Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
320 participants
OBSERVATIONAL
2020-04-21
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SG
In this group, the bariatric procedure is sleeve gastrectomy (SG), all operations follow the same standard operating procedure.
SG
SG involved a vertical gastric resection beginning 4-6 cm from the pylorus and ending 1-2 cm from the His angle, using linear staplers with the guidance of a 36 French intragastric bougie.
RYGB
In this group, the bariatric procedure is Roux-en-Y gastric bypass (RYGB), all operations follow the same standard operating procedure.
RYGB
RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
OAGB
In this group, the bariatric procedure is one anastomosis gastric bypass(OAGB), all operations follow the same standard operating procedure.
OAGB
OAGB entails the creation of a long gastric tube by beginning 2 cm below the angular incisure starting from the lesser curvature side and then divided vertically upward by linear cutting staplers as calibrated with a 36 French bougie, followed by the creation of a single gastrojejunal anastomosis with an afferent biliopancreatic limb of 200 cm.
Interventions
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SG
SG involved a vertical gastric resection beginning 4-6 cm from the pylorus and ending 1-2 cm from the His angle, using linear staplers with the guidance of a 36 French intragastric bougie.
RYGB
RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
OAGB
OAGB entails the creation of a long gastric tube by beginning 2 cm below the angular incisure starting from the lesser curvature side and then divided vertically upward by linear cutting staplers as calibrated with a 36 French bougie, followed by the creation of a single gastrojejunal anastomosis with an afferent biliopancreatic limb of 200 cm.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
16 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Beijing Hospital (only for Base-NAFLD)
UNKNOWN
Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD)
UNKNOWN
Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD)
UNKNOWN
Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD)
UNKNOWN
Beijing Chao Yang Hospital
OTHER
Capital Medical University
OTHER
The First Hospital of Kunming
UNKNOWN
Bishan Hospital of Chongqiang Medical University
UNKNOWN
The First Hospital of Hebei Medical University
OTHER
Beijing Friendship Hospital
OTHER
Responsible Party
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Zhongtao Zhang
Director of general surgery, principal investigator
Principal Investigators
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Zhongtao Zhang, M.D.;Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wei L, Li M, Zeng N, Liu Y, Bai R, Zhang N, Song J, Zhang P, Yao Q, Yang Z, Zhao X, Zhang Y, Zhang P, Zhang Z. Bariatric surgery for non-alcoholic fatty liver disease in individuals with obesity (Base-NAFLD): protocol of a prospective multicenter observational follow-up study. BMC Surg. 2021 Jun 24;21(1):298. doi: 10.1186/s12893-021-01296-y.
Other Identifiers
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Base-NAFLD/NASH
Identifier Type: -
Identifier Source: org_study_id
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