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

Trial Summary

What is the purpose of this trial?

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

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 data supports the effectiveness of the treatment EndoFLIP measurement for predicting GERD after sleeve gastrectomy?

Research suggests that the EndoFLIP device, which measures the shape and flexibility of the gastroesophageal junction (where the stomach meets the esophagus), can improve surgical outcomes in procedures like fundoplication for GERD. This implies it might help predict GERD after sleeve gastrectomy by providing real-time measurements during surgery. ^{1 2 3 4 5}

Is EndoFLIP safe for use in humans?

EndoFLIP has been used safely in various surgeries, such as fundoplication and esophagomyotomy, to measure the esophagus and stomach junction. It has been used internationally for several years without reported safety issues. ^{1 2 3 4 6}

How does the EndoFLIP treatment for GERD differ from other treatments?

EndoFLIP is unique because it uses a special probe to measure the flexibility and size of the esophagus in real-time during surgery, which can help predict and improve outcomes for GERD (gastroesophageal reflux disease) treatment. This approach is different from traditional methods that do not provide such detailed, immediate feedback during the procedure. ^{1 2 5 6 7}

Research Team

Omar Ghanem, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

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

Video. Improving functional esophageal surgery with a "smart" bougie: Endoflip. [2012]

2. Germany pubmed.ncbi.nlm.nih.gov

Using a standardized intra-operative endoflip protocol during fundoplication to identify factors that affect distensibility. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Using impedance planimetry (EndoFLIP™) in the operating room to assess gastroesophageal junction distensibility and predict patient outcomes following fundoplication. [2022]

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

Acta from the EndoFLIP® Symposium. [2014]

5. Germany pubmed.ncbi.nlm.nih.gov

A novel EndoFLIP marker during hiatal hernia repair is associated with short-term postoperative dysphagia. [2022]

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

Impedance planimetry (EndoFLIP) assisted laparoscopic esophagomyotomy in pediatric population. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Assessment of Clinical Outcomes after Peroral Endoscopic Myotomy via Esophageal Distensibility Measurements with the Endoluminal Functional Lumen Imaging Probe. [2020]