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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ \[For Base-NAFLD\]

• 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

Locations
Other Locations
China
Beijing Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhongtao Zhang, M.D.;Ph.D.
zhangzht@ccmu.edu.cn
+86-13801060364
Backup
Mengyi Li, M.D.;Ph.D.
limengyi@ccmu.edu.cn
+86-15810993198
Time Frame
Start Date: 2020-04-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 320
Treatments
SG
In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure.
RYGB
In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure.
OAGB
In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure.
Sponsors
Collaborators: Capital Medical University, Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD), Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD), Beijing Hospital (only for Base-NAFLD), The First Hospital of Hebei Medical University, Bishan Hospital of Chongqiang Medical University, Beijing Chao Yang Hospital, The First Hospital of Kunming, Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD), Beijing Tiantan Hospital
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov