Evidence map›Paper›PMID 32360804›Full record

Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2021

Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis.

Fateh Bazerbachi, Eric J Vargas, Monika Rizk, Daniel B Maselli, Taofic Mounajjed, Sudhakar K Venkatesh, Kymberly D Watt, John D Port, Rita Basu, Andres Acosta and 9 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 47 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 6 pooled it
11.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02880189 nacompletednot on this map

Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity

TypeinterventionalSponsorMayo ClinicRan2016 to 2018Enrolled21ConditionsObesity, Non-Alcoholic SteatohepatitisArmsOrbera Intragastric Balloon, Endoscopic Ultrasound Guided Core Liver Biopsy
NCT07493967 enrolling by invitationnot on this mapstarted 2024, after this paper: background citation

Short and Long Term Clinical and Patient-Reported Outcomes Associated With Intragastric Balloon Placement in Patients With Nonalcoholic Fatty Liver Disease

TypeobservationalSponsorMethodist Health SystemRan2024 to 2027Enrolled200ConditionsNAFLD
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 6 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. AGA Clinical Practice Update on Bariatric Surgery in Cirrhosis: Expert Review.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021
    Guideline
  7. Trial
  8. Trial
  9. Article
  10. Management of obesity in advanced chronic liver disease.JHEP reports : innovation in hepatology · 2026
    Review
  11. Review
  12. Review
  13. Advances and future directions in endoscopic bariatric therapies.World journal of gastrointestinal endoscopy · 2025
    Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Endoscopic tips for intragastric balloon use for obesity: what you need to know.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2024
    Review
  19. Endobariatric systems: Strategic integration of endoscopic therapies in the management of obesity.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Review
  20. How to incorporate endohepatology into your bariatric practice.iGIE : innovation, investigation and insights · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 3 institutions in 1 country.

Fateh BazerbachiDivision of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
Eric J VargasDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Monika RizkDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Daniel B MaselliDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Taofic MounajjedDepartment of Pathology, Mayo Clinic, Rochester, Minnesota.
Sudhakar K VenkateshDepartment of Radiology, Mayo Clinic, Rochester, Minnesota.
Kymberly D WattDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
John D PortDepartment of Radiology, Mayo Clinic, Rochester, Minnesota.
Rita BasuDivision of Endocrinology, Department of Medicine, University of Virginia School of Medicine, Charlottesville, Virginia.
Andres AcostaDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Ibrahim HanounehDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Naveen GaraGastroenterology and Liver Institute, Escondido, California.
Meera ShahDivision of Endocrinology, Mayo Clinic, Rochester, Minnesota.
Manpreet MundiDivision of Endocrinology, Mayo Clinic, Rochester, Minnesota.
Matthew ClarkDivision of Endocrinology, Mayo Clinic, Rochester, Minnesota.
Karen GrotheDivision of Endocrinology, Mayo Clinic, Rochester, Minnesota.
Andrew C StormDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Michael J LevyDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Barham K Abu DayyehDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: abudayyeh.barham@mayo.edu.
Mayo Clinic · USMassachusetts General Hospital · USUniversity of Virginia · US

Funding

Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
MECHANISMS OF INSULIN RESISTANCE IN MANR01DK029953 · NIDDK · UNIVERSITY OF VIRGINIA · PI BASU, RITA · 1986 to 2024
$11.5M
Magnetic Resonance ElastographyR37EB001981 · NIBIB · MAYO CLINIC ROCHESTER · PI EHMAN, RICHARD L. · 2016 to 2025
$4.0M
NCATS NIH HHS UL1 TR000135NIBIB NIH HHS R37 EB001981NIDDK NIH HHS R01 DK029953
6 · The paper itself

Abstract

BACKGROUND &

aimsObese patients with nonalcoholic steatohepatitis (NASH) are at risk for cirrhosis if significant weight loss is not achieved. The single fluid-filled intragastric balloon (IGB) induces meaningful weight loss and might be used in NASH treatment. We performed an open-label prospective study to evaluate the effects of IGB placement on metabolic and histologic features of NASH.

methodsTwenty-one patients with early hepatic fibrosis (81% female; mean age, 54 years; average body mass index, 44 kg/m

resultsSix months after IGB, patients' mean total body weight loss was 11.7% ± 7.7%, with significant reductions in HbA1c (1.3% ± 0.5%) (P = .02). Waist circumference decreased by 14.4 ± 2.2 cm (P = .001). NAS improved in 18 of 20 patients (90%), with a median decrease of 3 points (range, 1-4 points); 16 of 20 patients (80%) had improvements of 2 points or more. Fibrosis improved by 1.17 stages in 15% of patients, and MRE-detected fibrosis improved by 1.5 stages in 10 of 20 patients (50%). Half of patients reached endpoints approved by the Food and Drug Administration of for NASH resolution and fibrosis improvement. Percent total body weight loss did not correlate with reductions in NAS or fibrosis. Other than post-procedural pain (in 5% of patients), no serious adverse events were reported.

conclusionIn a prospective study, IGB facilitated significant metabolic and histologic improvements in NASH. IGB appears to be safe and effective for NASH management when combined with a prescribed diet and exercise program. ClinicalTrials.gov no: NCT02880189.

Indexed as

Gastric BalloonNon-alcoholic Fatty Liver DiseaseFemaleHumansLiverMaleMiddle AgedProspective StudiesWeight LossBariatric EndoscopyDiabetesNAFLDNonalcoholic fatty liver diseaseObesity

Identifiers

PMID32360804
PMCPMC8106130
OpenAlexW3021927711

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.