Back to resultsARMA for Postoperative GERD After Sleeve Gastrectomy
Primary Purpose
Gastroesophageal Reflux
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Anti-reflux mucosal ablation
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux
Eligibility Criteria
Inclusion Criteria:
- Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
- Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% on pH study
Exclusion Criteria:
- Primary esophageal motility disorders
- Sliding hiatal hernia >3cm
- Narrow gastric sleeve that precludes retroflexion of scope
- Gastric sleeve stricture
- Malignancy
- Pregnancy
- Patients not fit for general anesthesia
- Other cases deemed by the examining physician as unsuitable for safe treatment
- Refusal to participate
Sites / Locations
- Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anti-reflux mucosal ablation
Arm Description
This technique creates an anti-reflux mechanism by performing mucosal ablation at the gastric cardia and inducing cicatrisation, and thereby rebuilds the flap valve at the gastric cardia
Outcomes
Primary Outcome Measures
Change in GERD symptoms
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome]
Change in GERD symptoms
astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome]
Secondary Outcome Measures
Technical success rate
defined as successful completion of endoscopic procedure
Change in DeMeester score and AET
evaluated by 24-hour pH monitoring
Dysphagia symptoms
evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome]
PPI use
dosage of PPI use after procedure
Changes in cardia morphology
endoscopic assessment of Hill's flap grade
Adverse events rate relating to endoscopic intervention
complication including bleeding, perforation and stricture
Full Information
NCT ID
NCT05259579
First Posted
January 26, 2022
Last Updated
February 17, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05259579
Brief Title
ARMA for Postoperative GERD After Sleeve Gastrectomy
Official Title
Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anti-reflux mucosal ablation
Arm Type
Experimental
Arm Description
This technique creates an anti-reflux mechanism by performing mucosal ablation at the gastric cardia and inducing cicatrisation, and thereby rebuilds the flap valve at the gastric cardia
Intervention Type
Procedure
Intervention Name(s)
Anti-reflux mucosal ablation
Other Intervention Name(s)
ARMA
Intervention Description
Mucosal ablation is planned around the cardia on the gastric side in a butterfly shape. Submucosal layer is raised by injecting saline with indigo carmine dye. Mucosal ablation is performed using the triangle-tip knife in spray coagulation mode.
Primary Outcome Measure Information:
Title
Change in GERD symptoms
Description
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome]
Time Frame
3 and 6months
Title
Change in GERD symptoms
Description
astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome]
Time Frame
3 and 6months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
defined as successful completion of endoscopic procedure
Time Frame
1 day
Title
Change in DeMeester score and AET
Description
evaluated by 24-hour pH monitoring
Time Frame
3 months
Title
Dysphagia symptoms
Description
evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome]
Time Frame
3 and 6 months
Title
PPI use
Description
dosage of PPI use after procedure
Time Frame
3 and 6 months
Title
Changes in cardia morphology
Description
endoscopic assessment of Hill's flap grade
Time Frame
3 months
Title
Adverse events rate relating to endoscopic intervention
Description
complication including bleeding, perforation and stricture
Time Frame
7 days, 1, 3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% on pH study
Exclusion Criteria:
Primary esophageal motility disorders
Sliding hiatal hernia >3cm
Narrow gastric sleeve that precludes retroflexion of scope
Gastric sleeve stricture
Malignancy
Pregnancy
Patients not fit for general anesthesia
Other cases deemed by the examining physician as unsuitable for safe treatment
Refusal to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Ng, FRCSEd(Gen)
Phone
+85235052956
Email
stephenng@surgery.cuhk.edu.hk
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen KK Ng, FRCSEd(Gen)
Phone
+85235052956
Email
stephenng@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Simon KH Wong, FRCSEd(Gen)
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
ARMA for Postoperative GERD After Sleeve Gastrectomy
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