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Идёт набор NCT04366999

Effectiveness of Bariatric Surgery for NAFLD/NASH

— Наблюдательное Bariatric Surgery Candidate NAFLD NASH With Fibrosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SG, RYGB, OAGB.
Кому может быть актуально
Состояния в реестре: Bariatric Surgery Candidate, NAFLD, NASH With Fibrosis. Базовые параметры: 16 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases/Nonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study

Обзор

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.

Вмешательства

  • Процедура 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.
  • Процедура RYGB
    RYGB entails the creation of a 15-30 mL (approximate) gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb.
  • Процедура 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.

Первичные конечные точки

  • the remisson rate of NAFLD (for Base-NAFLD cohort) [Срок оценки: 1 years after surgery]
  • Histological remission of NASH without worsening of fibrosis (for Base-NASH cohort) [Срок оценки: 1 years after surgery]
Вторичные конечные точки (5)
  • the rate of fibrosis improvement without NASH worsening [Срок оценки: 1 year after surgery]
  • changes in NASH and liver fbrosis biopsy fndings [Срок оценки: 1 year after surgery]
  • changes in body weight [Срок оценки: 3 months, 6 months, and 1 year after surgery]
  • resolution of obesity-related comorbidities [Срок оценки: 1 year after surgery]
  • incidence of adverse health events [Срок оценки: 1 year after surgery]

Критерии участия

Критерии включения

\[For Base-NAFLD\]

  • Age between 16 and 65 years (all sexes).
  • 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.
  • 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.

\[For Base-NASH\]

  • Age between 16 and 65 years (all sexes).
  • 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.
  • Histologically confirmed NASH with fibrosis:

NAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Friendship Hospital — Пекин

Публикации

  • 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. PMID 34167531

Идентификаторы

NCT: NCT04366999 · Base-NAFLD/NASH

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗