GERDGERDNCT02142998
A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring
A study testing 24 pH monitoring and Esophageal Manometry: in people with GERD, run by McMaster University at 1 site in Canada.
Trial summary
Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- 24 pH monitoring and Esophageal Manometry:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Dec 2018
- 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
- Fulfilled criteria for bariatric surgery as coined by National Institutes of Health conference.
- Their age is ≥18 years and ≤70 years
- The group with symptoms of GERD needs to have diagnosis of GERD in their medical record and taking proton pump inhibitors on a daily basis.
- Able and willing to give written consent
- The patient is willing to perform the pre-operative tests required for this study.
- The patient fits for both surgeries - LSG or LRYGB
Who cannot join
- Previous bariatric surgery
- Previous anti reflux procedure
- Contra-indication to general anesthesia
- Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
- Hiatal hernia above 4cm (measured in the pre-operative gastroscopy).
- Multiple surgeries in abdominal cavity or previous small bowel disease/resection
- Patient on CPAP treatment for his OSA disease
Trial locations and contacts
1 site in 1 country.
About this study
Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. In the last few years LSG has gained in popularity due to its simplicity and short operative time. Currently the comparison between bariatric surgery and GERD symptoms is very one sided. There are significant numbers of studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms, however there is little evidence that states the same about LSG. This means that the relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up time points will contribute greatly to our understanding of what this relationship might be.
- Conditions
- GERD
- Being tested
- 24 pH monitoring, Esophageal Manometry:
- Keywords
- GERD, Laparoscopic, sleeve, gastrectomy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 pH monitoringOther
The study is performed with the patient fasting for a minimum of 6 hours. A single channel or dual channel (15 cm spacing) pH probe is inserted trans nasally. The pH sensor, or distal pH sensor in the case of 2 channel testing, is positioned 5 cm above the proximal margin of the LES, as determined by esophageal manometric testing. pH-Z ambulatory monitor (Given Imaging Digitrapper) is used for data acquisition and the data analyzed with pH Analysis Program (Given Imaging AccuView). The number of reflux events, defined as a drop in esophageal pH readings below 4.0, is recorded and the percentage of time with esophageal acid exposure is analyzed using defined protocols and accepted normal values.
Esophageal Manometry:Other
A high resolution esophageal manometry catheter is used for testing and inserted Trans nasally. The patient is given 10 liquid swallows (5mL of water), at intervals of approximately 30 seconds. The catheter (Sierra Scientific/Given Imaging) has 36 sensors, each one averaging pressures from 12 circumferential positions. This gives a total of 432 data points. The sensors are placed 1 cm apart, spanning a length of 35 cm. The catheter simultaneously records pressure readings from the esophagus, sphincter regions (UES and LES), pharynx and stomach without the need for a station pull-through technique. Results are reported according to defined protocols and accepted normal values.
| Study group | Role | What they receive |
|---|---|---|
| GERD Symptoms | Active comparator | Not described Receives: Other: 24 pH monitoring; Other: Esophageal Manometry: |
| No GERD Symptoms | Active comparator | Not described Receives: Other: 24 pH monitoring; Other: Esophageal Manometry: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observe acid exposure to the distal esophagus
This will be measured using the esophageal 24 hours monitoring before surgery and at the 6 month follow up. The patients will be randomized to two different types of surgery and the results compared.
Measured: 1 year
Secondary outcomes (1)
Compare GERD symptoms in patients.
This will be measured using esophageal manometry prior to surgery and at the six month follow up visit. We are looking for time in minutes with a pH of below 4 and a Demeeser score of below 14.7
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: On hold due to poor enrollment and high drop-out rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehran Anvari, McMaster University
- Investigators
- Mehran Anvari, MB BS, PhD, Principal investigator, Centre for Minimal Access Surgery, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142998
- Sponsor's protocol ID
- 14-001
- Acronym
- GERD
- Status last verified
- Apr 2017
- First submitted
- 24 Mar 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring
- ClinicalTrials.gov ID
- NCT02142998
- Acronym / sponsor ID
- GERD / 14-001
- Conditions
- GERD
- Keywords
- GERD, Laparoscopic, sleeve, gastrectomy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: On hold due to poor enrollment and high drop-out rate.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 May 2014 (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.
Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. In the last few years LSG has gained in popularity due to its simplicity and short operative time. Currently the comparison between bariatric surgery and GERD symptoms is very one sided. There are significant numbers of studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms, however there is little evidence that states the same about LSG. This means that the relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up time points will contribute greatly to our understanding of what this relationship might be.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERD Symptoms | Active comparator | Other: 24 pH monitoring, Other: Esophageal Manometry: |
| No GERD Symptoms | Active comparator | Other: 24 pH monitoring, Other: Esophageal Manometry: |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fulfilled criteria for bariatric surgery as coined by National Institutes of Health conference.
- Their age is ≥18 years and ≤70 years
- The group with symptoms of GERD needs to have diagnosis of GERD in their medical record and taking proton pump inhibitors on a daily basis.
- Able and willing to give written consent
- The patient is willing to perform the pre-operative tests required for this study.
Key exclusion criteria (8 listed)
- Previous bariatric surgery
- Previous anti reflux procedure
- Contra-indication to general anesthesia
- Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
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 |
|---|---|---|
| 24 pH monitoringThe study is performed with the patient fasting for a minimum of 6 hours. A single channel or dual channel (15 cm spacing) pH probe is inserted trans nasally. The pH sensor, or distal pH sensor in the case of 2 channel testing, is positioned 5 cm above the proximal margin of the LES, as determined by esophageal manometric testing. pH-Z ambulatory monitor (Given Imaging Digitrapper) is used for data acquisition and the data analyzed with pH Analysis Program (Given Imaging AccuView). The number of reflux events, defined as a drop in esophageal pH readings below 4.0, is recorded and the percentage of time with esophageal acid exposure is analyzed using defined protocols and accepted normal values. | Other | GERD Symptoms, No GERD Symptoms |
| Esophageal Manometry:A high resolution esophageal manometry catheter is used for testing and inserted Trans nasally. The patient is given 10 liquid swallows (5mL of water), at intervals of approximately 30 seconds. The catheter (Sierra Scientific/Given Imaging) has 36 sensors, each one averaging pressures from 12 circumferential positions. This gives a total of 432 data points. The sensors are placed 1 cm apart, spanning a length of 35 cm. The catheter simultaneously records pressure readings from the esophagus, sphincter regions (UES and LES), pharynx and stomach without the need for a station pull-through technique. Results are reported according to defined protocols and accepted normal values. | Other | GERD Symptoms, No GERD Symptoms |
Primary outcome
Observe acid exposure to the distal esophagus
Time frame: 1 year
This will be measured using the esophageal 24 hours monitoring before surgery and at the 6 month follow up. The patients will be randomized to two different types of surgery and the results compared.
1 secondary outcome
Compare GERD symptoms in patients.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
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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
Centre for Minimal Access Surgery, 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 24 pH monitoring and Esophageal Manometry: in people with GERD, 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 6 inclusion and 8 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: paused, as of the sponsor's last update on 26 Apr 2017. 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?
Results are not available in the source record.
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?
Observe acid exposure to the distal esophagus (time frame: 1 year). 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 26 Apr 2017.