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Hepatic Steatosis After Cholecystectomy (HSAC)

This study is ongoing, but not recruiting participants.

Sponsor:
Sangchul Yun
Information provided by (Responsible Party):
Sangchul Yun, Soonchunhyang University Hospital

ClinicalTrials.gov Identifier:
NCT02493153
First received: July 6, 2015
Last updated: November 20, 2015
Last verified: November 2015
History of Changes

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Purpose

The investigators are very pleased to register the study entitled "A prospective study for the effect of
cholecystectomy to the liver in consideration of hepatic steatosis 3months after cholecystectomy with
Ultrasound".
This study deals with prospective ultrasound study about hepatic steatosis development 3 months
after cholecystectomy. This study was approved by the Institutional Review Board of the local
institute. From Oct, 2013 to Jul, 2014, assessment of liver changes after cholecystectomy was carried
out in 82 patients with gallbladder disease. In conclusion, the investigators thought that
cholecystectomy might be considered as a risk factor for hepatic steatosis.

Condition Intervention

Hepatic Steatosis Procedure: Laparoscopic Cholecystectomy

Study Type: Observational

Study Design: Observational Model: Cohort
Time Perspective: Prospective

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Official Title: A Prospective Study for the Effect of Cholecystectomy to the Liver in Consideration
of Hepatic Steatosis 3months After Cholecystectomy With Ultrasound

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Further study details as provided by Sangchul Yun, Soonchunhyang University Hospital:

Primary Outcome Measures:

Ultrasound finding of hepatic steatosis [ Time Frame: 3 months ]

Biospecimen Retention: Samples Without DNA

Liver biopsy was performed during cholecystectomy using liver wedge resection in 10 patients who
had provided informed consent preoperatively. All specimens were reviewed by two pathologists with
single blinded method. Sections were stained with hematoxylin and eosin (H&E) and examined at
X40 magnification. Steatosis was divided into four stages using the Brunt criteria.

Estimated Enrollment: 82
Study Start Date: October 2013
Estimated Study Completion Date: July 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome
measure)

Intervention Details:
Procedure: Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy
Detailed Description:

All subjects underwent a complete medical history and physical examination. Physical examination
included measurements of height and weight. Subjects with a body mass index (BMI) 30 kg/m2
were considered obese. Laboratory tests included white blood cell (WBC) count, serum albumin,
alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total
bilirubin, amylase, lipase, total cholesterol, triglycerides (TG), high density lipoprotein cholesterol
(HDL-C), low density lipoprotein cholesterol (LDL-C), and high-sensitivity C-reactive protein (hsCRP).
In order to analyze the presence and severity of hepatic steatosis, hepatic steatosis index (HSI), US
and liver biopsy was used. The hepatic steatosis index (HSI) was calculated as 8 ALT/AST + BMI
+2 (if diabetes) +2 (if female gender). All patients underwent US at the time of operation and 3
months postoperatively. All US procedures were performed by one board-certified radiologist who did
not have information about the patients. Procedures were done using an iU22 apparatus (Philips
Ultrasound, Bothell, WA, USA) or an EUB-7500 apparatus (Hitachi, Tokyo, Japan) equipped with a 5
MHz convex transducer. For evaluation of fatty liver, the severity of liver echogenicity was
categorized. Normal echogenicity was a mild and slightly diffuse increase in hepatic echogenicity with
normal visualization of diaphragm and intrahepatic vessels. Moderate echogenicity was a moderately
diffuse increase in hepatic echogenicity with slightly impaired visualization of diaphragm and
intrahepatic vessels. Severe echogenicity was a marked increase in hepatic echogenicity with poor or

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nonvisualization of the intrahepatic vessel borders, diaphragm, and posterior segment of the right
hepatic lobe.
Each US image was reread by the same radiologist who was blinded to the initial reading 1 month
after the initial assessment to assess intraobserver variability. Liver biopsy was performed during
cholecystectomy using liver wedge resection in 10 patients who had provided informed consent
preoperatively. All specimens were reviewed by two pathologists with single blinded method. Sections
were stained with hematoxylin and eosin (H&E) and examined at X40 magnification. Steatosis was
divided into four stages using the Brunt criteria.

Eligibility

Ages Eligible for Study: 18 Years to 90 Years (Adult, Senior)

Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample

Study Population
From Oct, 2013 to Jul, 2014, a cohort of 82 consecutive patients with cholecystectomy was
prospectively collected and followed-up.

Criteria

Inclusion Criteria:
From Oct, 2013 to Jul, 2014, patients with a presumptive diagnosis of cholelithiasis and
gallbladder polyps who was cholecystectomized
Exclusion Criteria:
inflammatory diseases; anemia; hemochromatosis; Wilson disease; autoimmune hepa-titis;
primary biliary cirrhosis; sclerosing cholangitis; biliary obstruction; alpha-1 antitrypsin deficiency;
ischemic cardiac or cerebrovascular disease; impaired renal function; malignancies; use of
estrogens, amiodarone, steroids, tamoxifen, or lipid-lowering agents; viral hepatitis (positive
serum hepatitis B surface antigen and positive serum hepatitis C antibody); iron overload
(transferrin saturation 50%); and pregnancy.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family
members or friends about deciding to join a study. To learn more about this study, you or your doctor
may contact the study research staff using the Contacts provided below. For general information, see
Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02493153

Sponsors and Collaborators

Sangchul Yun

Investigators

Principal Investigator: Dongho Choi Hanyang University College of Medicine

More Information

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Publications:

Ruhl CE, Everhart JE. Relationship of non-alcoholic fatty liver disease with cholecystectomy in the
US population. Am J Gastroenterol. 2013 Jun;108(6):952-8. doi: 10.1038/ajg.2013.70. Epub 2013
Apr 2.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yun S, Choi D, Lee KG, Kim HJ, Kang BK, Kim H, Paik SS. Cholecystectomy Causes Ultrasound
Evidence of Increased Hepatic Steatosis. World J Surg. 2016 Jun;40(6):1412-21. doi:
10.1007/s00268-015-3396-7.

Responsible Party: Sangchul Yun, M.D., Ph.D, Soonchunhyang University Hospital

ClinicalTrials.gov Identifier: NCT02493153 History of Changes
Other Study ID Numbers: HY-2013-N
Study First Received: July 6, 2015
Last Updated: November 20, 2015

Additional relevant MeSH terms:

Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 12, 2017

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