MedPath

ARMA for Postoperative GERD After Sleeve Gastrectomy

Not Applicable
Conditions
Gastroesophageal Reflux
Registration Number
NCT05259579
Lead Sponsor
Chinese University of Hong Kong
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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
15
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Change in GERD symptoms3 and 6months

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

Secondary Outcome Measures
NameTimeMethod
Technical success rate1 day

defined as successful completion of endoscopic procedure

Changes in cardia morphology3 months

endoscopic assessment of Hill's flap grade

Dysphagia symptoms3 and 6 months

evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score \[0-40, higher score mean worse outcome\]

Adverse events rate relating to endoscopic intervention7 days, 1, 3 and 6 months

complication including bleeding, perforation and stricture

Change in DeMeester score and AET3 months

evaluated by 24-hour pH monitoring

PPI use3 and 6 months

dosage of PPI use after procedure

Trial Locations

Locations (1)

Chinese University of Hong Kong

🇭🇰

Hong Kong, Hong Kong

Chinese University of Hong Kong
🇭🇰Hong Kong, Hong Kong
Stephen KK Ng, FRCSEd(Gen)
Contact
+85235052956
stephenng@surgery.cuhk.edu.hk
Man Yee Yung
Contact
+85235052956
myyung@surgery.cuhk.edu.hk
Simon KH Wong, FRCSEd(Gen)
Sub Investigator
Philip WY Chiu, MD
Sub Investigator

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