EndoFLIP Measurement for Sleeve Gastrectomy GERD Prediction
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byOmar Ghanem, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Esophagitis, Barrett mucosa, Motility abnormality, Hiatal hernia, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
12346How 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.
12567Eligibility 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
+1 more
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.
+1 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Orlando HealthOrlando, FL
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Video. Improving functional esophageal surgery with a "smart" bougie: Endoflip. [2012]An emerging imaging tool, the functional lumen imaging probe (Endoflip; Crospon Ltd, Galway, Ireland), provides a real-time measurement of esophagogastric junction (EGJ) capacity and diameter, which would be of particular interest in functional esophageal surgery such as Heller myotomy and antireflux procedures. This study aimed to demonstrate the intraoperative use of endoflip in the treatment of achalasia and gastroesophageal reflux disease (GERD).
Using a standardized intra-operative endoflip protocol during fundoplication to identify factors that affect distensibility. [2021]The Endoluminal Functional Lumen Imaging Probe (Endoflip) can be used to provide objective measurements of the gastroesophageal junction during fundoplication, and recent publications have suggested that this device could improve surgical outcomes. However, the impact of operative variables has not been clearly reported. The aim of this study is to determine the effect of these variables on functional lumen imaging probe (FLIP) measurements.
Using impedance planimetry (EndoFLIP™) in the operating room to assess gastroesophageal junction distensibility and predict patient outcomes following fundoplication. [2022]The purpose of this study is to evaluate the utility of using a functional lumen imaging probe (EndoFLIP™) intra-operatively during hiatal hernia repair and fundoplication. Additionally, we hypothesize that these measurements correlate with long-term outcomes.
Acta from the EndoFLIP® Symposium. [2014]Laparoscopic fundoplication (LF) is a surgical treatment for gastroesophageal reflux disease (GERD) that has been performed for more than 20 years. High-volume centers of excellence report long-term success rates greater than 90% with LF. On the other hand, general population-based outcomes are reported to be markedly worse, leading to a nihilistic perception of the procedure on the part of the medical referral population. The lack of standardization of the technique and the lack of tools to calibrate objectively the repairs are probably among the causes of variability in the outcomes and may explain the decline in the number of LF procedures in recent years. The functional lumen imaging probe (EndoFLIP(®)) device is essentially a "smart bougie" in the form of a balloon catheter that measures shape and compliance of the gastroesophageal junction (GEJ) during surgery using impedance planimetry. With approximately 3 years of international experience gained with this tool, a symposium was convened in October 2012 in Strasbourg, France, with the aim of determining if intraoperative EndoFLIP use could provide standardization of surgical treatment of GERD through the understanding of physiological changes occurring to the GEJ during fundoplication. This article provides a brief history of the EndoFLIP system and reviews data previously published on the use of EndoFLIP to characterize the GEJ in normal subjects. It then summarizes the data from the 5 high-volume international sites with expert surgeons performing LF presented in Strasbourg to objectively profile the characteristics of a normal postoperative GEJ.
A novel EndoFLIP marker during hiatal hernia repair is associated with short-term postoperative dysphagia. [2022]Endoluminal functional lumen imaging probe (EndoFLIP) provides an objective measure of the distensibility index (DI) during different parts of hiatal hernia repair. However, the absolute DI measure above a cut-off after creating a barrier alone has not shown a relationship to dysphagia after surgery. We wanted to determine if the change in DI with volume change is associated with dysphagia.
Impedance planimetry (EndoFLIP) assisted laparoscopic esophagomyotomy in pediatric population. [2023]Functional lumen imaging probe (EndoFLIP) is a diagnostic technology that assesses esophageal cross-sectional area via impedance planimetry during controlled volumetric distention. The purpose of this study is to evaluate the utility of EndoFLIP intraoperatively during laparoscopic esophagomyotomy.
Assessment of Clinical Outcomes after Peroral Endoscopic Myotomy via Esophageal Distensibility Measurements with the Endoluminal Functional Lumen Imaging Probe. [2020]Endoluminal functional lumen imaging probe (EndoFLIP) is a modality that enables clinicians to measure volume-controlled distension of the esophagus. This study aimed to assess the utility of EndoFLIP in patients who had achalasia treated with peroral endoscopic myotomy (POEM). We hypothesized that improvement in the distensibility index (DI) is correlated with the postoperative clinical outcome of POEM.