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NCT04366999Recruiting

Effectiveness of Bariatric Surgery for NAFLD/NASH

Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study

Source: ClinicalTrials.gov · Last updated 14 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 with fribrosis, to explore the differences in the effectiveness among sleeve gastrostomy \[SG\], Roux-en-Y gastric bypass \[RYGB\], or one anastomosis gastric bypass \[OAGB\], and to explore the independent effectiveness of bariatric surgery in histological remission of NAFLD/NASH. The first stage of the cohort was started in 2020, named Base-NAFLD; In May 2024, based on Base-NAFLD, we plan to continue established a secondary cohort, named Base-NASH.

Status (registry)
Recruiting
Study type
Observational
Enrollment
320 (estimated)
First submitted
21 Apr 2020
Start date
21 Apr 2020
Primary completion date
31 Dec 2024
Lead sponsor
Beijing Friendship Hospital
NCT number
NCT04366999

What you commit to

  • Study type: Observational
  • Planned participants: 320
  • From 21 Apr 2020 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • any patient who had previously been submitted to any type of bariatric surgery;
  • previous major gastrointestinal surgery;

Other illness

  • 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.;
  • diagnosed or suspected malignancy;
  • poorly controlled significant medical or psychiatric disorders;
  • disorders such as a medical history of major pathology;

Other

  • can not be able to understand and willing to participate in this registry with signature.

Who the study is looking for

  • \[For Base-NAFLD\]
  • 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

Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Friendship Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.