GastroEsophageal Reflux DiseaseSTAR RegistryNCT02211105
Registry to Compare Two Surgical Treatments for GERD
An observational study of GastroEsophageal Reflux Disease, run by American Gastroenterological Association at 10 sites in United States.
Trial summary
The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GastroEsophageal Reflux Disease
- How many people
- 46 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2014to Apr 2017
- How long will I take part?
- 3 Years
- 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: Adults who meet clinical criteria and have decided to treat their GERD through one of two surgical procedures, (LNF or TIF) and agree to have their standard GI medical data for 3 years.
Who may be able to join
- GERD symptoms (heartburn, defined by a sub-sternal burning discomfort arising from the upper abdomen into the chest, and or regurgitation, defined as the effortless arising of liquid material into the chest or mouth) two or more times a week (when not on anti-secretory medication) that adversely affects the patient's quality of life. Additionally, patients will have to have responded to medical therapy (adequate relief of symptoms) as indicated by GERD-HRQL and regurgitation scores on medical therapy. In this context, scores ≤ 2 on each GERD-HRQL and regurgitation question (while on medication) indicate absence of daily bothersome symptoms and therefore these patients are considered responsive to medical therapy. Furthermore, patients will have to have objective evidence of GERD documented (esophagitis on endoscopy or pathological intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring).
- Age 18-80 years
- Ability to give informed consent
- Regular access to a telephone
- Meet the clinical criteria for treatment of GERD with TIF or LNF and undergo TIF or LNF within 90 days of providing consent.
- Dependent upon PPIs for control of heartburn for > six months or patient determined to have an inadequate response of regurgitation symptoms despite heartburn control with PPIs
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- Hiatal hernia axial length is no larger than 2 cm and the transverse dimension should not exceed 2.0 cm
- Gastroesophageal junction with a Hill Grade I-II
- --- Patient willing to provide informed consent, cooperate with post-operative dietary recommendations and follow-up assessment tests
- Objective documentation of pathological acid-reflux by either a) increased intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring (pH<4 for 4.5% or greater of the time) with or without impedance b) or the presence of erosive esophagitis (LA Grade A or B) on endoscopy
- Absence of a severe esophageal motility disorder (note: mild abnormalities in esophageal motility are common in GERD such as small breaks, etc.) including achalasia, esophagogastric junction outflow obstruction, frequent failed peristalsis, diffuse esophageal spasm, nutcracker or jackhammer esophagus etc. on high-resolution esophageal manometry using the Chicago classification system or evidence of incomplete bolus clearance on 30% or more of swallows by impedance testing.
Who cannot join
- Hiatal hernia > 2 cm (defined as longitudinal length measured endoscopically between the proximal margin of the gastric folds and the diaphragmatic pinch)
- Esophagitis LA Grade C or D
- Presence of troublesome atypical symptoms
- Barrett's esophagus greater than 2 cm in length or with any dysplasia
- Esophageal stricture or severe esophageal motility disorder
- History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, cirrhosis or any other uncontrolled systemic disease
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- --. Active gastro-duodenal ulcer disease
- Gastric outlet obstruction or stenosis
- Gastroparesis or delayed gastric emptying confirmed by a four hour solid-phase gastric emptying study
- Body Mass Index (BMI) > 35
- Pregnancy or plans for pregnancy within 12 months of the procedure
- Portal hypertension and/or varices
- New York Heart Association classification of III or IV.
- Coagulation disorders
- Intraprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe performance of the procedure
- Enrollment in another device or drug study that may confound result
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Texas at Houston
Bellaire, Texas, 77401
GI Solutions Inc
Chicago, Illinois
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Texas Tech University Health Sciences Center
El Paso, Texas, 79912
SurgOne Foregut Institute
Englewood, Colorado, 80110
NorthShore University HealthSystem
Evanston, Illinois, 60201
OC Reflux
Huntington Beach, California
Lenox Hill Hospital
New York, New York, 10011
Oregon Health & Science University
Portland, Oregon, 97239-3098
Reston Hospital Center/ GW University
Reston, Virginia, 20190
About this study
Official title: Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti- Reflux Treatment Registry
The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications.
Read the detailed description
This registry will prospectively enroll 500 patients undergoing TIF and LNF from approximately 20 United States centers proficient in these procedures that have provided informed consent for the above mentioned data collection (symptom questionnaires, medical treatments, complications, side-effects and costs). The observational registry will obtain the patients clinical data related to gastrointestinal symptoms for three years post-consent.
At baseline and for a three-year period following a clinically indicated TIF or LNF procedure, data will be obtained from phone calls and/or during office-visits made at specified intervals. During these data collection periods, patients will be asked to complete standard validated symptom questionnaires as well as report on episodes of care related to their procedures along with financial costs of care.
- Conditions
- GastroEsophageal Reflux Disease
- Keywords
- GastroEsophageal Reflux Disease, Transoral Incisionless Fundoplication, 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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Nissen Fundoplication | Patients whose GERD is being treated surgically through Laparoscopic Nissen Fundoplication. | |
| Transoral Incisionless Fundoplication | Patients whose GERD is being treated surgically through Transoral Incisionless Fundoplication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness as measured by a 75% reduction in GERD HRQL)
To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.
Measured: 3 years
Secondary outcomes (1)
Effectiveness using a 50% reduction in GERD-HRQL
Compare effectiveness using a 50% reduction in GERD-HRQL as a threshold for effectiveness of TIF and LNF at the end of three years compared to baseline.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Unexpected low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroEsophageal Reflux DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- American Gastroenterological Association
- Sponsor type
- University, hospital or other
- Collaborators
- EndoGastric Solutions
- Responsible party
- Sponsor
- Investigators
- M. Brian Fennerty, M.D., Principal investigator, Oregon Health and Science UniversityW. Scott Melvin, M.D., Principal investigator, Montefiore Medical CenterAshish Atreja, M.D., Study chair, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211105
- Sponsor's protocol ID
- AGA STAR Registry
- Acronym
- STAR Registry
- Status last verified
- Apr 2017
- First submitted
- 5 Aug 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti- Reflux Treatment Registry
- ClinicalTrials.gov ID
- NCT02211105
- Acronym / sponsor ID
- STAR Registry / AGA STAR Registry
- Conditions
- GastroEsophageal Reflux Disease
- Keywords
- GastroEsophageal Reflux Disease, Transoral Incisionless Fundoplication, Laparoscopic Nissen Fundoplication
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unexpected low accrual
- Enrolment
- 46 participants (actual)
- Lead sponsor
- American Gastroenterological AssociationUniversity, hospital or other
- Collaborators
- EndoGastric Solutions
- Study start
- Jul 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Aug 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.
The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications.
Detailed description
This registry will prospectively enroll 500 patients undergoing TIF and LNF from approximately 20 United States centers proficient in these procedures that have provided informed consent for the above mentioned data collection (symptom questionnaires, medical treatments, complications, side-effects and costs). The observational registry will obtain the patients clinical data related to gastrointestinal symptoms for three years post-consent.
At baseline and for a three-year period following a clinically indicated TIF or LNF procedure, data will be obtained from phone calls and/or during office-visits made at specified intervals. During these data collection periods, patients will be asked to complete standard validated symptom questionnaires as well as report on episodes of care related to their procedures along with financial costs of care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Nissen Fundoplication | – | –Patients whose GERD is being treated surgically through Laparoscopic Nissen Fundoplication. |
| Transoral Incisionless Fundoplication | – | –Patients whose GERD is being treated surgically through Transoral Incisionless Fundoplication. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who meet clinical criteria and have decided to treat their GERD through one of two surgical procedures, (LNF or TIF) and agree to have their standard GI medical data for 3 years.
Key inclusion criteria (11 listed)
- GERD symptoms (heartburn, defined by a sub-sternal burning discomfort arising from the upper abdomen into the chest, and or regurgitation, defined as the effortless arising of liquid material into the chest or mouth) two or more times a week (when not on anti-secretory medication) that adversely affects the patient's quality of life. Additionally, patients will have to have responded to medical therapy (adequate relief of symptoms) as indicated by GERD-HRQL and regurgitation scores on medical therapy. In this context, scores ≤ 2 on each GERD-HRQL and regurgitation question (while on medication) indicate absence of daily bothersome symptoms and therefore these patients are considered responsive to medical therapy. Furthermore, patients will have to have objective evidence of GERD documented (esophagitis on endoscopy or pathological intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring).
- Age 18-80 years
- Ability to give informed consent
- Regular access to a telephone
- Meet the clinical criteria for treatment of GERD with TIF or LNF and undergo TIF or LNF within 90 days of providing consent.
Key exclusion criteria (16 listed)
- Hiatal hernia > 2 cm (defined as longitudinal length measured endoscopically between the proximal margin of the gastric folds and the diaphragmatic pinch)
- Esophagitis LA Grade C or D
- Presence of troublesome atypical symptoms
- Barrett's esophagus greater than 2 cm in length or with any dysplasia
- Esophageal stricture or severe esophageal motility disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness as measured by a 75% reduction in GERD HRQL)
Time frame: 3 years
To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.
1 secondary outcome
Effectiveness using a 50% reduction in GERD-HRQL
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Unexpected low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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.
M. Brian Fennerty, M.D. principal investigator
Oregon Health and Science University
W. Scott Melvin, M.D. principal investigator
Montefiore Medical Center
Ashish Atreja, M.D. study chair
MOUNT SINAI HOSPITAL
10 sites 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 Disease, run by American Gastroenterological Association at 10 sites 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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study was stopped early (reason given: Unexpected low accrual). 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?
Effectiveness as measured by a 75% reduction in GERD HRQL) (time frame: 3 years). 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 9 Jan 2018.