examination procedures at any of the societies. Against this backdrop, the Guideline for Abdominal Ultrasound Cancer Screening [4, 5]—which was comprised of practice standards aimed at improving the quality of abdominal ultrasound cancer screening, and assessment criteria to allow for accurate assessment as a cancer screening modality—was published in 2011, led by the JSGCS Ultrasonic Screening Committee (former Ultrasonography Working Group). The Abdominal Ultrasound Screening Assessment Manual was subsequently created through a joint effort by the above-mentioned three societies by partially revising the Guideline and adding items and assessments. The aim was to improve the quality of and homogenize abdominal ultrasound screening, standardize examination results, and evaluate accuracy and efficacy through the widespread adoption of the Guideline by creating a manual shared by the three societies.
This revision had been planned to take place about 5 years after the original publication. The manual was revised by working groups at each of the three societies, with the additional participation of the Japanese Society of Sonographers (JSS), Japan Society of Health Evaluation and Promotion (JSHEP), and Japanese Association for Cancer Detection and Diagnosis (JACDD) as observer societies, based on current experience. The manual was created with the following structure: practice standards and specific ultrasound findings and categories, tables with ultrasound findings in Report Forms and assessments presented 1:1 and cautionary notes, and representative ultrasound images of the respective findings.
It is a well-known fact that the accuracy of ultrasonography differs depending on the status of the device, examiner, and examinee. In modern medicine, standards are required in terms of ergonomics and device conditions (including periodic inspections) to improve examination quality; the practice standards in this manual were revised based on the guidelines of each society as well as other sources. Although evidence is lacking in some areas and they are not required, we hope that institutions will refer to this manual as a rule of thumb for the current examination environment.
The biggest shortcoming of ultrasonography is a lack of objectivity, which it true of not only ultrasound images but also ultrasound findings and assessments. When we consider such factors as examinee/examiner transfers and diversification of secondary examination facilities, we predict a dramatic improvement in objectivity with the permeation of this manual, and we look forward to its widespread adoption going forward.
Practice standards
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(1)
Before beginning an examination
In terms of screening techniques performed primarily on people without symptoms, we have the "medical checkup," which is used to check and learn the level of an individual's health or check for risk of future disease, and "screening," the purpose of which is to check for the presence or absence of a specific disease. It should be noted that there are examinations where the two cannot be clearly distinguished based on the examination items [6]. Cancer screening, which is a typical screening, has two types: a population-based type carried out by municipalities and an opportunistic type carried out in other situations. In the case of population-based cancer screening, the Japanese government has proposed screening for five major cancers by modalities confirmed to lower the mortality rate. In addition to opportunistic cancer screening for hepatic cancer, renal cancer, and other cancers, this Abdominal Ultrasound Screening Assessment Manual also covers "screenings" to check for the presence or absence of disorders such as gallstones, as well as "medical checkups" to check for future disease risk such as hepatic steatosis and arteriosclerosis.
There are merits and demerits with any cancer screening, not just ultrasonography, but the merits must outweigh the demerits. Therefore, the examiner needs to understand the merits and demerits of cancer screening and improve the quality of the screening, and the examiner must obtain proper informed consent from the examinee. It is also important to understand that there are two distinct reasons for performing a thorough examination in response to an abnormal finding detected by screening: one is to make a definitive diagnosis of cancer and the other is to rule out suspected cancer.
Merits
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Early treatment based on early detection of cancer is possible.
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Psychological sense of relief when no abnormalities are found.
Demerits
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Possibility of false-negative tests (ultrasonography does not detect 100% of cancers).
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Possibility of false-positive tests (as a result, there is a possibility of examinee complications associated with unnecessary invasive procedures and examinations, and being subjected to psychological and economic strain).
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Possibility of overdiagnosis (detection of cancer that does not affect the vital prognosis).
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(2)
Target organs
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The target organs covered in this Manual are the liver, biliary tract, pancreas, spleen, kidneys, and abdominal aorta.
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Tell the examinee the target organs in advance, and explain that there may be some cases and sites where each organ may be difficult to observe.
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The adrenal gland and lower abdominal region (e.g., bladder, uterus, ovaries, and prostate) are not formally regarded as target organs, but any findings observed during the scanning process should be recorded. In addition, in cases where a target organ will be added with a voluntary contract with the client, clearly communicate the details of the examination to the examinee.
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(3)
Examination environment
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[1]
Diagnostic unit
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Use a convex probe with a frequency of 3.5-7.0 MHz.
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Add other probes such as a high-frequency probe (7.5 MHz or higher), linear probe, or microconvex probe as necessary according to the examinee's situation.
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Use of a unit capable of tissue harmonic imaging and color Doppler is recommended.
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Periodically perform appropriate maintenance/management of the diagnostic unit, and avoid using a unit beyond its service life (normally 7 years).
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[2]
Operators
A JSGCS gastrointestinal cancer screening general certified physician or gastrointestinal cancer screening certified physician (hepatobiliary system and pancreas), JSUM specialist or technician with an ultrasonographer qualification in the medical checkup domain or gastrointestinal domain certified by JSUM, Board Certified Physician of JSND, Health Evaluation and Promotion Specialist of JSHEP/JSND, Japan Radiological Society (JRS) radiology specialist, or Japanese Society of Laboratory Medicine (JSLM) clinical laboratory test specialist should be in charge of the examination.
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[3]
Advanced preparation
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Examinees with an examination scheduled for the morning should not eat solid foods or dairy products after 10 p.m. the night before.
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Examinees with an examination scheduled for the afternoon should not eat solid foods or dairy products within 6 h before the examination.
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Drinking liquids (e.g., cold/hot water) to prevent dehydration is allowed up to about 200 ml per time up to 2 h before the examination.
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In cases where a gastrointestinal tract examination will be performed the same day, perform ultrasonography first, with the exception of upper endoscopy using carbon dioxide [7].
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[4]
Peripheral facilities
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A proper examination environment is said to not only lessen examiner fatigue but also prevent misdiagnosis, making it an important factor.
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In addition to a private room to protect the examinee's privacy or equivalent examination room, there is an ergonomically recommended environment that encompasses everything including the heights of the examining table, chair, and monitor; therefore, one should aim to perform examinations under the correct environment (Refer to "Proposal from The Japan Society of Ultrasonics in Medicine for ultrasonographers to work safely, comfortably, and healthily: Equipment and work environment to prevent work-related musculoskeletal disorders and eye disorders" [8]).
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[5]
Precautions during epidemics
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The COVID-19 pandemic completely changed how screenings are performed. Examiners will need to familiarize themselves with ultrasonography-related precautions during epidemics in preparation for new infectious diseases in the future based on this experience.
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Ultrasonography has distinct examination procedures, sanitization procedures, and so forth that differ from those of other medical care.
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Take into account ultrasound screening methods during epidemics by referring to such sources as the Ultrasound Equipment and Safety Committee's "Recommendations and resources related to handling and safety of ultrasonic diagnostic equipment" [9,10,11] published on the JSUM website.
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[6]
Recording and scanning procedures
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There are a variety of image recording/storage methods depending on the institution, such as storage using a thermal printer, storage as DICOM data, and video storage on videotape/DVD. However, storage of DICOM data on electronic media is recommended from the viewpoint of secondary image interpretation and sending referral attachments to facilities for thorough examination.
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Perform measurements with the image adequately enlarged on the monitor, and denote measurements in millimeters, rounding off to the nearest integer. (However, evaluation of an entire organ can be denoted in centimeters.)
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For Category 3 or severer lesions and focal lesions, always record images from multiple directions, and also record and save the maximum diameter/scan site at the same time.
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With respect to the scanning procedure, carefully and thoroughly observing the entirety of each organ as a basic ultrasound scan, and properly evaluating not only focal lesions but also diffuse lesions throughout an entire organ, are fundamental.
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With respect to standards for sections to store during examinations, there is no nationwide uniform method. However, fundamental sections should be established to properly deal with situations, such as demonstration of the examination region, quality control, double interpretation, comparison of changes over time, referral to other institutions, education, and transfer of examiners/examinees.
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With respect to the position of the examinee, scans are almost always performed with the examinee in the supine position, but since the visualization capability of ultrasonography changes with a change of position, appropriate position changes (e.g., right and left half side-lying position, right and left lateral position, semi-sitting position, and sitting position) should be utilized in cases where observation in the supine position is insufficient.
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The time required for examinations will differ depending on the examination environment, but about 5-6 people without findings can be screened per hour (Ample time should be allocated as examination duration correlates with examination accuracy and the ability of the examiner.)
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Twenty-five recommended sections to record [12] and images by position change are presented here (Fig. 1, Fig. 2).
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[7]
Examination results/image interpretation/ultrasound image findings/assessments/post-examination management
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For examination results, record the results using the categories described later together with a record of the ultrasonography findings (Table 1-1).
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With respect to examinations performed by a technician, a JSGCS gastrointestinal cancer screening general certified physician or gastrointestinal cancer screening certified physician (hepatobiliary system and pancreatic), JSUM specialist, Board Certified Physician of JSND, Health Evaluation and Promotion Specialist of JSHEP/JSND, JRS radiology specialist, or JSLM clinical laboratory test specialist should make the final interpretation/diagnosis and complete a report.
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[1]
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(4)
Examination interval
Recommend annual screening even if there are no abnormal findings.
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(5)
Selection of institution for thorough examination
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Referral to an institution for thorough examination is an important factor for examinees; therefore, examinees should be instructed to visit and referred to an appropriate medical institution according to the screening results. In addition, it is important to maintain a line of communication with the receiving institution, so that requests can be made for feedback on the results of thorough examinations as it will serve as important information at annual screenings.
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When writing a referral, include not only the test results but also clearly state the details of the request for thorough examination, and also attach images from the entire examination (DICOM digital images are recommended).
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(6)
Quality control
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Controlling the screening process as a whole so that it is always properly performed is important in order for ultrasound screening to continue to be effective as a cancer screening modality going forward. In addition to internal quality control, it is recommended that the process also undergoes periodic outside evaluation.
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In addition to control of the examination environment including the diagnostic unit, quality control includes but is not limited to tabulation and management of examination results (e.g., percentage of examinees who required thorough examination, percentage of examinees who underwent thorough examination by category assessment, and cancer detection rate), ascertainment and tabulation of post-examination guidance (e.g., ascertainment and tracking of examinees who did and did not undergo thorough examination, screening recommendation, and ascertainment of screening sensitivity/specificity), and cooperation with and registration in nationwide tabulation.
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(7)
Education
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Continued education for physicians, clinical technologists, radiology technicians, nurses, and others involved in screening is important to update knowledge and improve skills.
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In addition to holding in-house review meetings to iron out differences of opinion and help improve diagnostic accuracy, an institution should create a system that allows team members to periodically participate in conferences, workshops, and training courses. Furthermore, providing support and cooperation aimed at team members acquiring JSGCS, JSUM, JSND, JSLM, and other qualifications is also important.
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- (8)
Categories and assessments
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(1)
Ultrasound imaging findings
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Operators should consider in detail to which ultrasound imaging finding item in the Manual the abnormal findings noted in observations of the liver, biliary tract, pancreas, spleen, kidneys, abdominal aorta, and other target organs correspond and select the applicable item.
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Although observation of organs other than the target organs is not essential, describe any findings that are noted.
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If an organ cannot be visualized at all, it should be assessed as "Unable to visualize." If part of an organ cannot be visualized, it should be assessed as "Poorly visualized" and regarded as equivalent to "Difficult to visualize" and "Inadequately visualized," and cases where the border is indistinct after partial resection, etc., should be included in this category; clearly describe poorly visualized sites and use findings from sites that could be visualized.
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(2)
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The cancer-related category, ultrasound findings (described in Report Form), and assessment are determined in accordance with the ultrasound imaging findings selected.
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Categories are criteria for cancer detection and also summaries of findings noted during ultrasonography.
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For each organ, the highest category should be recorded as the category for the organ. However, in cases where the highest category and highest assessment differ, both should be recorded (e.g., Category 2/Assessment D2, Category 3/Assessment C).
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For a lesion that can be compared with a past image, record comments on any chronological changes.
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If a lesion has findings corresponding to Assessment D2 or higher on ultrasound images but has been deemed to be benign as a result of thorough examination, the relevant category is indicated with an apostrophe [e.g., 0', 2', 3', 4'], and the assessment is C. (Note that the high-risk group is not included in this category.) (Fig. 3)
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(3)
Ultrasound findings (described in Report Form)
It consists of simplified terms for notification of ultrasound imaging findings to examinees. Ultrasound findings are described in the Report Form. Categories 4 and 5 are described as “Tumor” and Category 3 focal lesions as “Mass,” including suspected ones.
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(4)
Assessment (Table 3)
As a rule, the final assessment is determined by the physician in charge of assessment in accordance with the Manual based on abnormal findings on ultrasound images. However, the physician in charge of assessment can change the assessment as necessary based on test results other than ultrasonography and comparison with previous findings.
Notes
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P: Panic finding, Promptly report Category 5 lesions to the physician in charge of assessment.
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Promptly report it to the physician in charge of assessment in the case of findings indicative of transition to an emergency situation such as biliary stone.
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For Assessment C, the term "Follow-up observation needed" had been used until now, but the timing of follow-up observation was unclear; therefore, "Reexamination needed" will be used instead going forward to standardize the terminology at institutions, and the specific timing will be entered.
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The reexamination timing selected was 3/6/12 months, but it can be changed at the direction of the physician in charge of assessment.
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Reexaminations will be performed at a medical institution as necessary, but in the case of the 12-month reexamination, the examinee should be strongly recommended to undergo screening the following year.
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In the case of Category 2', 3', or 4' with Assessment C, ultrasonography at the annual screening 12 months later may be used as a substitute for reexamination.
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If "Reexamination needed" is selected, the examinee should be given specific instructions regarding the institution to visit for reexamination.
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If "Thorough examination needed" is selected, the examinee should be given specific instructions regarding the institution to visit for thorough examination and examination procedures, etc.
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When the examinee undergoes reexamination (e.g., during dietary therapy for hepatic steatosis, or main pancreatic duct dilatation/pancreatic cyst) either in-house or at another institution (every 3/6/12 months), the assessment should be C, not E.
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Assessment C or E may be selected if the examinee has undergone thorough examination at another medical institution and continues to be followed up by the institution. However, for an examinee in the group at high risk for cancer, Assessment D2 may be selected after hearing the details of examinations performed at the medical institution.
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A Category 3 lesion may be assessed as C if there are no chronological changes compared with at least the past 2 results.
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Assessment D2 may be selected as necessary if the diameter of the focal lesion or lumen definitely increases compared to the previous result.
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If organ atrophy is found, refer to the past medical history, history of present illness, or treatment history when making the assessment.
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In the case of total resection, partial resection, or detection of treatment scar, refer to the past medical history or history of present illness when making the assessment.
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Make use of color Doppler ultrasound as appropriate to aid assessment.
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Assessment D2 may be selected as necessary for a focal lesion in the liver if chronic hepatic disease is suspected based on clinical biochemistry data such as infection with HBV or HCV or presence of thrombocytopenia (<15,000/μL).
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Assessment D2 may be selected if a biliary tract enzyme abnormality is found in a case with a poorly visualized extrahepatic bile duct.
Data availability statement
The author guideline of JOMU does not require Data availability statement. Also, this article is guideline and there are no data generated by the research group.
References
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Acknowledgements
List of Contributors: Terminology and Diagnostic Criteria Committee of The Japan Society of Ultrasonics in Medicine. Subcommittee on Revision of the Manual for Abdominal Ultrasound in Cancer Screening and Health Checkups. Committee member Masayuki KITANO (Second Department of Internal Medicine, Wakayama Medical University); Yutaka CHIBA (Department of Home Care, Kikyogahara Hospital); Masahiko NAKATA (Department of Obstetrics and gynecology, Toho University Omori Medical Center); Takashi NISHIMURA (Department of Gastroenterology and Hepatology, Hyogo Medical University); Hiroshi MATSUO (Matsuo Clinic); Hideaki MORI (Department of Gastroenterology and Hepatology, Kyorin University School of Medicine); Noritaka WAKUI (Department of Gastroenterology and Hepatology, Toho University Omori Medical Center). Japanese Society of Sonographers Akira KUWAJIMA (PL Tokyo Health Control Center); Ryuzo SEKIGUCHI (Toho University Omori Medical Center). Japanese Association for Cancer Detection and Diagnosis Satoru IKEDA (Kurashiki Medical Check-up Center). Image Provider Yoshitomo Ishikawa, Kazuhiro Iwashita, Shinji Okaniwa, Masahiro Ogawa, Ayumi Oguri, Norikazu Obane, Mitsuko Kato, Masahiro Kaneko, Satoshi Kawabata, Kiyofumi Kawabata, Takako Kojima, Miho Saito, Hitomi Sasaki, Yoko Sugino, Asako Sugimoto, Seiichiro Suda, Ryosuke Taiji, Yu Tamura, Yuko Chiba, Mika Tojo, Ayaka Nakajima, Naomi Tanaka, Toru Nishikawa, Shigehiko Nishimura. Katsuyoshi Hayashi, Takeshi Hisa, Toshiko Hirai, Midori Hirayama, Megumi Honma, Nagaaki Marugami, Michie Miura, Masanori Miyashita, Yukiko Morimoto, Satoshi Yamauchi, Toshiki Yamamoto, Hiroka Yoshinaga, Satoshi Wakasugi, Noriko Watanabe, Yukinobu Watanabe.
Funding
This work was supported by the Ministry of Health, Labor and Welfare (MHLW) Sciences Research Grant (Comprehensive Research on Life-Style Related Diseases including Cardiovascular Diseases and Diabetes Mellitus, 20FA1021, PI: Dr. Takashi WADA).
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Members, etc., who created this manual were asked to declare the following conflicts of interest. With respect to companies/organizations from which the member himself or herself, a spouse, a first-degree or closer relative, an individual with whom he or she shares income/assets, or the director of an institution/division to which he or she belongs received some form of compensation: compensation (≥ 1 million yen), profit from stock (≥ 1 million yen, or ≥ 5%), patent royalty (≥ 1 million yen), lecture fee, etc. (≥ 500,000 yen), manuscript fee (≥ 500,000 yen), research expenses/grant (≥ 1 million yen), scholarship donation, etc. (≥ 1 million yen), endowed course provided by corporation, etc. (≥ 1 million yen), and provision of funds not directly related to research (≥ 50,000 yen). Masahiro OGAWA (compensation: GE Healthcare Japan, Canon Medical Systems, Dainippon Sumitomo Pharma), Shinji OKANIWA (compensation: GE Healthcare Japan, Canon Medical Systems), Masaki ADACHI (compensation: Medical Egg), Masayuki KITANO (lecture fee: Olympus, EA Pharma, Kaneka Medix, scholarship donation: AbbVie, Takeda Pharmaceutical), Masahiko NAKATA (scholarship donation: Hitachi Healthcare Business Unit), Takashi NISHIMURA(scholarship donation: Canon Medical Systems GE Healthcare Japan), Hiroshi MATSUO (lecture fee: Daiichi Sankyo).
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This article was originally published in the Journal of the Japanese Society for Gastrointestinal Cancer Screening, 2022; 60: 125–181, and is reprinted in English with permission of the Editorial Board of the Japanese Society for Gastrointestinal Cancer Screening.
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Okaniwa, S., Hirai, T., Ogawa, M. et al. Manual for abdominal ultrasound in cancer screening and health checkups, revised edition (2021). J Med Ultrasonics 50, 5–49 (2023). https://doi.org/10.1007/s10396-022-01272-w
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DOI: https://doi.org/10.1007/s10396-022-01272-w