ARMA for Postoperative GERD After Sleeve Gastrectomy

February 17, 2022 updated by: Stephen K.K. Ng, Chinese University of Hong Kong

Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Chinese University of Hong Kong
        • Contact:
        • Sub-Investigator:
          • Simon KH Wong, FRCSEd(Gen)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-reflux mucosal ablation
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
Procedure: Anti-reflux mucosal ablation
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.
Other Names:
  • ARMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GERD symptoms
Time Frame: 3 and 6months
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome]
3 and 6months
Change in GERD symptoms
Time Frame: 3 and 6months
astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome]
3 and 6months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: 1 day
defined as successful completion of endoscopic procedure
1 day
Change in DeMeester score and AET
Time Frame: 3 months
evaluated by 24-hour pH monitoring
3 months
Dysphagia symptoms
Time Frame: 3 and 6 months
evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome]
3 and 6 months
PPI use
Time Frame: 3 and 6 months
dosage of PPI use after procedure
3 and 6 months
Changes in cardia morphology
Time Frame: 3 months
endoscopic assessment of Hill's flap grade
3 months
Adverse events rate relating to endoscopic intervention
Time Frame: 7 days, 1, 3 and 6 months
complication including bleeding, perforation and stricture
7 days, 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

July 31, 2023

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2021.553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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