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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Elimination of Regurgitation and Troublesome Atypical Symptoms - RDQ [Time frame: 1 year]
• Elimination of Regurgitation and Troublesome Atypical Symptoms - GERD-QOL [Time frame: 1 year]

Secondary outcome measures (5)

• Improvement of Symptom Scores - RDQ [Time frame: at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF]
• Improvement of Symptom Scores - GERD-QOL on PPI [Time frame: at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF]
• Improvement of Symptom Scores - GERD-QOL off PPI [Time frame: at 4 Weeks, 3, 12, 24, 36, 48, 60 months post-TIF]
• Dosage and Frequency of Proton Pump Inhibitors Usage [Time frame: 5 years from recruitment]
• Measurement for Reflux [Time frame: At recruitment, 12 months Post-TIF, 24 months post-TIF, 36 months post-TIF, 48 months post-TIF and 60 months post-TIF]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Chinese University of Hong Kong, Shatin, HK — Hong Kong

Identifiers

NCT: NCT07556289 · 2021.417

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗