Gastroesophageal RefluxNCT00182260
A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication Treatment of Patients With Chronic GERD
A study testing Proton Pump Inhibitors and Laparoscopic Nissen Fundoplication in people with Gastroesophageal Reflux, run by McMaster University at 1 site in Canada.
Trial summary
LNF is an effective intervention in the management of patients with chronic GERD requiring maintenance therapy. LNF is cost-effective compared with long-term medical therapy. LNF is more effective than maximum medical therapy in control of respiratory symptoms and complications of GERD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Proton Pump Inhibitors and Laparoscopic Nissen Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2000to Apr 2010
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female GERD patients aged 18-70 years with GERD symptoms.
- Prior long-term treatment with PPI with minimum duration of 1 year with expected future duration of at least 2 more years.
- Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD symptom score<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on medication).
- Increase in GERD symptom score>=15 points at baseline (off omeprazole).
- GERD symptom score>=18 at baseline (off omeprazole).
- Percent acid reflux in 24hr 4% at baseline (off omeprazole).
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- Positive Bernstein test at baseline.
- Willingness to adhere to randomized treatment with availability for 3 years of follow-up.
- Ability to answer self and interviewer-administered questions in English.
- Signed informed consent.
Who cannot join
- Aperistaltic esophagus.
- Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable surgical risk in the investigator's opinion.
- Previous gastric, esophageal or anti-reflux surgery.
- History of malignancy within the last year with the exception of basal cell carcinoma.
- Pregnancy or an intention to become pregnant in the following year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ELVIS (Esophagitis-Laparoscopy Versus Inhibitors of Secretion) A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication (LNF) Versus Omeprazole for Treatment of Patients With Chronic Gastro-Esophageal Reflux Disease (GERD)
LNF is an effective intervention in the management of patients with chronic GERD requiring maintenance therapy. LNF is cost-effective compared with long-term medical therapy.
LNF is more effective than maximum medical therapy in control of respiratory symptoms and complications of GERD.
Read the detailed description
GERD encompasses a variety of symptoms and pathological findings caused by the reflux of gastric contents into the esophagus although symptoms and pathology may occur independently of each other. GERD usually presents with typical symptoms of retrosternal burning (heartburn) with or without chest pain and regurgitation of gastric contents into the back of the mouth. However, symptoms often occur in the absence of abnormalities associated with GERD, such as esophageal erosions, ulceration, stricturing or Barrett's esophagus. There is no clear correlation between symptoms and the histological features of GERD. Less prevalent manifestations of GERD include the geneses of dental erosions and respiratory disease including aspiration pneumonia, asthma, chronic laryngitis. Most often, GERD is due to excessive reflux of gastric contents into the esophagus rather than gastric acid hypersecretion. Reflux is caused by an increase in the frequency of inappropriate transient relaxations of the lower esophageal sphincter (LES). In most patients, basal resting LES pressure is normal although LES hypotonia, reduced esophageal body contractility and the presence of a hiatus hernia may exacerbate reflux or reduce esophageal clearance. Impaired esophageal mucosal resistance can increase the potential for esophageal damage. Bile acids and pancreatic enzymes have been implicated in the pathogenesis of GERD but it is generally accepted that the major causes of esophageal symptoms and injury are gastric acid and pepsin, which are active only at low ambient pH. Severity of esophagitis and of reflux symptoms correlate well with the duration of esophageal acid exposure with clear correlation between acid secretory inhibition and esophagitis healing rates for any given drug. On this basis, treatment for GERD has been directed towards:
Minimization of potential precipitating factors by lifestyle modifications such as weight loss, small meals and, avoidance of alcohol and tobacco.
Improving LES pressure, esophageal clearance and gastric emptying, using prokinetic agents.
Neutralization of acid in the stomach or esophagus, using antacids. Reduction of acid secretion, using histamine receptor antagonists(H2RAs) or PPI's.
Surgical prevention of gastro-esophageal reflux by fundoplication. In practice, the latter two approaches are the most successful for patients with more severe GERD and PPI's have proven more efficacious than H2RAs.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Proton Pump Inhibitors, Laparoscopic Nissen Fundoplication
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Pump InhibitorsDrug
Laparoscopic Nissen FundoplicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Proton Pump Inhibitor | Active comparator | Patients randomized to medical therapy received optimized treatment with PPI using a standardized management protocol based on best evidence and published guidelines. Receives: Drug: Proton Pump Inhibitors |
| Laparoscopic Nissen Fundoplication | Active comparator | Surgical patients underwent LNF using previously published technique. Receives: Procedure: Laparoscopic Nissen Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD Symptom Scale
Symptom-free Day Measurement
Cost Measurement
Secondary outcomes (7)
24-hour pH
Economic Analysis
Endoscopy
Esophageal manometry
Health related quality of life (SF-36)
Health Utility Index
Respiratory function, airways hypersensitivity and inflammation and microaspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2000
- Primary completionApr 2010
- Study completionApr 2010
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.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Mehran Anvari, McMaster University
- Investigators
- Mehran Anvari, MB, BS, PhD, Principal investigator, McMaster UniversityDavid Armstrong, MB, BCh, MA, Principal investigator, McMaster UniversityCharles H. Goldsmith, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182260
- Sponsor's protocol ID
- CIHR-MCT-38147
- Other IDs
- MOH Grant 05276
- Status last verified
- Nov 2012
- First submitted
- 12 Sep 2005
- Last updated
- 15 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELVIS (Esophagitis-Laparoscopy Versus Inhibitors of Secretion) A Randomized Controlled Trial of Laparoscopic Nissen Fundoplication (LNF) Versus Omeprazole for Treatment of Patients With Chronic Gastro-Esophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00182260
- Acronym / sponsor ID
- CIHR-MCT-38147
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Jan 2000
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- 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.
LNF is an effective intervention in the management of patients with chronic GERD requiring maintenance therapy. LNF is cost-effective compared with long-term medical therapy.
LNF is more effective than maximum medical therapy in control of respiratory symptoms and complications of GERD.
Detailed description
GERD encompasses a variety of symptoms and pathological findings caused by the reflux of gastric contents into the esophagus although symptoms and pathology may occur independently of each other. GERD usually presents with typical symptoms of retrosternal burning (heartburn) with or without chest pain and regurgitation of gastric contents into the back of the mouth. However, symptoms often occur in the absence of abnormalities associated with GERD, such as esophageal erosions, ulceration, stricturing or Barrett's esophagus. There is no clear correlation between symptoms and the histological features of GERD. Less prevalent manifestations of GERD include the geneses of dental erosions and respiratory disease including aspiration pneumonia, asthma, chronic laryngitis. Most often, GERD is due to excessive reflux of gastric contents into the esophagus rather than gastric acid hypersecretion. Reflux is caused by an increase in the frequency of inappropriate transient relaxations of the lower esophageal sphincter (LES). In most patients, basal resting LES pressure is normal although LES hypotonia, reduced esophageal body contractility and the presence of a hiatus hernia may exacerbate reflux or reduce esophageal clearance. Impaired esophageal mucosal resistance can increase the potential for esophageal damage. Bile acids and pancreatic enzymes have been implicated in the pathogenesis of GERD but it is generally accepted that the major causes of esophageal symptoms and injury are gastric acid and pepsin, which are active only at low ambient pH. Severity of esophagitis and of reflux symptoms correlate well with the duration of esophageal acid exposure with clear correlation between acid secretory inhibition and esophagitis healing rates for any given drug. On this basis, treatment for GERD has been directed towards:
Minimization of potential precipitating factors by lifestyle modifications such as weight loss, small meals and, avoidance of alcohol and tobacco.
Improving LES pressure, esophageal clearance and gastric emptying, using prokinetic agents.
Neutralization of acid in the stomach or esophagus, using antacids. Reduction of acid secretion, using histamine receptor antagonists(H2RAs) or PPI's.
Surgical prevention of gastro-esophageal reflux by fundoplication. In practice, the latter two approaches are the most successful for patients with more severe GERD and PPI's have proven more efficacious than H2RAs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Pump Inhibitor | Active comparator | Drug: Proton Pump InhibitorsPatients randomized to medical therapy received optimized treatment with PPI using a standardized management protocol based on best evidence and published guidelines. |
| Laparoscopic Nissen Fundoplication | Active comparator | Procedure: Laparoscopic Nissen FundoplicationSurgical patients underwent LNF using previously published technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female GERD patients aged 18-70 years with GERD symptoms.
- Prior long-term treatment with PPI with minimum duration of 1 year with expected future duration of at least 2 more years.
- Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD symptom score<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on medication).
- Increase in GERD symptom score>=15 points at baseline (off omeprazole).
- GERD symptom score>=18 at baseline (off omeprazole).
Key exclusion criteria (5 listed)
- Aperistaltic esophagus.
- Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable surgical risk in the investigator's opinion.
- Previous gastric, esophageal or anti-reflux surgery.
- History of malignancy within the last year with the exception of basal cell carcinoma.
- Pregnancy or an intention to become pregnant in the following year.
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 |
|---|---|---|
| Proton Pump Inhibitors | Drug | Proton Pump Inhibitor |
| Laparoscopic Nissen Fundoplication | Procedure or surgery | Laparoscopic Nissen Fundoplication |
Primary outcome
GERD Symptom Scale
Symptom-free Day Measurement
Cost Measurement
7 secondary outcomes
24-hour pH
Economic Analysis
Endoscopy
Esophageal manometry
Health related quality of life (SF-36)
Health Utility Index
Respiratory function, airways hypersensitivity and inflammation and microaspiration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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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.
Mehran Anvari, MB, BS, PhD principal investigator
McMaster University
David Armstrong, MB, BCh, MA principal investigator
McMaster University
Charles H. Goldsmith, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Pump Inhibitors and Laparoscopic Nissen Fundoplication in people with Gastroesophageal Reflux, run by McMaster University at 1 site in Canada.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 15 Nov 2012. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD Symptom Scale. The study lists 3 primary outcomes in all. 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 15 Nov 2012.