TY - JOUR
T1 - Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis
AU - Bazerbachi, Fateh
AU - Vargas, Eric J.
AU - Rizk, Monika
AU - Maselli, Daniel B.
AU - Mounajjed, Taofic
AU - Venkatesh, Sudhakar K.
AU - Watt, Kymberly D.
AU - Port, John D.
AU - Basu, Rita
AU - Acosta, Andres
AU - Hanouneh, Ibrahim
AU - Gara, Naveen
AU - Shah, Meera
AU - Mundi, Manpreet
AU - Clark, Matthew
AU - Grothe, Karen
AU - Storm, Andrew C.
AU - Levy, Michael J.
AU - Abu Dayyeh, Barham K.
N1 - Publisher Copyright:
© 2021 AGA Institute
PY - 2021/1
Y1 - 2021/1
N2 - Background & Aims: Obese 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. Methods: Twenty-one patients with early hepatic fibrosis (81% female; mean age, 54 years; average body mass index, 44 kg/m2) underwent magnetic resonance elastography (MRE) and endoscopic ultrasound with core liver biopsy collection at time IGB placement and removal at a single center from October 2016 through March 2018. The primary outcome measure was the changes in liver histology parameters after IGB, including change in nonalcoholic fatty liver disease activity score (NAS) and fibrosis score. We also evaluated changes in weight, body mass index, waist to hip ratio, aminotransaminases, fasting levels of lipids, fasting glucose, glycosylated hemoglobin, and MRE-detected liver stiffness. Results: Six 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. Conclusion: In 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
AB - Background & Aims: Obese 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. Methods: Twenty-one patients with early hepatic fibrosis (81% female; mean age, 54 years; average body mass index, 44 kg/m2) underwent magnetic resonance elastography (MRE) and endoscopic ultrasound with core liver biopsy collection at time IGB placement and removal at a single center from October 2016 through March 2018. The primary outcome measure was the changes in liver histology parameters after IGB, including change in nonalcoholic fatty liver disease activity score (NAS) and fibrosis score. We also evaluated changes in weight, body mass index, waist to hip ratio, aminotransaminases, fasting levels of lipids, fasting glucose, glycosylated hemoglobin, and MRE-detected liver stiffness. Results: Six 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. Conclusion: In 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
KW - Bariatric Endoscopy
KW - Diabetes
KW - NAFLD
KW - Nonalcoholic fatty liver disease
KW - Obesity
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U2 - 10.1016/j.cgh.2020.04.068
DO - 10.1016/j.cgh.2020.04.068
M3 - Article
C2 - 32360804
AN - SCOPUS:85097766408
SN - 1542-3565
VL - 19
SP - 146-154.e4
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 1
ER -