Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Location contact
Zhongtao Zhang, M.D.;Ph.D.
CONTACT
Zhongtao Zhang, M.D.;Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04366999
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.
Interested in participating?
Request Info16 year–65 year
All sexes
Observational
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Zhongtao Zhang, M.D.;Ph.D.
CONTACT
Zhongtao Zhang, M.D.;Ph.D.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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 entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
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.
Time frame: 1 years after surgery
Percentage of liver fat content <5% of abdominal magnetic resonance imaging(MRI) at 1 year after surgery.
Visit : Post-op 12 months (±30 Days)
Time frame: 1 years after surgery
*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.
Time frame: 1 year after surgery
NASH worsening, was defined as an increase of ≥1 point in either the lobular inflammation score or the hepatocyte ballooning score.
Time frame: 1 year after surgery
2.including the NAS (NAFLD activity score) and SAF scores (steatosis [S], activity [A], and fbrosis [F]) .
Time frame: 3 months, 6 months, and 1 year after surgery
Time frame: 1 year after surgery
4.blood glucose levels, lipid levels, and liver enzyme levels.
Time frame: 1 year after surgery
Including but not limited to bleeding, ulcer, intestinal obstruction etc.
Contact information is provided by the study sponsor or research team.
Mengyi Li, M.D.;Ph.D.
CONTACT
Zhongtao Zhang, M.D.;Ph.D.
CONTACT
Beijing Friendship Hospital
Other
Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03025074
Bariatric Surgery Candidate, Blood-Borne Infections
Buffalo, New York, United States
View Trial DetailsNCT03997422
Bariatric Surgery Candidate, Body Weight
Minneapolis, Minnesota, United States
View Trial DetailsNCT06499675
Bariatric Surgery Candidate, Body Weight
Sherbin, Dakahlia Governorate, Egypt
View Trial DetailsNCT03391401
Bariatric Surgery Candidate, Body Weight
Bonn, Germany
View Trial Details