Effectiveness of Bariatric Surgery for NAFLD/NASH

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.

Conditions

• Bariatric Surgery Candidate
• NAFLD
• NASH With Fibrosis

Interventions

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.

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.

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital

  collaborator OTHER

• Beijing Hospital (only for Base-NAFLD)

  collaborator UNKNOWN

• Beijing Shijitan Hospital, Capital Medical University Beijing Hospital (only for Base-NAFLD)

  collaborator UNKNOWN

• Shanghai Jiao Tong University affiliated Sixth People's Hospital Beijing Hospital (only for Base-NAFLD)

  collaborator UNKNOWN

• Huashan Hospital, Fudan University Beijing Hospital (only for Base-NAFLD)

  collaborator UNKNOWN

• Beijing Chao Yang Hospital

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• The First Hospital of Kunming

  collaborator UNKNOWN

• Bishan Hospital of Chongqiang Medical University

  collaborator UNKNOWN

• The First Hospital of Hebei Medical University

  collaborator OTHER

• Beijing Friendship Hospital

  lead OTHER

Principal Investigators

• Zhongtao Zhang, M.D.;Ph.D. · Beijing Friendship Hospital

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-21

Primary Completion

2024-12-31

Completion

2026-12-31

Countries

• China

Study Locations