Gastroesophageal RefluxNCT04166461
Mucosal Impedance Sleeve Gastrectomy
An observational study of Gastroesophageal Reflux and Bariatric Surgery Candidate, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Obesity is a growing epidemic and bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux, Bariatric Surgery Candidate
- What is being tested?
- Not application, observational study
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 15 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients from the Metrohealth Medical Center bariatric and weight management program who are candidates for sleeve gastrectomy.
Who may be able to join
- Ambulatory male or female (non-pregnant) and is 18-80 years old at the time of enrollment.
- Adults with BMI 35 ≥ kg/m2
- Patients scheduled for sleeve gastrectomy
- Patients with no presence of esophagitis on screening upper endoscopy will be recruited to pursue 6mo- post-op upper endoscopy.
Who cannot join
- Age < 18 or > 80 years old
- Female patients cannot be pregnant or agree to avoid pregnancy during study period.
- History of GERD, erosive esophagitis, esophageal stricture, Barrett's esophagus or esophageal varices
- History of a major motility disorder: achalasia, diffuse esophageal spasm, jackhammer esophagus, esophagogastric junction outflow obstruction, and absent peristalsis.
- History of Eosinophilic Esophagitis
- History of bariatric surgery or other upper gastrointestinal surgery
Show all 10Show fewer
- History of Scleroderma
- PPI use prior to bariatric procedure
- History of severe psychiatric disorder, including suicidal ideation or admission to psychiatric institution.
- Negative upper endoscopy during pre-LSG evaluation for esophagitis, Barrett's esophagus, peptic stricture or eosinophilic esophagitis.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MetroHealth - Main Campus Medical Center
Cleveland, Ohio, 44109
Ronnie Fass, MD, rfass@metrohealth.org
Neil Patel, MD, npatel15@metrohealth.org
About this study
Official title: Assessment of Esophageal Mucosal Impedance Before and After Sleeve Gastrectomy
Obesity is a growing epidemic and bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals. Studies have demonstrated that after LSG, between 5 and 30% of patients suffered from GERD, with a small subset of those patients (2.9 %) converting to another bariatric procedure (gastric bypass) because of debilitating GERD symptoms.
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure, as well as assess quality of life and GERD symptoms parameters. In addition, this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery. Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD.
Read more
This is a prospective, comparative cohort study. A total of 15 obese patients (BMI ≥ 35) undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program. An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation, during which mucosal impedance will be performed with the consent of the patient. Patients with evidence of erosive esophagitis (LA grade A-D), Barrett's esophagus or eosinophilic esophagitis will be excluded from the study. As per surgical recommendation, PPI will be used for 6 months in all bariatric patients.
Six months post-surgery, study patients will be re-evaluated by the GERD symptoms Checklist and SF 36. In addition, their new BMI will be documented. PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barrett's esophagus. In addition, esophageal mucosal impedance will be reassessed.
Read the detailed description
Rationale/Significance:
Obesity is a growing epidemic problem around the world. World Health Organization (WHO) defines obesity as a body mass index (BMI) over 30 Kg/m2 and it is estimated that 10% of the world's population is obese. Associated with obesity are health conditions that carry significant morbidity and mortality, including cardiovascular disease, osteoarthritis, diabetes, cancer (breast, colon and endometrial) and gastroesophageal reflux disease (GERD). Bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals.
As part of their limited GI workup, candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery. However, no studies are preferred to assess the degree of esophageal acid exposure in patients with normal endoscopy who are candidates for LSG. In addition, there is no routine assessment of patients post LSG for the development of GERD.
The effect of laparoscopic sleeve gastrectomy (LSG) on GERD has been equivocal with low-quality evidence suggesting both improvement and worsening of reflux after surgery. Studies have demonstrated that after LSG, between 5 and 30% of patients suffered from GERD, with a small subset of those patients (2.9 %) converting to another bariatric procedure (gastric bypass) because of debilitating GERD symptoms.
As part of their limited GI workup, candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery. Currently there is no routine formal (endoscopic or pH) assessment of patients after gastric weight loss surgery for the development of GERD. The effect of laparoscopic sleeve gastrectomy (LSG) on GERD has been equivocal with low-quality evidence from various studies suggesting both improvement and worsening of reflux after surgery.
The main purpose of this study is to evaluate whether GERD develops after LSG and to examine the esophagus after LSG for the possible development of acid reflux both endoscopically (visible by camera view) and on a cellular level by obtaining mucosal impedance. Mucosal impedance (MI) is a measurement that can evaluate if the structure of the esophageal tissue is normal or abnormal. MI is performed using an FDA approved endoscopic tool called "Mucosal Integrity Conductivity Test System" (Diversatek). The MI system software uses the collected data to determine if there is evidence of GERD.
Objective:
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure, as well as assess quality of life and GERD symptoms parameters. In addition, this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery. Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD.
This is a prospective, comparative cohort study. A total of 15 obese patients (BMI ≥ 35) undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program. An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation, during which mucosal impedance will be performed with the consent of the patient. Patients with evidence of erosive esophagitis (LA grade A-D), Barrett's esophagus or eosinophilic esophagitis will be excluded from the study. As per surgical recommendation, PPI will be used for 6 months in all bariatric patients.
Six months post-surgery, study patients will be re-evaluated by the GERD symptoms Checklist and SF 36. In addition, their new BMI will be documented. PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barrett's esophagus. In addition, esophageal mucosal impedance will be reassessed.
Primary aim
- To determine the development of GERD after sleeve gastrectomy by measuring esophageal mucosal impedance pre and post-surgery.
Secondary aim
- To determine the degree of GERD development post sleeve gastrectomy
- To determine any effect on quality of life post-sleeve gastrectomy
- Being tested
- Not application, observational study
- Keywords
- Mucosal impedance, Sleeve gastrectomy, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not application, observational studyOther
Not application, observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of gastroesophageal reflux disease after sleeve gastrectomy
On second esophagogastroduodenoscopy, visualized esophagitis would indicate development of gastroesophageal reflux disease.
Measured: Time of recruitment to 6 months after sleeve gastrectomy
Secondary outcomes (1)
Level of GERD and quality of life after sleeve gastrectomy
These measures would be obtained through surveys during follow up period.
Measured: Time of recruitment to 6 months after sleeve gastrectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start21 Apr 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RONNIE FASS, MetroHealth Medical Center
- Investigators
- Ronnie Fass, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166461
- Sponsor's protocol ID
- IRB19-00589
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Esophageal Mucosal Impedance Before and After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04166461
- Acronym / sponsor ID
- IRB19-00589
- Keywords
- Mucosal impedance, Sleeve gastrectomy, GERD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a growing epidemic and bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals. Studies have demonstrated that after LSG, between 5 and 30% of patients suffered from GERD, with a small subset of those patients (2.9 %) converting to another bariatric procedure (gastric bypass) because of debilitating GERD symptoms.
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure, as well as assess quality of life and GERD symptoms parameters. In addition, this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery. Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD.
This is a prospective, comparative cohort study. A total of 15 obese patients (BMI ≥ 35) undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program. An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation, during which mucosal impedance will be performed with the consent of the patient. Patients with evidence of erosive esophagitis (LA grade A-D), Barrett's esophagus or eosinophilic esophagitis will be excluded from the study. As per surgical recommendation, PPI will be used for 6 months in all bariatric patients.
Six months post-surgery, study patients will be re-evaluated by the GERD symptoms Checklist and SF 36. In addition, their new BMI will be documented. PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barrett's esophagus. In addition, esophageal mucosal impedance will be reassessed.
Detailed description
Rationale/Significance:
Obesity is a growing epidemic problem around the world. World Health Organization (WHO) defines obesity as a body mass index (BMI) over 30 Kg/m2 and it is estimated that 10% of the world's population is obese. Associated with obesity are health conditions that carry significant morbidity and mortality, including cardiovascular disease, osteoarthritis, diabetes, cancer (breast, colon and endometrial) and gastroesophageal reflux disease (GERD). Bariatric surgery has been shown to be the most effective and efficient mean of achieving significant and sustainable weight loss in morbidly obese individuals.
As part of their limited GI workup, candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery. However, no studies are preferred to assess the degree of esophageal acid exposure in patients with normal endoscopy who are candidates for LSG. In addition, there is no routine assessment of patients post LSG for the development of GERD.
The effect of laparoscopic sleeve gastrectomy (LSG) on GERD has been equivocal with low-quality evidence suggesting both improvement and worsening of reflux after surgery. Studies have demonstrated that after LSG, between 5 and 30% of patients suffered from GERD, with a small subset of those patients (2.9 %) converting to another bariatric procedure (gastric bypass) because of debilitating GERD symptoms.
As part of their limited GI workup, candidates for bariatric surgery usually undergo only an upper endoscopy prior to surgery. Currently there is no routine formal (endoscopic or pH) assessment of patients after gastric weight loss surgery for the development of GERD. The effect of laparoscopic sleeve gastrectomy (LSG) on GERD has been equivocal with low-quality evidence from various studies suggesting both improvement and worsening of reflux after surgery.
The main purpose of this study is to evaluate whether GERD develops after LSG and to examine the esophagus after LSG for the possible development of acid reflux both endoscopically (visible by camera view) and on a cellular level by obtaining mucosal impedance. Mucosal impedance (MI) is a measurement that can evaluate if the structure of the esophageal tissue is normal or abnormal. MI is performed using an FDA approved endoscopic tool called "Mucosal Integrity Conductivity Test System" (Diversatek). The MI system software uses the collected data to determine if there is evidence of GERD.
Objective:
The investigators propose this current study to examine mucosal impedance before and after sleeve gastrectomy using the novel mucosal impedance procedure, as well as assess quality of life and GERD symptoms parameters. In addition, this study will determine if the level of mucosal impedance pre-sleeve gastrectomy may predict the development of GERD post-surgery. Our Hypothesis is that sleeve gastrectomy is highly associated with the risk of developing new onset GERD.
This is a prospective, comparative cohort study. A total of 15 obese patients (BMI ≥ 35) undergoing sleeve gastrectomy by choice will be recruited into the study from our bariatric and weight management program. An initial screening upper endoscopy will be performed as part of pre-bariatric evaluation, during which mucosal impedance will be performed with the consent of the patient. Patients with evidence of erosive esophagitis (LA grade A-D), Barrett's esophagus or eosinophilic esophagitis will be excluded from the study. As per surgical recommendation, PPI will be used for 6 months in all bariatric patients.
Six months post-surgery, study patients will be re-evaluated by the GERD symptoms Checklist and SF 36. In addition, their new BMI will be documented. PPI will be held for at least 1 week and a 6 months post-surgical upper endoscopy will be performed to determine the presence or absence of erosive esophagitis and Barrett's esophagus. In addition, esophageal mucosal impedance will be reassessed.
Primary aim
- To determine the development of GERD after sleeve gastrectomy by measuring esophageal mucosal impedance pre and post-surgery.
Secondary aim
- To determine the degree of GERD development post sleeve gastrectomy
- To determine any effect on quality of life post-sleeve gastrectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients from the Metrohealth Medical Center bariatric and weight management program who are candidates for sleeve gastrectomy.
Key inclusion criteria (4 listed)
- Ambulatory male or female (non-pregnant) and is 18-80 years old at the time of enrollment.
- Adults with BMI 35 ≥ kg/m2
- Patients scheduled for sleeve gastrectomy
- Patients with no presence of esophagitis on screening upper endoscopy will be recruited to pursue 6mo- post-op upper endoscopy.
Key exclusion criteria (10 listed)
- Age < 18 or > 80 years old
- Female patients cannot be pregnant or agree to avoid pregnancy during study period.
- History of GERD, erosive esophagitis, esophageal stricture, Barrett's esophagus or esophageal varices
- History of a major motility disorder: achalasia, diffuse esophageal spasm, jackhammer esophagus, esophagogastric junction outflow obstruction, and absent peristalsis.
- History of Eosinophilic Esophagitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not application, observational studyNot application, observational study | Other | – |
Primary outcome
Development of gastroesophageal reflux disease after sleeve gastrectomy
Time frame: Time of recruitment to 6 months after sleeve gastrectomy
On second esophagogastroduodenoscopy, visualized esophagitis would indicate development of gastroesophageal reflux disease.
1 secondary outcome
Level of GERD and quality of life after sleeve gastrectomy
Time frame: Time of recruitment to 6 months after sleeve gastrectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronnie Fass, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux and Bariatric Surgery Candidate, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronnie Fass, MD (2167783145, rfass@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of gastroesophageal reflux disease after sleeve gastrectomy (time frame: Time of recruitment to 6 months after sleeve gastrectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.