Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Beijing Hospital (only for Base-NAFLD) | UNKNOWN |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD) |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SG | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the remisson rate of NAFLD (for Base-NAFLD cohort) | Percentage of liver fat content <5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery. Visit : Post-op 12 months (±30 Days) | 1 years after surgery |
| Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort) | *NASH resolution was defined as presence of a CRN inflammation score of 0 or 1 and no hepatocyte ballooning (score of 0). **Worsening of fibrosis was defined as an increase of one stage or more on the NASH-CRN fibrosis score at 1-year follow-up. | 1 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of fibrosis improvement without NASH worsening | NASH worsening, was defined as an increase of ≥1 point in either the lobular inflammation score or the hepatocyte ballooning score. | 1 year after surgery |
| changes in NASH and liver fbrosis biopsy fndings |
Not provided
Inclusion Criteria:
[For Base-NAFLD]
[For Base-NASH]
NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1
Exclusion Criteria:
Not provided
Not provided
The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongtao Zhang, M.D.;Ph.D. | Contact | +86-13801060364 | zhangzht@ccmu.edu.cn | |
| Mengyi Li, M.D.;Ph.D. | Contact | +86-15810993198 | limengyi@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongtao Zhang, M.D.;Ph.D. | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34167531 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Paired liver biopsy: Intraoperative, at least 1-year after surgery
| RYGB | Procedure | RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb. |
|
| OAGB | Procedure | 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. |
|
2.including the NAS (NAFLD activity score) and SAF scores (steatosis [S], activity [A], and fbrosis [F]) . |
| 1 year after surgery |
| changes in body weight |
| 3 months, 6 months, and 1 year after surgery |
| resolution of obesity-related comorbidities | 4.blood glucose levels, lipid levels, and liver enzyme levels. | 1 year after surgery |
| incidence of adverse health events | Including but not limited to bleeding, ulcer, intestinal obstruction etc. | 1 year after surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |