Endoscopic Sleeve Gastroplasty for Non-alcoholic Fatty Liver Disease

Overseen By Shailendra Singh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Must not be taking: Anticoagulants, Amiodarone, Tamoxifen, Estrogens

Disqualifiers: Type 1 diabetes, Prior bariatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a weight loss procedure called Endoscopic Sleeve Gastroplasty (ESG) to determine its effectiveness for individuals with severe obesity and nonalcoholic fatty liver disease (NAFLD). The trial aims to assess ESG's impact on weight control, liver health, and overall quality of life. Participants must have a body mass index (BMI) over 30, qualify for ESG, and not have certain other health conditions. The study seeks to address the knowledge gap regarding ESG's effectiveness in these patients. As a Phase 2 trial, it measures ESG's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that endoscopic sleeve gastroplasty is safe for managing obesity in patients with NAFLD?

Research has shown that endoscopic sleeve gastroplasty (ESG) is generally safe for treating obesity. Studies have found complications to be rare, with only about 1.5% to 2.3% of patients experiencing issues like bleeding or a tear in the stomach. This indicates that most people handle the procedure well. Additionally, long-term research suggests that ESG remains safe and effective for up to ten years after completion. Most patients lose significant weight without major side effects. Overall, ESG offers a promising option with a strong safety record for those seeking weight loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), which often involve lifestyle changes or medications to manage symptoms, Endoscopic Sleeve Gastroplasty (ESG) offers a novel approach by physically altering the stomach. This technique involves endoscopic suturing to reduce stomach size, which can lead to significant weight loss—a crucial factor in managing NAFLD and NASH. Researchers are excited about ESG because it is minimally invasive compared to traditional surgical options and may offer a more effective solution for patients struggling to achieve results through diet and exercise alone.

What evidence suggests that endoscopic sleeve gastroplasty might be an effective treatment for obesity with NAFLD?

Research shows that endoscopic sleeve gastroplasty (ESG), the treatment under study in this trial, aids in weight loss, which is crucial for managing nonalcoholic fatty liver disease (NAFLD). Studies have found that patients can maintain significant weight loss for up to 10 years after the procedure. For instance, many patients lose 13% to 20% of their total body weight in the first year. Additionally, about 68% of those who lost more than 25% of their excess weight in the first year managed to keep it off for two years. These findings suggest that ESG is a promising non-surgical option for individuals dealing with obesity and related liver issues like NAFLD. ^{2 6 7 8 9}

Who Is on the Research Team?

Shailendra Singh, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

Inclusion Criteria

Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG

Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)

Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic sleeve gastroplasty (ESG) for weight loss management

6 months

Regular follow-up visits as per study protocol

Follow-up

Participants are monitored for safety, quality of life, and changes in anthropometric, metabolic, and biochemical parameters

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Sleeve Gastroplasty

How Is the Trial Designed?

Group I: Endoscopic Sleeve Gastroplasty Experimental Treatment 1 Intervention

endoscopic suturing of the stomach

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10034804/

Four-year outcomes for endoscopic sleeve gastroplasty from a ...

Our weight loss outcomes showed ESG to be highly effective at promoting weight loss from 1st month to up to 4 years with 90% patients consistently maintaining ...

2.

journals.lww.com

journals.lww.com/ajg/fulltext/2024/10001/s2063_ten_year_outcomes_of_endoscopic_sleeve.2064.aspx

S2063 Ten-Year Outcomes of Endoscopic Sleeve ...

Our results suggest that ESG is effective and safe for treatment of obesity, with durable long-term results for at least up to 10 years after the procedure.

3.

cghjournal.org

cghjournal.org/article/S1542-3565(20)31385-9/fulltext

Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for ...

These weight loss results, with a number needed to treat of 1.1 to achieve TBWL of 5% or more at 5 years, are clinically significant according ...

4.

giejournal.org

giejournal.org/article/S0016-5107(23)02864-X/fulltext

Weight regain after endoscopic sleeve gastroplasty

Subsequent prospective studies have shown a total body weight loss (TBWL) at 12 months after ESG ranging from 13% to 20% and an adverse events ratio of 2%.

5.

gi.org

gi.org/journals-publications/ebgi/kolb_chiang_feb2023/

Endoscopic Sleeve Gastroplasty Is Effective for Patients ...

Of the 60 patients who achieved their goal weight of >25% EWL at 1 year, 41 (68%) had sustained weight loss using the same definition at 2 years ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12566468/

Outcomes of Endoscopic Sleeve Gastroplasty

Safety and early efficacy of endoscopic sleeve gastroplasty (ESG) for obesity in a multi-ethnic Asian population in Singapore. JGH Open ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S187878862400184X

Position statement and guidelines about Endoscopic ...

The safety profile of ESG is consistently supported in the literature. Surgical complications after ESG, ranging from 1.5 to 2.3%, such as bleeding, perforation ...

8.

gut.bmj.com

gut.bmj.com/content/74/Suppl_1/A259.1

P279 Safety and outcomes of endoscopic sleeve ...

13 patients have at least 6 months post procedure follow up. Average total body weight loss at 6, 12 and 24 months was 17.78%, 36% and 26.7% respectively.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7939770/

The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as ...

These results suggest that ESG is a safe and effective option for patients with mild to moderate obesity as well as those with severe. Most previous studies ...