Transoral Incisional Fundoplication (TIF) for Patients Suffering From Gastroesophageal Reflux Disease in an Asian Population

Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The technique offers an acceptable alternative to surgery, mimicking partial fundoplication, but less invasive and with no persistent side effects, in patients with proven pathological GERD with either a competent gastroesophageal valve or hiatal hernia, not longer than 3cm, who refuse, are intolerance, or are unresponsive to PPI maintenance therapy. Laparoscopic fundoplication, although still considered to be the gold-standard approach for GERD refractory to medical treatment, does involve some risk of long-term adverse events such as dysphagia (5-12%), inability to vomit or belch, gas/bloat syndrome (19%) and excessive flatulence.

Several prospective observational studies and some comparative trials have proved efficacy of TIF with EsophyX in obtaining a significant reduction in the acid exposure time (AET) assessed by esophageal 24-hour pH-impedance monitoring versus sham, and in controlling both typical and atypical GERD symptoms for up to 1 to 2 years, as reported in a meta-analysis7. Outcomes at 3, 5, and 10 years have been reported in different studies and showed to be favourable. In an Italian study reporting the 10 year follow-up, the GERD-HRQL score, heartburn and regurgitation score were significantly lower than pre-procedure and did not change significantly during the follow-up. The rates of patients who had stopped or halved anti-secretive therapy 2, 3, 5, 7 and 10 years after the procedure were 86.7%, 84.4%, 73.5%, 83.3% and 91.7% respectively.

This procedure, however, has not been performed in Asia patients. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population.

In patients who fulfil the inclusion criteria, TIF will be performe under general anaesthesia. They will then be followed-up at 4 weeks, 3 months, then yearly for up to 5 years after the procedure. The anti-reflux control and adverse events will be recorded.

Study Overview

• Status: Recruiting
• Conditions: GERD; Fundoplication
• Intervention / Treatment: Procedure: Transoral incisional fundoplication

Detailed Description

Transoral incisionless fundoplication (TIF) has become a widely used intervention to restore the valve at the gastroesophageal junction in selected patients suffering from gastroesophageal reflux disease (GERD). More than 20,000 procedures have been performed worldwide. TIF with EsophyX device reconfigures the tissue to establish an omega-shaped full-thickness gastroesophageal valve from inside the stomach. The procedure creates serosa to serosa plications which include the muscle layers and constructs valves 3-5cm long, taking in 200-270 degrees of the circumference, and deploying multiple non-absorbable polypropylene fasteners through the two layers in a circumferential patten around the gastroesophageal junction. Data so far indicate that, in the majority of patients, the procedure achieves lasting improvement in GERD symptoms measured by either pH or impedance monitoring. The technique offers an acceptable alternative to surgery, mimicking partial fundoplication, but less invasive and with no persistent side effects, in patients with proven pathological GERD with either a competent gastroesophageal valve or hiatal hernia, not longer than 3cm, who refuse, are intolerance, or are unresponsive to PPI maintenance therapy. Laparoscopic fundoplication, although still considered to be the gold-standard approach for GERD refractory to medical treatment, does involve some risk of long-term adverse events such as dysphagia (5-12%), inability to vomit or belch, gas/bloat syndrome (19%) and excessive flatulence. Several prospective observational studies and some comparative trials have proved efficacy of TIF with EsophyX in obtaining a significant reduction in the acid exposure time (AET) assessed by esophageal 24-hour pH-impedance monitoring versus sham, and in controlling both typical and atypical GERD symptoms for up to 1 to 2 years, as reported in a meta-analysis7. Outcomes at 3, 5, 6 and 10 years have been reported in different studies and showed to be favourable. In an Italian study reporting the 10-year follow-up, the GERD-HRQL score, heartburn and regurgitation score were significantly lower than pre-procedure and did not change significantly during the follow-up. The rates of patients who had stopped or halved anti-secretive therapy 2, 3, 5, 7 and 10 years after the procedure were 86.7%, 84.4%, 73.5%, 83.3% and 91.7% respectively.

This procedure, however, has not been performed in Asia patients. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population.

This study will show that TIF, apart being effective in western population, is also feasible and effective in Asian patients.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shannon Melissa CHAN, MBChB, FRCSEd, FHKAM (Surgery); Phone Number: +852 3505 2956; Email: shannonchan@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong, Shatin, HK
    • Contact: Shannon Melissa CHAN, MBChB, FRCSEd, FHKAM (Surgery); Phone Number: +852 3505 2956; Email: shannonchan@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years - 80 years of age
• More than 6 months of GERD symptoms and troublesome regurgitation, despite a minimum PPI dose of 40 mg daily. Troublesome regurgitation was defined as mild symptoms for 2 or more days per week or moderate to severe symptoms more than 1 day per week, per Montreal consensus criteria. Patients will be followed-up for 5 years.
• Symptom assessment used the following 3 validated tools: the Reflux Disease Questionnaire (RDQ), and the GERD-QOL score on PPI and off PPI for at least 7 days.
• Abnormal amounts of gastroesophageal reflux off PPI for 7 days was confirmed by distal esophageal pH <4 for >5.3% of at least 1 of the 2 days that pH was measured with a Bravo (radiotelemetry) probe (Given Imaging, Yoqneam, Israel).

Exclusion Criteria:

• Systemic disease not well controlled
• Obesity determined by body mass index >35
• Esophageal ulcer, stricture
• Barrett's esophagus >2 cm in length
• Hiatal hernia >2 cm in length
• Los Angeles grade C or D esophagitis
• Peptic ulcer disease
• Gastroparesis
• Pregnancy or plans for pregnancy in the next 12 months
• Immunosuppression
• Portal hypertension
• Coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Transoral incisional fundoplication; Transoral incisional fundoplication for GERD patients

Procedure: Transoral incisional fundoplication; Transoral incisional fundoplication offered for GERD patients. This procedure, however, has not been performed in Asia patients, even with previous success with other studies. Asians have smaller body build and is known to have less GERD when compared to the Caucasian population. This study, therefore, is a feasibility study to perform TIF in an Asian population; Other Names: GERD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elimination of Regurgitation and Troublesome Atypical Symptoms - RDQ	Elimination of troublesome regurgitation and elimination of all troublesome atypical symptoms at the 1-year follow-up as evaluated by the Reflux Disease Questionnaire (RDQ). RDQ with total score ranging from 0 to 18 based on symptom frequency over the past week. Higher score indicates a higher likelihood of GERD, and it is also used to measure treatment response.	1 year
Elimination of Regurgitation and Troublesome Atypical Symptoms - GERD-QOL	Elimination of troublesome regurgitation and elimination of all troublesome atypical symptoms at the 1-year follow-up as evaluated by the GERD-QOL score.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Symptom Scores - RDQ	Measuring the improvement in symptom scores using the (RDQ) at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF. RDQ with total score ranging from 0 to 18 based on symptom frequency over the past week. Higher score indicates a higher likelihood of GERD, and it is also used to measure treatment response.	at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Improvement of Symptom Scores - GERD-QOL on PPI	Measuring the improvement in symptom scores using the GERD-QOL score on PPI at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF. The GERD-QOL questionnaire is an 18-item instrument assessing the impact of gastroesophageal reflux disease on daily life, including sleep, diet, work, and social activity over the past 7 days. It uses a 5-point scale per item (0=Strongly agree to 4=Strongly disagree), where a higher score indicates a better quality of life.	at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Improvement of Symptom Scores - GERD-QOL off PPI	Measuring the improvement in symptom scores using the GERD-QOL score off PP at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF	at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF
Dosage and Frequency of Proton Pump Inhibitors Usage	The usage of proton pump inhibitor, that is dosage of frequency of its use for the patients will be recorded	5 years from recruitment
Measurement for Reflux	24hr pH study will be used for determining the reflux situation for patients, post-surgery.	At recruitment, 12 months Post-TIF, 24 months post-TIF, 36 months post-TIF, 48 months post-TIF and 60 months post-TIF

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: GERD; Fundoplication
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: 2021.417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No