Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)

Official title

Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)

Overview

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.

Detailed description

The study will examine whether a modified vertical sleeve gastrectomy (mVSG) will improve GERD and quality of life.

Aim 1 (Primary): to determine whether mVSG, in comparison to conventional vertical sleeve gastrectomy (cVSG), will be associated with lower acid exposure time (AET, measured by the Bravo pH test) at 6-9 months. The investigators hypothesize that, at Month 6-9, compared to cVSG:

• H1. mVSG will be associated with lower AET

Aim 2 (Secondary): To elucidate the mechanistic basis for Aim 1, the investigators will perform following tests, before and at 6-9 months post-surgery: a) High resolution esophageal manometry (HREM) to determine the lower esophageal sphincter (LES) and intragastric pressure; b) The endoluminal functional lumen imaging probe (EndoFLIP) testing to examine changes in compliance of the LES; c) Measure the length of the gastroesophageal flap valve (GEFV) on the retroflex view during endoscopic exam. The investigators hypothesize that, at Month 6-9, compared to cVSG:

* H2a. mVSG will be associated with higher LES pressure and lower intragastric pressure * H2b. mVSG will be associated with lower LES compliance * H2c. GEFV will be present after mVSG (vs absence after cVSG)

Aim 3: Examine the impact of GERD on quality of life (QoL) with two validated rating scales - Gastroesophageal reflux disease-health related quality of life (GERD-HRQL) and Short Form-36 (SF-36). The investigators hypothesize that, at 12 months, compared to cVSG:

• H3. mVSG will lead to superior QoL

Interventions

• Procedure Modified Vertical Sleeve Gastrectomy (mVSG)
  The modified procedure preserves the gastric sling fibers and re-establishes the gastroesophageal flap valve (GEFV).
• Procedure Conventional Vertical Sleeve Gastrectomy (cVSG)
  Vertical Sleeve Gastrectomy as standard procedure

Primary outcome measures

• % Acid Exposure Time (%AET) [Time frame: Pre-surgery, Month 6-9 post surgery]

Secondary outcome measures (4)

• LES pressure [Time frame: Pre-surgery, Month 6-9 post surgery]
• Intragastric pressure [Time frame: Pre-surgery, Month 6-9 post surgery]
• LES compliance [Time frame: Pre-surgery, Month 6-9 post surgery]
• GEFV length [Time frame: Pre-surgery, Month 6-9 post surgery]

Eligibility criteria

Inclusion criteria

• Male and female subjects aged 18-65 years
• Body mass index (BMI) 35-55 kg/m2
• Must meet the BMI criteria before and after 6 months of nonsurgical weight management
• Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
• Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
• Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry and prior to surgery
• Must be able to provide written informed consent

Exclusion criteria

• Hiatal hernia >2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)
• Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
• Severe gastroparesis
• Previous bariatric or anti-reflux procedure
• Barrett's esophagus
• Subjects requiring mesh treatment at time of procedure
• Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
• Subjects with pacemakers, implantable defibrillators, neurostimulators
• Portal hypertension or cirrhosis
• Chronic pancreatitis
• Active cancer treatment
• Inability to tolerate general anesthesia
• Uncontrollable coagulopathy
• Significant and uncontrolled inflammatory bowel disease
• Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.
• Suicidal ideation or unstable/untreated major depressive disorder within the past year
• Alcohol or substance use disorder within the past year.
• Pregnant or breastfeeding or planning pregnancy in the coming 24 months
• Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
• History of, or any current health condition that, in the opinion of the PI, would make the subject ineligible for sleeve gastrectomy, or put the subject at risk by participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• University of California, Irvine — Orange
• University of California, San Diego — San Diego

Identifiers

NCT: NCT06783751 · 3451 · 1R01DK138047-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗