Gastroesophageal Reflux DiseaseARMVNCT06348420
Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
A study testing anti-reflux mucosal valvuloplasty (ARMV) in people with Gastroesophageal Reflux Disease, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- anti-reflux mucosal valvuloplasty (ARMV)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age;
- Hiatal hernia ≤ 2 cm;
- Sliding hernia ≤ 2 cm;
- Recurrence of GERD symptoms after cessation of PPIs;
- On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
- Esophagitis (Los Angeles Classification) Grade B, C, or D;
Show all 12Show fewer
- Hill's flap valve grade ≤ III;
- Observation of distal esophageal pH < 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;
- Normal or near-normal esophageal motility;
- Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;
- DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;
- Completion of a signed informed consent form.
Who cannot join
- BMI > 35 kg/m2;
- ASA > II;
- Barrett's esophagus;
- Hiatal hernia > 2 cm;
- Esophagitis (Los Angeles Classification) Grade A or No esophagitis；
- Hill's flap valve grade > III；
Show all 13Show fewer
- Peptic ulcer disease;
- Primary esophageal motility disorders such as achalasia;
- Severe gastroparesis;
- History of previous esophageal or gastric surgery, including ARMS or ARMA;
- Uncontrolled systemic diseases;
- Gastric outlet obstruction;
- Pregnancy or planning to become pregnant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center
Jinan, Shandong, 250000
xiaofen lv, 15670188361, lxf202215602@163.com
About this study
Official title: Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial
The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
Read the detailed description
Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV.
During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.
After the ARMV procedure, PPI therapy is continued for 1 month to promote mucosal healing before being discontinued. If symptoms reoccur, the PPI management regimen is reinstated for the ARMV group, with diligent recording of PPI usage in a medication diary.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- anti-reflux mucosal valvuloplasty (ARMV)
- Keywords
- Endoscopic anti-reflux, Proton pump inhibitor, Randomized controlled trial, Gastroesophageal reflux disease
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-reflux mucosal valvuloplasty (ARMV)Procedure or surgery
During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.
| Study group | Role | What they receive |
|---|---|---|
| ARMV (intervention group) | Experimental | Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV. Receives: Procedure: anti-reflux mucosal valvuloplasty (ARMV) |
| PPI (control group) | No intervention | Patients randomized to the PPI group will follow the PPI treatment scheme. If GERD symptoms are effectively controlled with their current PPI dosage for at least one month, the regimen is decreased by one step. Conversely, if symptoms are poorly controlled, the dosage is increased by one step based on the PPI algorithm, which aligns with best clinical practices. The use of PPI will be recorded in medication diaries using generic names listed in the table below and classified according to the daily dose and frequency. Dosage will be categorized as "double dose" = ≥30 or 40 mg per day, "full dose" = 30 or 40 mg per day, "half dose" = 15 or 20 mg per day, "occasional" or "on demand" = < "full dose" taken for < 50% of days in the follow-up period. Common medications include Nexium 20mg、Prevacid 30mg、Prilosec 20mg、Protonix 20mg、Aciphex20mg.The frequency of medication use is once a day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD-HRQL
Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores to questions 1-15 Greatest possible score (worst symptoms)= 75 Lowest possible score (no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
Measured: at 0, 6 months follow- up
Secondary outcomes (6)
GERD-Q score
Questionnaire (GERD-Q ) : Recall the frequency of burning sensation (heartburn) after your sternum in the past 7 days;How often do you feel stomach contents (liquid or food) returning to your throat or mouth (reflux) in the past 7 days?How often did you feel pain in the center of your upper abdomen in the past 7 days?How often did you feel nauseous in the past 7 days?How often have you had difficulty getting good night sleep due to heartburn and/or reflux in the past 7 days? Looking back on the past 7 days, in addition to the medication advised by the doctor, did you take additional medication to alleviate the frequency of heartburn and/or reflux? (such as calcium carbonate, aluminum hydroxide, and other antacids).0 days are 0 points, 1 day is 1 point, 2-3 days are 2 points, and 4-7 days are 3 points. Add up the scores for each item to obtain the total score.
Measured: at 0, 3, 6 ,12 ,24,36 months follow- up
DeMeester score
Esophageal 24-hintraluminal ambulatory pH monitoring is performed to monitor the modality of the reflux. A catheter sensor is placed 5 cm above the proximal border of the lower esophageal sphincter (LES). Each reflux is considered acidic when the pH of the refluxate is less than 4. The acid reflux composite score (DeMeester score) is calculated using the following values: percentage of total time in reflux, percentage of time in reflux in the upright position, percentage of time in reflux in the supine position, the total number of reflux episodes, number of reflux episodes continuing over 5 minutes, and longest duration of reflux among all reflux episodes
Measured: at 0, 6 and 24 months follow- up
Presence of reflux esophagitis
Healing of esophagitis will represent a clinically significant improvement. Treatment success will be defined by a significantly (p < 0.05) higher number of patients with healed esophagitis in the ARMV group vs. PPI group.
Measured: at 0, 6 and 24 months follow- up
Appearance of the mucosal flap
The shape and mobility of the anti-reflux mucosal flap displayed under endoscopy
Measured: at 6 and 24 months follow- up
PPI use
Requirement of PPI for control of symptoms. Heartburn and Regurgitation questionnaire 0 =No symptom 1 =Symptoms noticeable but not bothersome 2=Symptoms noticeable and bothersome but not every day 3 =Symptoms bothersome every day 4 =Symptoms affect daily activity 5 =Symptoms are incapacitating to do daily activities.
Measured: at 0, 3, 6 ,12 ,24,36 months follow- up
Incidence of adverse events
The incidence of intraoperative and postoperative bleeding and perforation; Postoperative pain score
Measured: at 3, 6 ,12 ,24,36 months follow- up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start10 Sep 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University
- Responsible party
- Principal investigator, Lu Jiaoyang, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348420
- Sponsor's protocol ID
- 2023-QILU-LU 03
- Acronym
- ARMV
- Status last verified
- Nov 2024
- First submitted
- 22 Mar 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not currently plan to grant public access to the participant-level dataset due to privacy concerns and data protection regulations. However, data access may be considered upon reasonable request, subject to ethical and regulatory approvals, to ensure compliance with participant confidentiality and legal requirements.
Publications
Lv X, Ma W, Zeng Y, Lu J. Antireflux mucosal valvuloplasty versus proton pump inhibitors for the treatment of patients with gastro-oesophageal reflux disease in a tertiary healthcare centre in China: study protocol for a randomised controlled trial. BMJ Open. 2024 Dec 22;14(12):e088970. doi: 10.1136/bmjopen-2024-088970.
PubMed 39773838
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06348420
- Acronym / sponsor ID
- ARMV / 2023-QILU-LU 03
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Endoscopic anti-reflux, Proton pump inhibitor, Randomized controlled trial, Gastroesophageal reflux disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong University
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 4 Apr 2024 (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.
The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
Detailed description
Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV.
During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.
After the ARMV procedure, PPI therapy is continued for 1 month to promote mucosal healing before being discontinued. If symptoms reoccur, the PPI management regimen is reinstated for the ARMV group, with diligent recording of PPI usage in a medication diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARMV (intervention group) | Experimental | Procedure: anti-reflux mucosal valvuloplasty (ARMV)Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV. |
| PPI (control group) | No intervention | –Patients randomized to the PPI group will follow the PPI treatment scheme. If GERD symptoms are effectively controlled with their current PPI dosage for at least one month, the regimen is decreased by one step. Conversely, if symptoms are poorly controlled, the dosage is increased by one step based on the PPI algorithm, which aligns with best clinical practices. The use of PPI will be recorded in medication diaries using generic names listed in the table below and classified according to the daily dose and frequency. Dosage will be categorized as "double dose" = ≥30 or 40 mg per day, "full dose" = 30 or 40 mg per day, "half dose" = 15 or 20 mg per day, "occasional" or "on demand" = < "full dose" taken for < 50% of days in the follow-up period. Common medications include Nexium 20mg、Prevacid 30mg、Prilosec 20mg、Protonix 20mg、Aciphex20mg.The frequency of medication use is once a day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 18-60 years of age;
- Hiatal hernia ≤ 2 cm;
- Sliding hernia ≤ 2 cm;
- Recurrence of GERD symptoms after cessation of PPIs;
- On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;
Key exclusion criteria (13 listed)
- BMI > 35 kg/m2;
- ASA > II;
- Barrett's esophagus;
- Hiatal hernia > 2 cm;
- Esophagitis (Los Angeles Classification) Grade A or No 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 |
|---|---|---|
| anti-reflux mucosal valvuloplasty (ARMV)During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3/4-4/5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa/smooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps. | Procedure or surgery | ARMV (intervention group) |
Primary outcome
GERD-HRQL
Time frame: at 0, 6 months follow- up
Questionnaire (GERD-HRQL) : Total Score: Calculated by summing the individual scores to questions 1-15 Greatest possible score (worst symptoms)= 75 Lowest possible score (no symptoms)= 0 Heartburn Score: Calculated by summing the individual scores to questions 1-6 . Worst heartburn symptoms = 30 No heartburn symptoms= 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate heartburn elimination. Regurgitation Score: Calculated by summing the individual scores to questions10-15. Worst regurgitation symptoms = 30 No regurgitation symptoms = 0 Scores of ≤ 12 with each individual question not exceeding 2 indicate regurgitation elimination.
6 secondary outcomes
GERD-Q score
Time frame: at 0, 3, 6 ,12 ,24,36 months follow- up
DeMeester score
Time frame: at 0, 6 and 24 months follow- up
Presence of reflux esophagitis
Time frame: at 0, 6 and 24 months follow- up
Appearance of the mucosal flap
Time frame: at 6 and 24 months follow- up
PPI use
Time frame: at 0, 3, 6 ,12 ,24,36 months follow- up
Incidence of adverse events
Time frame: at 3, 6 ,12 ,24,36 months follow- up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Derived from this study: PubMed 39773838Lv X, Ma W, Zeng Y, Lu J. Antireflux mucosal valvuloplasty versus proton pump inhibitors for the treatment of patients with gastro-oesophageal reflux disease in a tertiary healthcare centre in China: study protocol for a randomised controlled trial. BMJ Open. 2024 Dec 22;14(12):e088970. doi: 10.1136/bmjopen-2024-088970.
- Individual participant dataSharing planned: No. We do not currently plan to grant public access to the participant-level dataset due to privacy concerns and data protection regulations. However, data access may be considered upon reasonable request, subject to ethical and regulatory approvals, to ensure compliance with participant confidentiality and legal requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-reflux mucosal valvuloplasty (ARMV) in people with Gastroesophageal Reflux Disease, run by Qilu Hospital of Shandong University at 1 site in China.
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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 18 Nov 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jiaoyang j lu (18560089069, lujiaoyang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD-HRQL (time frame: at 0, 6 months follow- up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348420, which also lists 1 linked publication.
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 18 Nov 2024.