Status:
RECRUITING
Effectiveness of Bariatric Surgery for NAFLD/NASH
Lead Sponsor:
Beijing Friendship Hospital
Collaborating Sponsors:
Beijing Tiantan Hospital
Beijing Hospital (only for Base-NAFLD)
Conditions:
Bariatric Surgery Candidate
NAFLD
Eligibility:
All Genders
16-65 years
Brief Summary
This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery. This study aims to explore the the effectiveness of bariatric surgery for NAFLD/NASH w...
Eligibility Criteria
Inclusion
- \[For Base-NAFLD\]
- Age between 16 and 65 years (all sexes).
- Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.
- Diagnosed with hepatic steatosis preoperatively by radiologic (including ultrasonography, magnetic resonance imaging \[MRI\]-derived proton density fat fraction \[PDFF\]) or pathologic(intraoperative hepatic pathology) examinations.
- \[For Base-NASH\]
- Age between 16 and 65 years (all sexes).
- Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.
- Histologically confirmed NASH with fibrosis:
- NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1
Exclusion
- any patient who had previously been submitted to any type of bariatric surgery;
- history of excessive drinking: in the past 12 months, the male equivalent of alcohol consumption more than 30g/d, and the female more than 20g/d;
- history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.；
- history of specific diseases: Gene type 3 hepatitis C virus (HCV) infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of beta lipoproteinemia, congenital lipid atrophy, celiac disease which causing fatty liver, etc.;
- previous major gastrointestinal surgery；
- diagnosed or suspected malignancy；
- poorly controlled significant medical or psychiatric disorders；
- disorders such as a medical history of major pathology;
- can not be able to understand and willing to participate in this registry with signature.
Key Trial Info
Start Date :
April 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04366999
Start Date
April 21 2020
End Date
December 31 2026
Last Update
May 14 2024
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050