Modified Sleeve Gastrectomy for Acid Reflux

(INNOVATE-VSG Trial)

Recruiting at 1 trial location

Overseen By Ninh T. Nguyen, MD

Age: 18 - 65

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

Trial Summary

What is the purpose of this trial?

This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.

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.

What data supports the effectiveness of the treatment Modified Vertical Sleeve Gastrectomy (mVSG) for acid reflux?

The research suggests that traditional sleeve gastrectomy can lead to increased acid reflux, but a new technique combining a long, narrow gastroplasty with an antireflux procedure may help avoid this complication. ^{1 2 3 4 5}

How does the treatment Modified Vertical Sleeve Gastrectomy (mVSG) for acid reflux differ from other treatments?

The Modified Vertical Sleeve Gastrectomy (mVSG) is a surgical treatment that may offer a unique approach to managing acid reflux by altering the stomach's structure, potentially reducing acid production and reflux. Unlike medications that primarily focus on neutralizing or reducing stomach acid, this surgical method addresses the physical cause of reflux. ^{6 7 8 9 10}

Research Team

Ninh T. Nguyen, MD

Principal Investigator

University of California, Irvine

Ravinder K. Mittal, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Preoperative esophageal testing predicts postoperative reflux status in sleeve gastrectomy patients. [2023]

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

Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. [2022]

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

Gastroesophageal reflux disease following laparoscopic vertical sleeve gastrectomy and laparoscopic roux-en-Y gastric bypass: meta-analysis and systematic review of 5-year data. [2023]

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

Antireflux sleeve gastroplasty: description of a novel technique. [2019]

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

Can lower preoperative 48-hour pH score predict reflux resolution after sleeve gastrectomy. [2021]

6. China pubmed.ncbi.nlm.nih.gov

Left lower sleeve lobectomy and systematic lymph node dissection by complete video-assisted thoracic surgery. [2020]

7. China pubmed.ncbi.nlm.nih.gov

Video-assisted thoracoscopic surgery: pneumonectomy for synchronous primary lung malignancies. [2023]

8. China pubmed.ncbi.nlm.nih.gov

Initial experience of single-port video-assisted thoracoscopic surgery sleeve lobectomy and systematic mediastinal lymphadenectomy for non-small-cell lung cancer. [2020]

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

Long-term survival after enucleation of a giant esophageal gastrointestinal stromal tumor. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Role of video-assisted thoracic surgery for the treatment of myasthenia gravis: extended thymectomy by median sternotomy versus the thoracoscopic approach with sternal lifting. [2013]