Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment

NCT ID: NCT06348420

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2028-12-30

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ARMV (intervention group)

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.

Group Type: EXPERIMENTAL

anti-reflux mucosal valvuloplasty (ARMV)

Intervention Type: PROCEDURE

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.

PPI (control group)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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;
• 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.

Exclusion Criteria

• 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；
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Lu Jiaoyang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

jiaoyang j lu

Role: CONTACT

lujiaoyang@sdu.edu.cn

18560089069

Facility Contacts

xiaofen lv

Role: primary

lxf202215602@163.com

15670188361

References

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.

Reference Type: DERIVED

PMID: 39773838 (View on PubMed)

Other Identifiers

2023-QILU-LU 03

Identifier Type: -

Identifier Source: org_study_id