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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treat non-alcoholic steatohepatitis (NASH), a severe liver disease that can cause liver damage. The treatment under investigation is Endoscopic Sleeve Gastroplasty (P-ESG), which has shown promise in aiding weight loss and improving liver health. The trial targets individuals with obesity who have been diagnosed with NASH, particularly those with advanced liver scarring (fibrosis). Participants will undergo the P-ESG procedure and have their liver health monitored over a year to assess its effectiveness. The study aims to provide new insights into managing NASH and its complications. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for NASH.

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 prior data suggests that the P-ESG procedure is safe for patients with obesity and NASH?

Research has shown that Endoscopic Sleeve Gastroplasty (ESG) is a safe method for weight loss. Studies have found it effectively aids weight loss in individuals with conditions like non-alcoholic steatohepatitis (NASH) and obesity. Participants in these studies did not experience serious side effects, indicating the procedure is generally well-tolerated. ESG also improves liver health in individuals with liver issues, such as those seen in NASH. Overall, evidence supports ESG as a safe and effective option for managing weight and enhancing liver health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Endoscopic Sleeve Gastroplasty (P-ESG) is unique because it offers a non-surgical, endoscopic approach to treating Non-alcoholic Fatty Liver Disease (NAFLD) in patients with obesity and advanced fibrosis, unlike traditional treatments that often involve lifestyle changes, medication, or invasive surgery. This technique involves reshaping the stomach from within, reducing its size and limiting food intake, which can lead to significant weight loss and potential improvement in liver health. Researchers are excited about P-ESG because it combines the benefits of a less invasive procedure with the potential to more directly address the obesity factor contributing to NAFLD, offering hope for better outcomes with less recovery time.

What evidence suggests that P-ESG might be an effective treatment for NASH?

Research shows that Endoscopic Sleeve Gastroplasty (ESG) holds promise for treating non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic steatohepatitis (NASH). Studies have found that ESG can lead to significant weight loss, with some patients losing up to 27.2% of their body weight. This weight loss is crucial because it can reduce liver stiffness, a key factor in the progression of NAFLD and NASH. Other research has demonstrated that patients undergoing ESG experience a noticeable decrease in liver stiffness, which is linked to improved liver health. Overall, these findings suggest that ESG might be an effective option for those dealing with NAFLD and NASH. Participants in this trial will undergo the P-ESG procedure to further evaluate its impact on patients with obesity and NASH. ^{1 2 5 6 7}

Who Is on the Research Team?

Pichamol Jirapinyo, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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) 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39694202/

Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention ... We report the results of a multicenter, randomized, controlled, and double-blind study to evaluate the effectiveness and safety of ESG in patients with MASH.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05507151

Effectiveness of Endoscopic Sleeve Gastroplasty in ... Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/​Nonalcoholic Steatohepatitis. ClinicalTrials.gov ID NCT05507151.

3. cghjournal.org cghjournal.org/article/S1542-3565(24)01080-2/fulltext

Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention ... Total body weight loss (TBWL) was 9.47% (±9.38%) in the ESG group vs 3.91% (±5.43%) in the ESI group (P < .05). Liver stiffness decreased 5.63 ( ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356524010802

Endoscopic Sleeve Gastroplasty Plus Lifestyle Intervention ... Total body weight loss (TBWL) was 9.47% (±9.38%) in the ESG group vs 3.91% (±5.43%) in the ESI group (P < .05). Liver stiffness decreased 5.63 (±7.17) KPa in ...

5. igiejournal.org igiejournal.org/article/S2949-7086(25)00040-8/fulltext

Safety and efficacy of endoscopic sleeve gastroplasty after ... Median follow-up after ESG was 18.8 months (IQR, 8.2-19.8 months). Median total body weight loss was 27.2% (IQR, 8.0%-30.0%) at the end of follow-up. Weight ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37537506/

Impact of Endoscopic Sleeve Gastroplasty in Non-alcoholic ... The results showed a significant (p < 0.05) reduction of 4.85 in hepatic steatosis index (95% CI - 6.02, - 3.67), 0.5 in NAFLD fibrosis score (95% CI - 0.80, - ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04820036

A Physiologic Analysis of Endoscopic Sleeve Gastroplasty ... In 25% of patients, NAFLD progresses to a more severe form-non-alcoholic steatohepatitis (NASH)-which further increases the risks of cirrhosis and ...