GallstonesNCT02469935
Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
An observational study of Gallstones, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the detection of gallstones. Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound examination, were examined with a right upper quadrant ultrasound scan by a radiologist as well as surgeon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstones
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the radiology department for an abdominal ultrasound.
Who may be able to join
- Patients referred to the radiology department for an abdominal ultrasound
- Age > 18 years
Who cannot join
- Inability to communicate with the examiner
- Referral for intervention
- Metastasis screening
- Referrals concerning contrast enhanced examinations
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet Södersjukhuset (South General Hospital)
Stockholm, Stockholm County, S-11883
About this study
Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the detection of gallstones.
Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound examination, were examined with a right upper quadrant ultrasound scan by a radiologist as well as surgeon. The surgeons had undergone a four-week long education in ultrasound before participating in the study. Ultrasound findings of the surgeon were compared to those of the radiologist, using radiologist-performed ultrasound as reference standard.
Read the detailed description
Enrolment of patients:
Three hundred patients, with an acute or elective referral to the radiology department at Stockholm South General Hospital, Sweden, for any diagnostic abdominal US examination, including both patients admitted to in-hospital care and out-patients, were prospectively enrolled between October 2011 and November 2012. Eligible patients were identified in the radiology department by a study surgeon and informed consent was obtained. Six US educated surgeons participated in the enrolment of patients. Exclusion criteria were age <18 years or inability to communicate with the examiner. Referrals concerning metastases of the liver or contrast-enhanced examinations were considered not suitable for the study and were also excluded. The surgeons examined patients consecutively if time was available, but mostly they didn't have time to examine every patient referred per day, hence a certain prioritisation between referrals was done.
Data collection:
Enrolled patients received one US examination by the study surgeon as well as the standard US examination by the on-duty radiologist. In a majority of cases the two examinations were performed consecutively and the time interval between the surgeon-performed US and radiologist-performed US never exceeded 24 hours. The surgeon's examination took place either before or right after the radiologist's examination. The examining surgeon and radiologist were blinded to each other's findings. The surgeon's US examination followed a standardised protocol, which included a full abdominal scan, regardless of the nature of the referral. The presence of gallstones was marked as a 'yes' (positive finding, regardless of number or size) or 'no' (negative finding) by the surgeon. In cases where a full abdominal scan could not be performed, due to urgent patient management, a focused examination based on the referral as well as a right upper quadrant (RUQ) scan was advised. The on-duty radiologist performed a standard care US focusing on the individual referrals. The radiologist's statement was collected from the patient's medical record and transferred to the study protocol by a separate radiologist, who was also blinded to the surgeon's examination. Among the radiologists the major part of the scans was done by US specialised radiologists with several years of training (56% US specialists, 73% specialists in radiology).
The surgeons used a portable US machine of the model LOGIQ e with a convex (1.6-4.6 MHz) or linear (5-13 MHz) transducer, GE Healthcare, WuXi, China. All scans were saved on a separate hard drive, which was kept together with the study protocol. The radiologists used Philips iU22 with a convex C5-1 or a linear L12-5 transducer.
US training of surgeons participating in the study:
Six study surgeons, five in the final years of their specialist training and one specialist in surgery, with limited or no previous US training, attended a one-week course, comprising US physics, technique, anatomy and hands-on training, led by specialists in US. After attending the course the surgeons received three weeks of training in the radiology department under the guidance of an US specialist. The surgeons were expected to perform a minimum of 50 supervised scans, which was obtained in all cases but one. The training focused on detecting gallbladder stones, widened bile ducts, thickened wall of the gallbladder, lesions in the liver parenchyma, hydronephrosis, abdominal aortic aneurysms, free abdominal fluid and appendicitis. After the training was completed, each surgeon spent a minimum of two weeks enrolling and scanning patients during office hours in the hospital's radiology department.
Ethics:
The patients received oral and written information from the study surgeon and were included after informed consent. The study was approved by the Ethical Review Board, at Karolinska Institutet, Stockholm, Sweden.
- Conditions
- Gallstones
- Being tested
- ultrasound
- Keywords
- Validation, Surgeon-performed ultrasound, Gallstones
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or surgery
surgeon-performed ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of surgeon-performed ultrasound
Compared to radiologist-performed ultrasound
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for GallstonesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Gustafsson, Karolinska Institutet
- Investigators
- Anders Sonden, MD. PhD, Principal investigator, Karolinska Institutet Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469935
- Sponsor's protocol ID
- 2011/1025-31/1
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Powers RD, Guertler AT. Abdominal pain in the ED: stability and change over 20 years. Am J Emerg Med. 1995 May;13(3):301-3. doi: 10.1016/0735-6757(95)90204-X.
PubMed 7755822Cooperberg PL, Burhenne HJ. Real-time ultrasonography. Diagnostic technique of choice in calculous gallbladder disease. N Engl J Med. 1980 Jun 5;302(23):1277-9. doi: 10.1056/NEJM198006053022303.
PubMed 7366693Kell MR, Aherne NJ, Coffey C, Power CP, Kirwan WO, Redmond HP. Emergency surgeon-performed hepatobiliary ultrasonography. Br J Surg. 2002 Nov;89(11):1402-4. doi: 10.1046/j.1365-2168.2002.02297.x.
PubMed 12390381Rozycki GS. Surgeon-performed ultrasound: its use in clinical practice. Ann Surg. 1998 Jul;228(1):16-28. doi: 10.1097/00000658-199807000-00004.
PubMed 9671062Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
PubMed 21345104Allemann F, Cassina P, Rothlin M, Largiader F. Ultrasound scans done by surgeons for patients with acute abdominal pain: a prospective study. Eur J Surg. 1999 Oct;165(10):966-70. doi: 10.1080/110241599750008099.
PubMed 10574106Lindelius A, Torngren S, Pettersson H, Adami J. Role of surgeon-performed ultrasound on further management of patients with acute abdominal pain: a randomised controlled clinical trial. Emerg Med J. 2009 Aug;26(8):561-6. doi: 10.1136/emj.2008.062067.
PubMed 19625549Fang R, Pilcher JA, Putnam AT, Smith T, Smith DL. Accuracy of surgeon-performed gallbladder ultrasound. Am J Surg. 1999 Dec;178(6):475-9. doi: 10.1016/s0002-9610(99)00225-1.
PubMed 10670856Ahmad S, Zafar A, Ahmad M, Ghafoor A, Malik E, Ali A, Qazi UA. Accuracy of surgeon-performed abdominal utrasound for gallstones. J Ayub Med Coll Abbottabad. 2005 Jan-Mar;17(1):70-1.
PubMed 15929534Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81.
PubMed 7979854Carroll PJ, Gibson D, El-Faedy O, Dunne C, Coffey C, Hannigan A, Walsh SR. Surgeon-performed ultrasound at the bedside for the detection of appendicitis and gallstones: systematic review and meta-analysis. Am J Surg. 2013 Jan;205(1):102-8. doi: 10.1016/j.amjsurg.2012.02.017. Epub 2012 Jun 29.
PubMed 22748292Lindelius A, Torngren S, Sonden A, Pettersson H, Adami J. Impact of surgeon-performed ultrasound on diagnosis of abdominal pain. Emerg Med J. 2008 Aug;25(8):486-91. doi: 10.1136/emj.2007.052142.
PubMed 18660395Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998 Apr 30;17(8):857-72. doi: 10.1002/(sici)1097-0258(19980430)17:83.0.co;2-e.
PubMed 9595616Irkorucu O, Reyhan E, Erdem H, Cetinkunar S, Deger KC, Yilmaz C. Accuracy of surgeon-performed gallbladder ultrasound in identification of acute cholecystitis. J Invest Surg. 2013 Apr;26(2):85-8. doi: 10.3109/08941939.2012.697977. Epub 2012 Dec 28.
PubMed 23273179Scruggs W, Fox JC, Potts B, Zlidenny A, McDonough J, Anderson CL, Larson J, Barajas G, Langdorf MI. Accuracy of ED Bedside Ultrasound for Identification of gallstones: retrospective analysis of 575 studies. West J Emerg Med. 2008 Jan;9(1):1-5.
PubMed 19561694
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
- ClinicalTrials.gov ID
- NCT02469935
- Acronym / sponsor ID
- 2011/1025-31/1
- Conditions
- Gallstones
- Keywords
- Validation, Surgeon-performed ultrasound, Gallstones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims: To prospectively investigate the accuracy of surgeon-performed ultrasound for the detection of gallstones.
Methods: 179 adult patients, with an acute or elective referral for an abdominal ultrasound examination, were examined with a right upper quadrant ultrasound scan by a radiologist as well as surgeon. The surgeons had undergone a four-week long education in ultrasound before participating in the study. Ultrasound findings of the surgeon were compared to those of the radiologist, using radiologist-performed ultrasound as reference standard.
Detailed description
Enrolment of patients:
Three hundred patients, with an acute or elective referral to the radiology department at Stockholm South General Hospital, Sweden, for any diagnostic abdominal US examination, including both patients admitted to in-hospital care and out-patients, were prospectively enrolled between October 2011 and November 2012. Eligible patients were identified in the radiology department by a study surgeon and informed consent was obtained. Six US educated surgeons participated in the enrolment of patients. Exclusion criteria were age <18 years or inability to communicate with the examiner. Referrals concerning metastases of the liver or contrast-enhanced examinations were considered not suitable for the study and were also excluded. The surgeons examined patients consecutively if time was available, but mostly they didn't have time to examine every patient referred per day, hence a certain prioritisation between referrals was done.
Data collection:
Enrolled patients received one US examination by the study surgeon as well as the standard US examination by the on-duty radiologist. In a majority of cases the two examinations were performed consecutively and the time interval between the surgeon-performed US and radiologist-performed US never exceeded 24 hours. The surgeon's examination took place either before or right after the radiologist's examination. The examining surgeon and radiologist were blinded to each other's findings. The surgeon's US examination followed a standardised protocol, which included a full abdominal scan, regardless of the nature of the referral. The presence of gallstones was marked as a 'yes' (positive finding, regardless of number or size) or 'no' (negative finding) by the surgeon. In cases where a full abdominal scan could not be performed, due to urgent patient management, a focused examination based on the referral as well as a right upper quadrant (RUQ) scan was advised. The on-duty radiologist performed a standard care US focusing on the individual referrals. The radiologist's statement was collected from the patient's medical record and transferred to the study protocol by a separate radiologist, who was also blinded to the surgeon's examination. Among the radiologists the major part of the scans was done by US specialised radiologists with several years of training (56% US specialists, 73% specialists in radiology).
The surgeons used a portable US machine of the model LOGIQ e with a convex (1.6-4.6 MHz) or linear (5-13 MHz) transducer, GE Healthcare, WuXi, China. All scans were saved on a separate hard drive, which was kept together with the study protocol. The radiologists used Philips iU22 with a convex C5-1 or a linear L12-5 transducer.
US training of surgeons participating in the study:
Six study surgeons, five in the final years of their specialist training and one specialist in surgery, with limited or no previous US training, attended a one-week course, comprising US physics, technique, anatomy and hands-on training, led by specialists in US. After attending the course the surgeons received three weeks of training in the radiology department under the guidance of an US specialist. The surgeons were expected to perform a minimum of 50 supervised scans, which was obtained in all cases but one. The training focused on detecting gallbladder stones, widened bile ducts, thickened wall of the gallbladder, lesions in the liver parenchyma, hydronephrosis, abdominal aortic aneurysms, free abdominal fluid and appendicitis. After the training was completed, each surgeon spent a minimum of two weeks enrolling and scanning patients during office hours in the hospital's radiology department.
Ethics:
The patients received oral and written information from the study surgeon and were included after informed consent. The study was approved by the Ethical Review Board, at Karolinska Institutet, Stockholm, Sweden.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the radiology department for an abdominal ultrasound.
Key inclusion criteria (2 listed)
- Patients referred to the radiology department for an abdominal ultrasound
- Age > 18 years
Key exclusion criteria (4 listed)
- Inability to communicate with the examiner
- Referral for intervention
- Metastasis screening
- Referrals concerning contrast enhanced examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundsurgeon-performed ultrasound | Procedure or surgery | – |
Primary outcome
Accuracy of surgeon-performed ultrasound
Time frame: 13 months
Compared to radiologist-performed ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Results publication: PubMed 7755822Powers RD, Guertler AT. Abdominal pain in the ED: stability and change over 20 years. Am J Emerg Med. 1995 May;13(3):301-3. doi: 10.1016/0735-6757(95)90204-X.
- Results publication: PubMed 7366693Cooperberg PL, Burhenne HJ. Real-time ultrasonography. Diagnostic technique of choice in calculous gallbladder disease. N Engl J Med. 1980 Jun 5;302(23):1277-9. doi: 10.1056/NEJM198006053022303.
- Results publication: PubMed 12390381Kell MR, Aherne NJ, Coffey C, Power CP, Kirwan WO, Redmond HP. Emergency surgeon-performed hepatobiliary ultrasonography. Br J Surg. 2002 Nov;89(11):1402-4. doi: 10.1046/j.1365-2168.2002.02297.x.
- Results publication: PubMed 9671062Rozycki GS. Surgeon-performed ultrasound: its use in clinical practice. Ann Surg. 1998 Jul;228(1):16-28. doi: 10.1097/00000658-199807000-00004.
- Results publication: PubMed 21345104Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
- Results publication: PubMed 10574106Allemann F, Cassina P, Rothlin M, Largiader F. Ultrasound scans done by surgeons for patients with acute abdominal pain: a prospective study. Eur J Surg. 1999 Oct;165(10):966-70. doi: 10.1080/110241599750008099.
- Results publication: PubMed 19625549Lindelius A, Torngren S, Pettersson H, Adami J. Role of surgeon-performed ultrasound on further management of patients with acute abdominal pain: a randomised controlled clinical trial. Emerg Med J. 2009 Aug;26(8):561-6. doi: 10.1136/emj.2008.062067.
- Results publication: PubMed 10670856Fang R, Pilcher JA, Putnam AT, Smith T, Smith DL. Accuracy of surgeon-performed gallbladder ultrasound. Am J Surg. 1999 Dec;178(6):475-9. doi: 10.1016/s0002-9610(99)00225-1.
- Results publication: PubMed 15929534Ahmad S, Zafar A, Ahmad M, Ghafoor A, Malik E, Ali A, Qazi UA. Accuracy of surgeon-performed abdominal utrasound for gallstones. J Ayub Med Coll Abbottabad. 2005 Jan-Mar;17(1):70-1.
- Results publication: PubMed 7979854Shea JA, Berlin JA, Escarce JJ, Clarke JR, Kinosian BP, Cabana MD, Tsai WW, Horangic N, Malet PF, Schwartz JS, et al. Revised estimates of diagnostic test sensitivity and specificity in suspected biliary tract disease. Arch Intern Med. 1994 Nov 28;154(22):2573-81.
- Results publication: PubMed 22748292Carroll PJ, Gibson D, El-Faedy O, Dunne C, Coffey C, Hannigan A, Walsh SR. Surgeon-performed ultrasound at the bedside for the detection of appendicitis and gallstones: systematic review and meta-analysis. Am J Surg. 2013 Jan;205(1):102-8. doi: 10.1016/j.amjsurg.2012.02.017. Epub 2012 Jun 29.
- Results publication: PubMed 18660395Lindelius A, Torngren S, Sonden A, Pettersson H, Adami J. Impact of surgeon-performed ultrasound on diagnosis of abdominal pain. Emerg Med J. 2008 Aug;25(8):486-91. doi: 10.1136/emj.2007.052142.
- Statistical proceduresLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Sonden, MD. PhD principal investigator
Karolinska Institutet Södersjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstones, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of surgeon-performed ultrasound (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02469935, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.