Antireflux Mucosal AblationNCT07842354
Antireflux Mucosal Ablation vs Fundoplication for Refractory GERD
An observational study of Antireflux Mucosal Ablation and Laparoscopic Fundoplication Procedure, run by Minia University at 1 site in Egypt.
Trial summary
This study compared two treatments for patients with gastroesophageal reflux disease (GERD) that did not improve with standard acid-reducing medications. The two treatments were Antireflux Mucosal Ablation (ARMA), a newer endoscopic procedure, and laparoscopic Nissen fundoplication, a well-established surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure, Refractory GERD
- What is being tested?
- Modified Antireflux Mucosal Ablation (ARMA) and Laparoscopic Nissen Fundoplication
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of 200 adult patients with refractory gastroesophageal reflux disease (GERD) who were treated at two tertiary referral centers in Egypt between January 2023 and December 2024. One hundred patients underwent modified antireflux mucosal ablation (ARMA), and 100 patients underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team. All patients had persistent GERD symptoms despite optimized proton pump inhibitor (PPI) therapy and were eligible for either endoscopic or surgical intervention. Patients were identified from institutional databases and medical records, and all had complete follow-up data at 12 months.
Who may be able to join
- Adult patients aged 18 years or older
- Diagnosis of refractory gastroesophageal reflux disease (GERD) confirmed by 24-hour pH monitoring and/or endoscopy
- Persistent GERD symptoms despite at least 8 weeks of optimized proton pump inhibitor (PPI) therapy
- Incomplete symptom control or patient intolerance to PPI therapy
- Eligible for either endoscopic or surgical antireflux intervention based on multidisciplinary team assessment
- Ability to provide informed consent for retrospective review of medical records
- Complete medical records available for the study period (January 2023 to December 2024)
Who cannot join
- Age less than 18 years
- Prior antireflux surgery or endoscopic antireflux procedure
- Severe esophageal motility disorders (e.g., achalasia, diffuse esophageal spasm)
- Esophageal stricture or stenosis
- Hiatal hernia greater than 5 cm
- Barrett's esophagus with high-grade dysplasia or carcinoma
Show all 11Show fewer
- Active malignancy or life expectancy less than 12 months
- Contraindication to general anesthesia or laparoscopic surgery
- Pregnancy or breastfeeding
- Incomplete follow-up data at 12 months
- Patients who declined participation in the retrospective record review
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antireflux Mucosal Ablation Versus Laparoscopic Nissen Fundoplication for Refractory Gastroesophageal Reflux Disease: A Comparative Cohort Study of 200 Patients
This study compared two treatments for patients with gastroesophageal reflux disease (GERD) that did not improve with standard acid-reducing medications. The two treatments were Antireflux Mucosal Ablation (ARMA), a newer endoscopic procedure, and laparoscopic Nissen fundoplication, a well-established surgical procedure.
Two hundred patients with refractory GERD were enrolled between January 2023 and December 2024 at two tertiary referral centers in Egypt. One hundred patients underwent modified ARMA, and 100 patients underwent laparoscopic Nissen fundoplication. Treatment was determined by a multidisciplinary team according to a standardized protocol.
Read more
The study looked at quality of life scores related to GERD, whether patients were able to stop taking proton pump inhibitors (PPIs), and whether their DeMeester scores returned to normal at 12 months. It also examined surgical details, complications, recurrence rates, findings from routine endoscopy at 6 months, and overall treatment success.
This was a retrospective study, meaning the researchers reviewed existing medical records rather than assigning patients to treatments. The results may help doctors and patients choose the most appropriate treatment for refractory GERD.
Read the detailed description
Gastroesophageal reflux disease (GERD) that does not respond to proton pump inhibitor (PPI) therapy remains a significant clinical challenge. Laparoscopic Nissen fundoplication is the established surgical option for refractory GERD, but it carries risks of gas-bloat syndrome, dysphagia, and other complications. Antireflux mucosal ablation (ARMA) has emerged as a less invasive endoscopic alternative, but comparative data with fundoplication are limited.
This retrospective comparative cohort study enrolled 200 patients with refractory GERD between January 2023 and December 2024 at two tertiary referral centers in Egypt. One hundred patients underwent modified ARMA, and 100 patients underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team.
Primary outcomes included GERD-Health Related Quality of Life (GERD-HRQL) scores, PPI cessation rates, and DeMeester score normalization at 12 months. Secondary outcomes included operative parameters, complications, recurrence rates, routine re-endoscopy findings at 6 months, and treatment success rates.
Between-group differences were assessed using the chi-square test for proportions and the independent samples t-test or Mann-Whitney U test for continuous variables. This study aims to provide comparative evidence on the safety and effectiveness of ARMA versus laparoscopic Nissen fundoplication in patients with refractory GERD, potentially informing clinical decision-making and treatment selection.
- Conditions
- Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure, Refractory GERD, Endoscopic Therapy
- Being tested
- Modified Antireflux Mucosal Ablation (ARMA), 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.
Modified Antireflux Mucosal Ablation (ARMA)Procedure or surgery
Endoscopic antireflux mucosal ablation performed as a less invasive treatment for refractory gastroesophageal reflux disease. This procedure involves endoscopic ablation of the mucosa at the gastroesophageal junction to promote scarring and tightening, thereby reducing reflux.
Laparoscopic Nissen FundoplicationProcedure or surgery
Laparoscopic surgical fundoplication performed as the established surgical treatment for refractory gastroesophageal reflux disease. This procedure involves wrapping the gastric fundus around the lower esophagus to reinforce the antireflux barrier.
| Study group | Role | What they receive |
|---|---|---|
| Modified ARMA Group | One hundred patients with refractory GERD who underwent modified antireflux mucosal ablation (ARMA). Treatment allocation was protocol-driven and determined by a multidisciplinary team. Receives: Procedure: Modified Antireflux Mucosal Ablation (ARMA) | |
| Laparoscopic Nissen Fundoplication Group | One hundred patients with refractory GERD who underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team. Receives: Procedure: Laparoscopic Nissen Fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD-Health Related Quality of Life (GERD-HRQL) Score at 12 Months
Change in GERD-Health Related Quality of Life (GERD-HRQL) scores from baseline to 12 months after treatment. The GERD-HRQL is a validated questionnaire that assesses heartburn, regurgitation, and dysphagia symptoms and their impact on quality of life. Lower scores indicate better symptom control and improved quality of life.
Measured: Baseline and 12 months after treatment
Proton Pump Inhibitor (PPI) Cessation Rate at 12 Months
Proportion of patients who were able to completely discontinue proton pump inhibitor (PPI) therapy at 12 months after treatment. PPI cessation was defined as no regular use of PPI medications for at least 7 consecutive days prior to the 12-month assessment.
Measured: 12 months after treatment
DeMeester Score Normalization at 12 Months
Proportion of patients who achieved normalization of the DeMeester score at 12 months after treatment. The DeMeester score is derived from 24-hour pH monitoring and a score below 14.7 was considered normal. Normalization indicates adequate control of acid reflux.
Measured: 12 months after treatment
Secondary outcomes (11)
Operative duration
Duration of the surgical procedure.
Measured: During the procedure in Minutes
Estimated Blood Loss
Estimated volume of blood lost during the surgical procedure. Unit of Measure: Milliliters (mL)
Measured: During the procedure
Incidence of Intraoperative and Postoperative Complications
Incidence of patients who experienced any intraoperative or postoperative complication..." (e.g., bleeding, perforation, dysphagia, gas-bloat syndrome, need for reintervention).
- Unit of Measure: Percentage of participants (or "Number of participants")
Measured: From treatment until 12 months after treatment.
Complication Severity
Severity of complications classified according to the Clavien-Dindo classification system.
Measured: · Time Frame: From treatment until 12 months after treatment.
Length of Hospital Stay
Duration of hospitalization following the surgical procedure.
Measured: From Postoperative day 1 through 30 days after treatment.
Recurrence Rates
Proportion of patients who experienced recurrence of GERD symptoms or required reintroduction of PPI therapy or additional antireflux intervention after initial treatment success.
Measured: 12 months after treatment
Routine Re-Endoscopy Findings at 6 Months (Esophagitis Assessment)
Presence and severity of esophagitis as assessed by routine upper gastrointestinal endoscopy.
Measured: Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (Hiatal Hernia Assessment)
Presence and size of hiatal hernia as assessed by routine upper gastrointestinal endoscopy.
Measured: · Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (wrap Integrity)
Assessment of wrap integrity (for Nissen fundoplication) via routine upper gastrointestinal endoscopy. Unit of Measure: Number of participants
Measured: · Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (Mucosal Healing)
Assessment of mucosal healing (for ARMA) via routine upper gastrointestinal endoscopy.
- Unit of Measure: Number of participants.
Measured: Time Frame: 6 months after treatment.
Treatment Success Rate
Proportion of patients who achieved treatment success, defined as a composite endpoint of at least 50% improvement in GERD-HRQL score, PPI cessation, and no need for repeat antireflux intervention at 12 months.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antireflux Mucosal AblationStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Salah, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842354
- Sponsor's protocol ID
- 2043:07/2026
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antireflux Mucosal Ablation Versus Laparoscopic Nissen Fundoplication for Refractory Gastroesophageal Reflux Disease: A Comparative Cohort Study of 200 Patients
- ClinicalTrials.gov ID
- NCT07842354
- Acronym / sponsor ID
- 2043:07/2026
- Conditions
- Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure, Refractory GERD, Endoscopic Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 Sep 2026 (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.
This study compared two treatments for patients with gastroesophageal reflux disease (GERD) that did not improve with standard acid-reducing medications. The two treatments were Antireflux Mucosal Ablation (ARMA), a newer endoscopic procedure, and laparoscopic Nissen fundoplication, a well-established surgical procedure.
Two hundred patients with refractory GERD were enrolled between January 2023 and December 2024 at two tertiary referral centers in Egypt. One hundred patients underwent modified ARMA, and 100 patients underwent laparoscopic Nissen fundoplication. Treatment was determined by a multidisciplinary team according to a standardized protocol.
The study looked at quality of life scores related to GERD, whether patients were able to stop taking proton pump inhibitors (PPIs), and whether their DeMeester scores returned to normal at 12 months. It also examined surgical details, complications, recurrence rates, findings from routine endoscopy at 6 months, and overall treatment success.
This was a retrospective study, meaning the researchers reviewed existing medical records rather than assigning patients to treatments. The results may help doctors and patients choose the most appropriate treatment for refractory GERD.
Detailed description
Gastroesophageal reflux disease (GERD) that does not respond to proton pump inhibitor (PPI) therapy remains a significant clinical challenge. Laparoscopic Nissen fundoplication is the established surgical option for refractory GERD, but it carries risks of gas-bloat syndrome, dysphagia, and other complications. Antireflux mucosal ablation (ARMA) has emerged as a less invasive endoscopic alternative, but comparative data with fundoplication are limited.
This retrospective comparative cohort study enrolled 200 patients with refractory GERD between January 2023 and December 2024 at two tertiary referral centers in Egypt. One hundred patients underwent modified ARMA, and 100 patients underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team.
Primary outcomes included GERD-Health Related Quality of Life (GERD-HRQL) scores, PPI cessation rates, and DeMeester score normalization at 12 months. Secondary outcomes included operative parameters, complications, recurrence rates, routine re-endoscopy findings at 6 months, and treatment success rates.
Between-group differences were assessed using the chi-square test for proportions and the independent samples t-test or Mann-Whitney U test for continuous variables. This study aims to provide comparative evidence on the safety and effectiveness of ARMA versus laparoscopic Nissen fundoplication in patients with refractory GERD, potentially informing clinical decision-making and treatment selection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ARMA Group | – | Procedure: Modified Antireflux Mucosal Ablation (ARMA)One hundred patients with refractory GERD who underwent modified antireflux mucosal ablation (ARMA). Treatment allocation was protocol-driven and determined by a multidisciplinary team. |
| Laparoscopic Nissen Fundoplication Group | – | Procedure: Laparoscopic Nissen FundoplicationOne hundred patients with refractory GERD who underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of 200 adult patients with refractory gastroesophageal reflux disease (GERD) who were treated at two tertiary referral centers in Egypt between January 2023 and December 2024. One hundred patients underwent modified antireflux mucosal ablation (ARMA), and 100 patients underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team. All patients had persistent GERD symptoms despite optimized proton pump inhibitor (PPI) therapy and were eligible for either endoscopic or surgical intervention. Patients were identified from institutional databases and medical records, and all had complete follow-up data at 12 months.
Key inclusion criteria (7 listed)
- Adult patients aged 18 years or older
- Diagnosis of refractory gastroesophageal reflux disease (GERD) confirmed by 24-hour pH monitoring and/or endoscopy
- Persistent GERD symptoms despite at least 8 weeks of optimized proton pump inhibitor (PPI) therapy
- Incomplete symptom control or patient intolerance to PPI therapy
- Eligible for either endoscopic or surgical antireflux intervention based on multidisciplinary team assessment
Key exclusion criteria (11 listed)
- Age less than 18 years
- Prior antireflux surgery or endoscopic antireflux procedure
- Severe esophageal motility disorders (e.g., achalasia, diffuse esophageal spasm)
- Esophageal stricture or stenosis
- Hiatal hernia greater than 5 cm
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 |
|---|---|---|
| Modified Antireflux Mucosal Ablation (ARMA)Endoscopic antireflux mucosal ablation performed as a less invasive treatment for refractory gastroesophageal reflux disease. This procedure involves endoscopic ablation of the mucosa at the gastroesophageal junction to promote scarring and tightening, thereby reducing reflux. | Procedure or surgery | Modified ARMA Group |
| Laparoscopic Nissen FundoplicationLaparoscopic surgical fundoplication performed as the established surgical treatment for refractory gastroesophageal reflux disease. This procedure involves wrapping the gastric fundus around the lower esophagus to reinforce the antireflux barrier. | Procedure or surgery | Laparoscopic Nissen Fundoplication Group |
Primary outcome
GERD-Health Related Quality of Life (GERD-HRQL) Score at 12 Months
Time frame: Baseline and 12 months after treatment
Change in GERD-Health Related Quality of Life (GERD-HRQL) scores from baseline to 12 months after treatment. The GERD-HRQL is a validated questionnaire that assesses heartburn, regurgitation, and dysphagia symptoms and their impact on quality of life. Lower scores indicate better symptom control and improved quality of life.
Proton Pump Inhibitor (PPI) Cessation Rate at 12 Months
Time frame: 12 months after treatment
Proportion of patients who were able to completely discontinue proton pump inhibitor (PPI) therapy at 12 months after treatment. PPI cessation was defined as no regular use of PPI medications for at least 7 consecutive days prior to the 12-month assessment.
DeMeester Score Normalization at 12 Months
Time frame: 12 months after treatment
Proportion of patients who achieved normalization of the DeMeester score at 12 months after treatment. The DeMeester score is derived from 24-hour pH monitoring and a score below 14.7 was considered normal. Normalization indicates adequate control of acid reflux.
11 secondary outcomes
Operative duration
Time frame: During the procedure in Minutes
Estimated Blood Loss
Time frame: During the procedure
Incidence of Intraoperative and Postoperative Complications
Time frame: From treatment until 12 months after treatment.
Complication Severity
Time frame: · Time Frame: From treatment until 12 months after treatment.
Length of Hospital Stay
Time frame: From Postoperative day 1 through 30 days after treatment.
Recurrence Rates
Time frame: 12 months after treatment
Routine Re-Endoscopy Findings at 6 Months (Esophagitis Assessment)
Time frame: Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (Hiatal Hernia Assessment)
Time frame: · Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (wrap Integrity)
Time frame: · Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (Mucosal Healing)
Time frame: Time Frame: 6 months after treatment.
Treatment Success Rate
Time frame: 12 months after treatment
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 25 Sep 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Antireflux Mucosal Ablation and Laparoscopic Fundoplication Procedure, run by Minia University at 1 site in Egypt.
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 7 inclusion and 11 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 25 Sep 2026. 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 Egypt. 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-Health Related Quality of Life (GERD-HRQL) Score at 12 Months (time frame: Baseline and 12 months after treatment). 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 25 Sep 2026.