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Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study

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ClinicalTrials.gov Identifier: NCT02469935
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Camilla Gustafsson, Karolinska Institutet

Tracking Information
First Submitted Date June 3, 2015
First Posted Date June 12, 2015
Last Update Posted Date June 12, 2015
Study Start Date October 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2015)
Accuracy of surgeon-performed ultrasound [ Time Frame: 13 months ]
Compared to radiologist-performed ultrasound
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
Official Title Accuracy of Surgeon-performed Ultrasound in Detecting Gallstones - a Validation Study
Brief 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. 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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients referred to the radiology department for an abdominal ultrasound.
Condition Gallstones
Intervention Procedure: ultrasound
surgeon-performed ultrasound
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2015)
300
Original Actual Enrollment Same as current
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients referred to the radiology department for an abdominal ultrasound
  • Age > 18 years

Exclusion Criteria:

  • Inability to communicate with the examiner
  • Referral for intervention
  • Metastasis screening
  • Referrals concerning contrast enhanced examinations
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02469935
Other Study ID Numbers 2011/1025-31/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Camilla Gustafsson, Karolinska Institutet
Study Sponsor Karolinska Institutet
Collaborators Not Provided
Investigators
Principal Investigator: Anders Sonden, MD. PhD Karolinska Institutet Södersjukhuset
PRS Account Karolinska Institutet
Verification Date June 2015