EndoFLIP Measurement for Sleeve Gastrectomy GERD Prediction

Recruiting at 1 trial location

Overseen By Muhammad Jawad, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Esophagitis, Barrett mucosa, Motility abnormality, Hiatal hernia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some individuals develop acid reflux (GERD) after undergoing sleeve gastrectomy, a weight-loss surgery. Researchers will use the EndoFLIP (Endolumenal Functional Lumen Imaging Probe) during an endoscopy to collect data before the surgery. Eligible participants are adults with a BMI of 30 or more who plan to have sleeve gastrectomy. Participants should not have severe esophagus issues or a history of stomach or esophageal surgery. As an unphased trial, this study offers participants the chance to contribute to understanding GERD development after surgery, potentially improving future patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the EndoFLIP measurement is safe for predicting GERD after sleeve gastrectomy?

Research has shown that EndoFLIP, a tool for examining the inside of the esophagus and stomach, is generally safe. Studies indicate it helps doctors understand how tissues stretch and change shape. This tool has been used in procedures like gastric sleeve surgery and has not been linked to serious side effects. In research, it successfully measured changes during surgeries without major issues. The EndoFLIP system uses a small balloon to gather information, which patients usually tolerate well. While every medical procedure carries some risk, current studies suggest that EndoFLIP is safe for evaluating the digestive system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using EndoFLIP measurements before sleeve gastrectomy to predict GERD because it offers a new way to assess the likelihood of developing this condition after surgery. Unlike standard methods that might wait for symptoms to appear, EndoFLIP provides real-time data on how the stomach's structure and function might change post-surgery. This proactive approach could allow doctors to personalize treatment plans, potentially improving patient outcomes and reducing the occurrence of GERD after sleeve gastrectomy.

What evidence suggests that EndoFLIP measurement is effective for predicting GERD after sleeve gastrectomy?

Research has shown that EndoFLIP, used during an upper endoscopy before sleeve gastrectomy in this trial, can measure the stomach's size and shape during surgery. This tool helps assess the risk of post-surgery issues like stomach narrowing and may help predict reflux disease. However, studies have not yet identified specific EndoFLIP measurements that directly predict acid reflux (GERD) after surgery. EndoFLIP primarily provides real-time measurements of the area where the esophagus meets the stomach. It is a promising tool for monitoring changes during and after surgery, but its direct role in preventing GERD remains under study. ^{1 2 6 7 8}

Who Is on the Research Team?

Omar Ghanem, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a BMI of 30 or more who can consent to the procedure and have no gastric ulcers. It's not for those with severe esophagitis, Barrett's esophagus, peptic strictures, major swallowing muscle problems, large hiatal hernias (>3 cm), or past stomach surgeries.

Inclusion Criteria

Participants can give consent to the procedure

I don't have any stomach ulcers.

BMI 30 or greater kg/m2

Exclusion Criteria

I have severe esophagitis, Barrett's esophagus, or a peptic stricture.

I have had surgery on my esophagus or stomach.

I have a diagnosed esophagus movement disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Subjects undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters for prediction model development

1 week

1 visit (in-person)

Post-operative Follow-up

Subjects may undergo a repeat upper endoscopy with EndoFLIP at 6 months if clinically indicated and complete questionnaires during follow-ups

6 months

1 visit (in-person) if indicated, regular follow-up questionnaires

Long-term Follow-up

Participants complete questionnaires to monitor for gastroesophageal reflux disease and dysphagia up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• EndoFLIP measurement

Trial Overview The study is using EndoFLIP measurement to find ways to predict acid reflux disease after sleeve gastrectomy surgery. Researchers want to see if this tool can help foresee complications related to bariatric surgery.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study of 10 patients undergoing EndoFLIP-assisted laparoscopic esophagomyotomy for achalasia, all patients experienced resolution of dysphagia and postprandial vomiting, indicating effective symptom relief.

The use of EndoFLIP resulted in a significantly shorter operative time (97 minutes) compared to traditional techniques (185 minutes), while achieving similar short-term outcomes, such as discharge on a mechanical soft diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impedance planimetry (EndoFLIP) assisted laparoscopic esophagomyotomy in pediatric population. Howk, AA., Clifton, MS., Garza, JM., et al.[2023]

The use of the EndoFLIP™ probe during laparoscopic fundoplication and hiatal hernia repair provides valuable measurements of esophageal distensibility, which correlate with long-term patient outcomes, particularly regarding symptoms like gas bloat and dysphagia.

Patients with a final distensibility index (DI) between 2.0 and 3.5 mm²/mmHg reported better outcomes, suggesting this range may be optimal for minimizing postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using impedance planimetry (EndoFLIP™) in the operating room to assess gastroesophageal junction distensibility and predict patient outcomes following fundoplication. Su, B., Novak, S., Callahan, ZM., et al.[2022]

In a study of 97 fundoplication surgeries, using a 40 ml balloon volume significantly improved measurements of the gastroesophageal junction, indicating better distensibility and pressure metrics compared to a 30 ml volume.

The study found that patient positioning (reverse Trendelenburg) and the presence of pneumoperitoneum also affected measurements, suggesting that these factors should be standardized to optimize surgical outcomes during fundoplication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a standardized intra-operative endoflip protocol during fundoplication to identify factors that affect distensibility. Su, B., Attaar, M., Wong, H., et al.[2021]

In a study of 103 patients undergoing hiatal hernia repair, a decrease or no change in the distensibility index (DI) with increased balloon volume was significantly associated with a reduction in dysphagia scores after surgery, suggesting improved esophageal function.

The findings indicate that monitoring changes in DI during surgery could serve as a predictive marker for short-term outcomes, particularly in reducing dysphagia, which is a common complication after hiatal hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel EndoFLIP marker during hiatal hernia repair is associated with short-term postoperative dysphagia. Shah, A., Nguyen, DT., Meisenbach, LM., et al.[2022]

Laparoscopic fundoplication (LF) is a well-established surgical treatment for gastroesophageal reflux disease (GERD) with high-volume centers reporting long-term success rates over 90%, but general outcomes are often worse due to variability in techniques.

The EndoFLIP device, which measures the shape and compliance of the gastroesophageal junction during surgery, may help standardize LF procedures and improve outcomes by providing objective data on physiological changes during the operation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acta from the EndoFLIP® Symposium. Perretta, S., McAnena, O., Botha, A., et al.[2014]

The functional lumen imaging probe (Endoflip) effectively measures esophagogastric junction (EGJ) capacity and diameter in real-time during surgeries for achalasia and gastroesophageal reflux disease (GERD), demonstrating significant changes in compliance before and after surgical interventions.

Using Endoflip during procedures like Heller myotomy and Nissen fundoplication allows surgeons to visualize and assess the EGJ's physiological changes dynamically, potentially improving surgical outcomes and aiding in training for esophageal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video. Improving functional esophageal surgery with a "smart" bougie: Endoflip. Perretta, S., Dallemagne, B., McMahon, B., et al.[2012]

In a study of 52 patients with achalasia who underwent peroral endoscopic myotomy (POEM), a lower distensibility index (DI) measured by EndoFLIP after the procedure was linked to a higher rate of incomplete clinical response, indicating its potential as a predictive tool.

The study found that a post-POEM DI below 7 was the strongest predictor of incomplete response, suggesting that monitoring DI can help clinicians assess the effectiveness of POEM in treating achalasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Clinical Outcomes after Peroral Endoscopic Myotomy via Esophageal Distensibility Measurements with the Endoluminal Functional Lumen Imaging Probe. Yoo, IK., Choi, SA., Kim, WH., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39810031/

Role of Endoluminal Functional Lumen Imaging Probe in ... EndoFLIP has some utility in measuring gastric sleeve pouch size during sleeve surgery, assessing gastric sleeve stenosis, predicting the risk of post-sleeve ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.70091

Differences in Functional Lumen Imaging Probe (FLIP) ... While FLIP can provide valuable diagnostic information on esophageal motility, we did not identify any FLIP metrics that clearly predicted GERD ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10289900/

Gastroesophageal Junction and Pylorus Distensibility ... This is the first prospective study assessing pre-, intra-, and 1-year postoperative changes in the GEJ and the pylorus using EndoFlip™ in SG.

4. withpower.com withpower.com/trial/phase-gastroesophageal-reflux-1-2021-c1808

EndoFLIP Measurement for Sleeve Gastrectomy GERD ... The functional lumen imaging probe (Endoflip) effectively measures esophagogastric junction (EGJ) capacity and diameter in real-time during surgeries for ...

5. gastrojournal.org gastrojournal.org/article/S0016-5085(25)00773-5/fulltext

AGA Clinical Practice Update on Incorporating Functional ... The functional lumen imaging probe (FLIP) is a useful diagnostic tool that measures esophageal dimensions and pressures in real time. FLIP panometry is an ...

6. jnmjournal.org jnmjournal.org/journal/view.html?uid=1259&vmd=Full&

Emerging Roles of the Endolumenal Functional Lumen ... The endolumenal functional lumen imaging probe (EndoFLIP) system uses a multi-detector impedance planimetry system to provide data on tissue distensibility and ...

7. springermedicine.com springermedicine.com/metabolic-and-bariatric-surgery/bariatric-surgery/role-of-endoluminal-functional-lumen-imaging-probe-in-bariatric-/50495044

Metabolic and Bariatric Surgery | Role of Endoluminal ... Endoluminal functional luminal impedance planimetry (EndoFLIP) uses impedance planimetry to assess tissue distensibility and geometric changes ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.70187?af=R

Endoluminal Functional Lumen Imaging Probe in the ... This systematic review and meta-analysis defines reference FLIP values in gastroparesis and demonstrates that pyloric distensibility and ...