Less Invasive Treatment Option for GERD May Offer Similar Results to Gold Standard

A less invasive treatment option for gastroesophageal reflux disease (GERD) resulted in similar improvements in symptoms and quality of life with less dysphagia compared with gold-standard surgical therapy, according to a prospective randomized study.

At 6 months, the adjusted mean difference in score on the GERD Health-Related Quality of Life (HRQL) between patients undergoing laparoscopic hiatal hernia repair with consecutive transoral incisionless fundoplication (cTIF) versus those undergoing hernia repair with laparoscopic Nissen fundoplication (LNF) was 2.04 (95% CI -0.88 to 4.95), which fell below the prespecified non-inferiority margin of 4.9 points (15% of baseline), according to Barham K. Abu Dayyeh, MD, MPH, of Cedars Sinai Medical Center in Los Angeles.

Improvements in most outcomes were similar between the groups, but patients undergoing cTIF also experienced less difficulty swallowing afterward, he reported at Digestive Disease Week.

The cTIF procedure is a “novel, less invasive hybrid approach to treating GERD” that “combines a laparoscopic repair of hernia with an endoscopic, through-the-mouth reconstruction of the valve,” Abu Dayyeh told MedPage Today. “This offers a collaborative, minimally invasive option that can expand access to effective treatment for GERD.”

Among an estimated 76 million patients with GERD in the U.S., about 20 million manage their symptoms with daily proton pump inhibitors (PPIs), but these only reduce acidity without restoring the anti-reflux barrier, Abu Dayyeh said. Millions of people continue to experience breakthrough symptoms with PPIs while also dealing with their side effects. Only about 30,000 people — less than 0.5% of those with GERD — undergo reflux surgery, he said.

LNF is the gold-standard surgery for GERD, but its technical complexity and side effects, such as dysphagia and gas bloating, have limited its scalability; cTIF is less invasive and anatomically restores the anti-reflux barrier, has fewer side effects, and is technically simpler, making it potentially more scalable, he said.

In the study, Daily Burden of Reflux scores showed similar improvement between the groups. Dysphagia scores improved 1.8 points from baseline with cTIF and 1.2 points with LNF at 12 months (P=0.3), and bloating scores at 12 months improved 3.2 points in cTIF participants and 2.3 points in LNF participants (P=0.1).

Incident bloating rates were also similar across both groups, but dysphagia incidence was significantly higher in the LNF group at 6 months (32.3% vs 2.6%, P=0.0008) and 12 months (28.6% vs 5.7%, P=0.01).

Neena Mohan, MD, director of Barrett’s Esophagus and Esophageal Research at the Temple Health Esophageal Disease Program in Philadelphia, told MedPage Today that “having more options for GERD management is beneficial for patient care,” though further studies are important to evaluate how the advantages of cTIF seen in this study, such as decreased bloating and dysphagia, play out longer term.

“Patient selection and operator experience are important to consider when selecting procedural or surgical options,” added Mohan, who was not involved with the research. “As more data becomes available, cTIF may be considered more widely.”

This non-inferiority trial randomized 164 patients to LNF or cTIF in seven U.S. centers; 132 underwent intervention (64 and 68 patients, respectively). Participants were an average of 55 years old with an average body mass index (BMI) of 28.4.

There were no significant differences in prevalence of hypertension and type 2 diabetes between the groups. At baseline, participants had an average 11.4% acid exposure time (AET), while scores on the GERD-HRQL were 34.5 in the cTIF group and 30.9 in the LNF group and DeMeester scores were 36.4 versus 40.2, neither of which were significantly different.

At 6 months, GERD-HRQL scores improved by 27.4 points in the cTIF group and 26.9 points in the LNF group (P=0.89). At 12 months, GERD-HRQL scores improved by 29.6 points and 27.2 points, respectively (P=0.47), for an adjusted mean difference of -0.4, again within the 15% non-inferiority margin.

Absolute and percent improvements on the Gastrointestinal Quality of Life Index were also similar between the groups at 6 and 12 months across GI symptoms, physical, and social domains.

There were also no significant differences between the cTIF and LNF groups in:

• Mean change in AET at 6 months: -9.6% vs -10.3%, P=0.71
• Mean change in DeMeester scores at 6 months: -28.3 vs -36.2, P=0.10
• Discontinued PPIs at 6 months: 95.5% vs 95.1%
• Discontinued PPIs at 12 months: 91.7% vs 92.2%

Serious adverse events were similar in the treatment arms, with 2.9% major complications with cTIF and 1.6% with LNF, and 90-day reintervention rates of 1.5% with cTIF and 1.6% with LNF (P=1.00 for both).

“It is important to note that this study focused on patients with smaller hiatal hernias of 5 cm or less,” Abu Dayyeh told MedPage Today. “Overall, this does not replace reflux surgery, but adds a validated less invasive option with sustained outcome that can expand access to effective GERD interventions.”