NCT05259579

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

January 26, 2022

Last Update Submit

February 17, 2022

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (2)

  • Change in GERD symptoms

    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

    astroesophageal Reflux Disease Questionnaire (GERDQ) score \[0-18, higher scores mean worse outcome\]

    3 and 6months

Secondary Outcomes (6)

  • Technical success rate

    1 day

  • Change in DeMeester score and AET

    3 months

  • Dysphagia symptoms

    3 and 6 months

  • PPI use

    3 and 6 months

  • Changes in cardia morphology

    3 months

  • +1 more secondary outcomes

Study Arms (1)

Anti-reflux mucosal ablation

EXPERIMENTAL

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

Interventions

Anti-reflux mucosal ablationPROCEDURE

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.

Also known as: ARMA
Anti-reflux mucosal ablation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Stephen Ng, FRCSEd(Gen)

CONTACT

+85235052956stephenng@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 28, 2022

Study Start

February 1, 2022

Primary Completion

January 31, 2023

Study Completion

July 31, 2023

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

HK(1)