Effectiveness of bariatric surgery for patients with liver disease
Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
Beijing Friendship Hospital · NCT04366999
This study is testing how well different types of weight loss surgery can help obese people with liver disease feel better and improve their liver health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04366999 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of bariatric surgery in obese patients diagnosed with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) with fibrosis. It aims to compare the outcomes of different surgical techniques, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass. The study began in 2020 with a cohort of patients and plans to expand with a secondary cohort in 2024. The focus is on assessing histological remission of liver disease post-surgery.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 16 to 65 with a diagnosis of NAFLD or NASH with fibrosis who are scheduled for bariatric surgery.
Not a fit: Patients who have previously undergone any type of bariatric surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective surgical options for improving liver health in obese patients with NAFLD/NASH.
How similar studies have performed: Other studies have shown promising results regarding the effectiveness of bariatric surgery for liver conditions, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \[For Base-NAFLD\] 1. Age between 16 and 65 years (all sexes). 2. 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. 3. 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. \[For Base-NASH\] 1. Age between 16 and 65 years (all sexes). 2. 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. 3. 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 Criteria: * 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Zhongtao Zhang, M.D.;Ph.D. — Beijing Friendship Hospital
- Study coordinator: Zhongtao Zhang, M.D.;Ph.D.
- Email: zhangzht@ccmu.edu.cn
- Phone: +86-13801060364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis, Bariatric surgery, NASH, Fibrosis, Obesity