Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-22
Brief Title:
Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
A Randomized Controlled Trial of Anti-reflux Mucosal Valvuloplasty ARMV Versus Proton Pump Inhibitors PPIs for Treatment of Gastroesophageal Reflux DiseaseGERD The ARMV vs PPIs Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARMV
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 34-45 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 submucosasmooth 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
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 34-45 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 submucosasmooth 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None