Bariatric Surgery Effect Nonalcoholic Fatty Liver Disease

Bariatric Surgery Effect Nonalcoholic Fatty Liver Disease: a Prospective Cohort Study

This is a prospective cohort study, which subjects were obese patients requiring bariatric surgery.

The bariatric procedures include laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and one anastomosis gastric bypass-mini gastric bypass (OAGB-MGB).

The main observation is the cure rate of NAFLD:percentage of liver fat content <5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery.

In addition, secondary observations include the excess weight loss (%EWL), total weight loss(%TWL), change of HbA1c, level of insulin resistance, blood lipid level alanine aminotransferase(ALT), liver fat fraction in MRI, alpha-fetoprotein and liver pathology.

Aim to prove that bariatric surgery can effectively cure obese NAFLD.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver; Non-Alcoholic Fatty Liver Disease; Complication of Bariatric Procedure
• Intervention / Treatment: Procedure: LSG; Procedure: LRYGB; Procedure: OAGB-MGB

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Zhongtao Zhang, M.D.;Ph.D.; Phone Number: +86-13801060364; Email: zhangzht@ccmu.edu.cn
• Study Contact Backup: Name: Mengyi Li, M.D.; Phone Number: +86-15810993198; Email: limengyi@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Zhongtao Zhang, M.D.;Ph.D.; Phone Number: +86-13801060364; Email: zhangzht@ccmu.edu.cn
      • Principal Investigator: Zhongtao Zhang, M.D.;Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will comprise male and non-pregnant female patients, aged 16-65years both inclusive, with morbid obesity.

Description

Inclusion Criteria:

• Patients were accepted for surgery if they satisfied the guidelines of the Society of Chinese Gastroenterological Surgeons [body mass index (BMI) ≥32.5 kg/m2 or 27.5 ≤BMI ≤32.5 kg/m2 with at least one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea), and failure of conservative treatment over 2 years].Especially with type 2 diabetes, the recommended level of surgery can be increased as appropriate（≥ 25kg/m2）.
• Imaging or pathological findings suggest liver steatosis: i. Preoperative abdominal ultrasound showed fatty liver; ii. Preoperative abdominal magnetic resonance showed liver fat content ≥5%; iii. Intraoperative liver pathology suggests the presence of liver steatosis.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LSG; In this group, the bariatric procedure is laparoscopic sleeve gastrectomy (LSG), all operations follow the same standard operating procedure.	Procedure: LSG; The operation was started by replacing the 12-mm bladed trocar, and two additional trocars were inserted. LigaSure was used to dissect the omental pieces of the great curvature and any adhesions of the pancreas and stomach. A 36-French orogastric tube was then placed in the stomach. Gastric transection was started at a distance of approximately 4cm from the pylorus using a stapler (EndoGIA™; Covidien). All stapling was performed with yellow/green/black/blue cartridges. The staple line was reinforced with continuous barbed prolene sutures, and any sites of bleeding were closed with the LigaSure device. The portion of the stomach that had been transected from the pylorus was extracted through the 12-mm trocar site.
LRYGB; In this group, the bariatric procedure is laparoscopic Roux-en-Y gastric bypass (LRYGB), all operations follow the same standard operating procedure.	Procedure: LRYGB; LRYGB is performed as described as standard. In brief, smaller stomach pouch of 10 to 20 ml or larger stomach pouch of 25 to 35 ml were created according to the metabolic status of the patients. The jejunum at approximately 150 cm distal site was dragged up and connected (anastomosed) to the remnant stomach.
OAGB-MGB; In this group, the bariatric procedure is one anastomosis gastric bypass-mini gastric bypass(OAGB-MGB), all operations follow the same standard operating procedure.	Procedure: OAGB-MGB; Four ports are placed generally. The"paddle"retractor is used to retract the liver. The GIA stapler divides the stomach at the junction of the body and antrum, at a location where the jejunal loop can be brought up comfortably. With 4-6 lines of staples that seal the gastric pouch. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 150 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to anastomose the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel. The inside of the anastomosis is inspected for bleeding before final closure. The stapler then closes the anatomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the cure rate of NAFLD	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The excess weight loss (%EWL) after surgery	Percent excess weight loss (%EWL), %EWL=[(initial weight)-(post-op weight)]/[(initial weight)-(ideal weight)] (in which "ideal weight" is defined by the weight corresponding to a BMI of 25 kg/m2). Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
The total weight loss (%TWL) after surgery	Percent total weight loss (%TWL), %TWL=[(initial weight)-(post-op weight)]/initial weight. Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
The change of HBA1c	The change of HbA1c Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
The change of level of insulin resistance	The change of level of insulin resistance Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
The change of blood lipid level	The change of blood lipid level, including cholesterin, triglyceride, low-density lipoprotein, high-density lipoprotein, etc. Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
The change of alanine aminotransferase(ALT)	The change of alanine aminotransferase(ALT) Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
The change of alpha-fetoprotein	The change of alpha-fetoprotein Visit 1: Baseline Visit (Day 0-1) Visit 2: Post-op 3 months(±7 Days) Visit 3: Post-op 6 months(±14 Days) Visit 4: Post-op 12 months (±30 Days) Visit 5:Post-op 24 months (±30 Days)	2 years after surgery
Liver puncture pathology	The investigators collect the liver puncture pathology in one year after surgery and completing NAFLD activity score(NAS) at the same time. The scoring system comprised 14 histological features, 4 of which were evaluated semi-quantitatively: steatosis (0-3), lobular inflammation (0-2), hepatocellular ballooning (0-2), and fibrosis (0-4). Another nine features were recorded as present or absent. NAS of > or =5 correlated with a diagnosis of NASH, and biopsies with scores of less than 3 were diagnosed as "not NASH." Visit: Post-op 12 months (±30 Days)	1year after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Tiantan Hospital; Huashan Hospital; Beijing Hospital; Beijing Shijitan Hospital, Capital Medical University; Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Principal Investigator: Zhongtao Zhang, M.D.;Ph.D., Beijing Friendship Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 26, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Bariatric surgery; NAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: Base-NAFLD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No