Modified Sleeve Gastrectomy for Acid Reflux

(INNOVATE-VSG Trial)

Recruiting at 1 trial location

Overseen By Ninh T. Nguyen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Hiatal hernia, Barrett's esophagus, others

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

Compensation: Varies

Number of Visits: 5

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a modified version of weight-loss surgery, called Modified Vertical Sleeve Gastrectomy (mVSG), can improve acid reflux, a condition where stomach acid frequently flows back into the esophagus, after the standard sleeve gastrectomy. Participants will receive either the conventional surgery or the new modified version. The trial seeks individuals who have struggled with acid reflux, have a BMI between 35 and 50, and have attempted weight management without surgery for six months. Participants must have health insurance that covers bariatric surgery and related care. As an unphased trial, this study offers a unique opportunity to explore innovative surgical options for those seeking relief from acid reflux.

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

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the modified vertical sleeve gastrectomy (mVSG) is generally safe for individuals who are very overweight and have acid reflux. One study found that this surgery can be performed safely for these patients. However, after a regular sleeve gastrectomy, about 19% of individuals may experience increased acid reflux over time. While the surgery itself is safe, side effects like increased acid reflux can occur later. Participants should consider these findings when deciding to join a clinical trial for mVSG. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard vertical sleeve gastrectomy (VSG), which is commonly used to manage acid reflux by reducing stomach size, the modified vertical sleeve gastrectomy (mVSG) offers a new twist. Researchers are excited about mVSG because it is specifically designed to minimize acid reflux symptoms more effectively than the conventional approach. This modification potentially targets the root of acid reflux issues, offering a promising option for patients who experience persistent symptoms even after the traditional procedure. By addressing these challenges, mVSG could significantly improve patient outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for GERD?

Research has shown that the usual sleeve gastrectomy, a type of weight-loss surgery, can increase acid reflux, also known as GERD. However, recent studies suggest that a modified version of this surgery, called modified vertical sleeve gastrectomy (mVSG), might better control acid reflux. In this trial, participants will undergo either the conventional vertical sleeve gastrectomy (cVSG) or the modified vertical sleeve gastrectomy (mVSG) to compare their effects on GERD. Early observations indicate that the modified surgery significantly improves GERD symptoms for many patients. Some studies report that after this surgery, most people experience a substantial reduction in their GERD symptoms. While the regular sleeve gastrectomy can sometimes worsen GERD, the modified version appears to be a promising option for reducing these symptoms. ^{5 6 7 8 9}

Who Is on the Research Team?

Ninh T. Nguyen, MD

Principal Investigator

University of California, Irvine

Ravinder K. Mittal, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for individuals with obesity who are candidates for sleeve gastrectomy surgery and suffer from gastroesophageal reflux disease (GERD). Participants should not have had previous gastric bypass surgery.

Inclusion Criteria

Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test

I meet the BMI requirements before and after 6 months of weight management without surgery.

Must be able to provide written informed consent

Exclusion Criteria

Subjects with pacemakers, implantable defibrillators, neurostimulators

I need mesh for my upcoming surgery.

I have Barrett's esophagus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either conventional or modified vertical sleeve gastrectomy

1 day

1 visit (in-person)

Post-Surgery Monitoring

Participants are monitored for acid exposure time and other esophageal metrics

6-9 months

Multiple visits (in-person) for tests like Bravo pH, HREM, and EndoFLIP

Quality of Life Assessment

Participants' quality of life is assessed using GERD-HRQL and SF-36 questionnaires

12 months

Visits at Months 4, 6-9, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Modified Vertical Sleeve Gastrectomy (mVSG)

Trial Overview The study compares a new surgical method called modified Vertical Sleeve Gastrectomy (mVSG) to the standard procedure, conventional Vertical Sleeve Gastrectomy (cVSG), to see if mVSG reduces GERD symptoms after surgery.

How Is the Trial Designed?

Group I: Modified Vertical Sleeve Gastrectomy (mVSG) Experimental Treatment 1 Intervention

modified investigational vertical sleeve gastrectomy (mVSG)

Group II: Conventional Vertical Sleeve Gastrectomy (cVSG) Active Control 1 Intervention

conventional vertical sleeve gastrectomy (cVSG)

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3968207/

The effect of bariatric surgery on gastroesophageal reflux ... Laparoscopic sleeve gastrectomy has been associated with an increased incidence of GERD following the procedure; explanations have included the postoperative ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2049080122003442

The new onset of GERD after sleeve gastrectomy The most recent studies have shown satisfactory control of postoperative reflux in most patients and low rates of de novo GERD.

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1463567/full

Surgical treatment strategies for gastroesophageal reflux ... A meta-analysis encompassing three studies has revealed that patients who underwent MSA experienced an average reduction of 17.5 points in their ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70094

Comparative efficacy of sleeve gastrectomy with ... According to preliminary observations, the mean improvement in GERD-Q score at 6 months postoperatively was approximately 2 points in the LSGFD ...

5. link.springer.com link.springer.com/article/10.1007/s00464-024-11303-x

An updated meta-analysis and systematic review of 5-year ... Five RCTs were analysed (LVSG n = 554, LRYGB n = 539). LVSG was associated with increased adverse GERD outcomes compared to LRYGB at 5 years.

6. ales.amegroups.org ales.amegroups.org/article/view/10041/html

Surgical options for refractory gastroesophageal reflux ... A meta-analysis of studies with 7 or more years of outcomes for sleeve gastrectomy showed a dramatic rise in the revision rate of patients with LSG. Five ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878788623000061

Obesity, sleeve gastrectomy and gastro-esophageal reflux ... In this update, we address the association between obesity and GERD, the impact of GERD on the indication for surgery, the mechanisms, the prevalence and ...

8. oaepublish.com oaepublish.com/articles/2574-1225.2024.105

Gastroesophageal reflux disease related to laparoscopic ... The pooled prevalence of increasing GERD after SG was 19%, including in subgroup analyses of studies reporting long-term outcomes over 24 months ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716307/

Gastroesophageal reflux related changes after sleeve ... Despite several limitations, this study highlights that the LSGFD is a feasible and safe procedure in patients who are morbidly obese with GERD, ...