Endoscopic Sleeve Gastroplasty for Non-alcoholic Fatty Liver Disease

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must be taking: Non-selective beta-blockers

Must not be taking: Anticoagulants, Anti-platelets

Disqualifiers: Decompensated cirrhosis, Diabetes, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant or anti-platelet medications. If you have esophageal varices, you can still participate if you are on a non-selective beta-blocker.

What data supports the effectiveness of the treatment P-ESG for non-alcoholic fatty liver disease?

Research shows that endoscopic sleeve gastroplasty (ESG) helps reduce liver fat, improve liver health, and promote weight loss in people with non-alcoholic fatty liver disease (NAFLD). Studies found significant improvements in liver function tests and weight loss after ESG, making it a promising treatment for NAFLD. ^{1 2 3 4 5}

Is endoscopic sleeve gastroplasty (ESG) safe for humans?

Endoscopic sleeve gastroplasty (ESG) is generally considered safe, with a complication rate of less than 2%. There have been rare cases of gallbladder injuries, but these are very uncommon. ^{6 7 8 9 10}

How does the treatment P-ESG differ from other treatments for non-alcoholic fatty liver disease?

P-ESG, or Endoscopic Sleeve Gastroplasty, is unique because it is a minimally invasive procedure that reduces the size of the stomach without incisions, using sutures placed through an endoscope (a flexible tube with a camera and tools). This approach is different from traditional surgical methods and focuses on weight loss, which can indirectly benefit liver health by reducing fat accumulation. ^{10 11 12 13 14}

What is the purpose of this trial?

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increases to 90% in patients with obesity. In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and hepatocellular carcinoma. In 2017, the lifetime costs of caring for NASH patients in the U.S. were estimated at $222.6 billion, with the cost of caring for the advanced NASH (fibrosis stage ≥ 3) being $95.4 billion. It is projected that the number of NASH cases will increase by 63% from 2015 to 2030. Given the weight loss efficacy of Endoscopic Bariatric and Metabolic Therapies (EBMTs), it has been suggested that EBMTs may serve as a novel treatment category for NASH. Previously, the PI and Co-Is studied the effect of Intragastric balloons (IGB)-the oldest EBMT device-on NASH. EUS liver biopsy performed at the time of IGB removal revealed resolution of all NASH histologic features including fibrosis. A follow-up study by a different group showed similar findings. Furthermore, studies have showed the benefits of S-ESG and Aspiration Therapy (AT) on non-histologic features of NASH. Given the greater weight loss experienced after P-ESG compared to IGB (20% vs 10% TWL) and the more reproducible technique and shorter learning curve of the current P-ESG compared to S-ESG, we aim to assess the effect of P-ESG on NASH.

Research Team

Pichamol Jirapinyo, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults aged 18-65 with obesity (BMI > 30) and advanced liver fibrosis or cirrhosis, who have biopsy-proven NASH. It's not for those with diabetes, gastric varices, decompensated cirrhosis, current smokers, or anyone on weight loss programs/medications recently.

Inclusion Criteria

You have a body mass index (BMI) of over 30, which means you are classified as obese.

My liver has advanced scarring.

I have been diagnosed with NASH through a biopsy.

Exclusion Criteria

I have esophageal varices but am taking a beta-blocker for prevention.

My diabetes is confirmed with an HbA1c level of 6.5% or higher.

Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo P-ESG procedure and EUS-LB with EUS-PPG measurement

12 months

Initial procedure visit, followed by regular follow-up visits

Follow-up

Participants are monitored for changes in liver function, quality of life, and other health metrics

12 months

Follow-up visits at months 1, 3, 6, 9, and 12

Extension

Potential long-term follow-up to assess sustained effects of P-ESG

Treatment Details

Interventions

• P-ESG

Trial Overview The study investigates the impact of Endoscopic Sleeve Gastroplasty (ESG) on patients with Non-alcoholic Steatohepatitis (NASH). It will assess changes in liver function and structure through tests like blood work and imaging before and after ESG treatment.

Participant Groups

Group I: Patients with Obesity and NASH scheduled/recommended for P-ESG Procedure Experimental Treatment 5 Interventions

We will perform a 12-month prospective, single-center, pilot observational study on patients with obesity and NASH with advanced fibrosis who are undergoing P-ESG. A total of 15 patients will undergo EUS-LB with EUS-PPG measurement in a single session prior to and at 12 months following P-ESG

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

American Society for Gastrointestinal Endoscopy

Collaborator

Trials

29

Recruited

5,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

Endoscopic sleeve gastroplasty (ESG) is an effective and safe procedure for weight loss, achieving an average total weight loss of 16.3% at 12 months, which is significantly greater than that from intragastric balloon insertion and high-intensity diet therapy.

ESG has a lower rate of adverse events (5.2%) compared to laparoscopic sleeve gastrectomy (16.9%) and intragastric balloon placement (17%), making it a safer option for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and safety of endoscopic sleeve gastroplasty for treating obesity - a systematic review. Due-Petersson, R., Poulsen, IM., Hedbäck, N., et al.[2021]

Endoscopic sleeve gastroplasty (ESG) can be reversed successfully within the first month without significant complications like fibrosis or scarring, indicating a favorable safety profile in the short term.

Despite most sutures dehiscing by 2 years, the procedure still resulted in a sustained reduction in gastric volume, suggesting that ESG can lead to lasting anatomical changes that promote weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing? Runge, TM., Yang, J., Fayad, L., et al.[2021]

Endoscopic sleeve gastroplasty (ESG) is a safe and effective procedure for overweight patients, with a low adverse event rate of only 1.5% and successful completion of all procedures in a study of 189 patients.

Patients experienced significant weight loss, with a mean total weight loss of 12.28% at 6 months and high rates of BMI normalization (76% at 12 months and 86% at 24 months), suggesting ESG can effectively help prevent the progression to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population. Brunaldi, VO., Galvao Neto, M., Sharaiha, RZ., et al.[2023]

Endoscopic sleeve gastroplasty (ESG) led to significant weight loss and improved glycemic control over a 24-month follow-up in 20 patients, with the most notable improvements occurring six months post-procedure.

Unlike traditional surgical methods, ESG did not result in deficiencies in essential vitamins, indicating a safer profile while effectively altering glucose metabolism and positively affecting body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients. Svagera, Z., Machytka, E., Machackova, J., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) is a safe and effective procedure for obesity, showing significant weight loss results with a mean BMI reduction of 9.3 kg/m2 at 6 months and sustained excess body weight loss of 35.6% at 6 months post-procedure.

The study involved 91 patients across six centers, demonstrating that ESG can be successfully implemented in new endobariatric programs, with a mean procedure duration of 85.1 minutes and a short hospital stay of about 27 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study. Sarkar, A., Tawadros, A., Andalib, I., et al.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty - minimally invasive treatment for non-alcoholic fatty liver disease and obesity. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Endoscopic Sleeve Gastroplasty in Non-alcoholic Fatty Liver Disease: a Systematic Review and Meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Improvement in insulin resistance and estimated hepatic steatosis and fibrosis after endoscopic sleeve gastroplasty. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Improvement of nonalcoholic fatty liver disease in morbidly obese patients after sleeve gastrectomy: association of ultrasonographic findings with lipid profile and liver enzymes. [2018]

5. Italy pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty: results from a single surgical bariatric centre. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy with 12+ months of adjuvant multidisciplinary support. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. [2023]

8. Denmark pubmed.ncbi.nlm.nih.gov

Effect and safety of endoscopic sleeve gastroplasty for treating obesity - a systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Gallbladder plication as a rare complication of endoscopic sleeve gastroplasty: A case report. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Redo endoscopic sleeve gastroplasty: technical aspects and short-term outcomes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing? [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population. [2023]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study. [2022]