Hepatic Steatosis After Cholecystectomy

NCT02493153 | Unknown

• 1 other identifier: HY-2013-N
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatic Steatosis

Outcome Measures

Primary Outcomes (1)

• Ultrasound finding of hepatic steatosis

  3 months

Interventions

Laparoscopic Cholecystectomy PROCEDURE

Laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• From Oct, 2013 to Jul, 2014, patients with a presumptive diagnosis of cholelithiasis and gallbladder polyps who was cholecystectomized

You may not qualify if:

• 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; malignan¬cies; 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.

Sponsors & Collaborators

• Sangchul Yun: lead

Related Publications (2)

• 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.

  PMID: 23545713 RESULT

• 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.

  PMID: 26796885 DERIVED

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.

MeSH Terms

Conditions

Fatty Liver

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Dongho Choi

  Hanyang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 9, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 23, 2015

Record last verified: 2015-11