A Novel therapy for GERD! data from single centre study shows promising results.

we all know the patients with GERD, most of them are dependant on Proton pump inhibitors (PPI), there were surgeries for these patients who have inadequate response to PPI, how ever, their symptoms usually relapse after 5 to 10 years of surgery. (1)

Endoscopy fundoplication is another alternative to surgery. it is performed in patients dependent on PPI with not much of symptom improvement. it includes the use of a device which is passed through endoscope biopsy port and the full thickness sutures are placed in the gastro-oesophageal junction (G-E junction). Most of the available data is with Esophyx device. (2)

A new study was recently published in Gut, by Dr. Rakesh Kalapala, Dr. G Nageshwar reddy of asian institute of gastroenterology, Hyderabad. In this study they used a new device GERD-X by G-SURG, Germany.

GERD-X device from G-surg, Germany.

The study was a double-blind, single centre, randomised control trial, published on April 13, 2021 in GUT.

In this study they assessed the efficacy and safety of this novel device (GERD-X) for EFTP (endoscopic full thickness fundoplication). The study was performed during October 2017 to April 2019.

Patients aged 18-60years with classic reflux symptoms (heartburn, regurgitation) and dependent on PPI for at least 6 months were screened and were included in their study. of whom, 70 were selected and were randomised into two groups intervention arm and sham-procedure arm with 35 each.

The intervention arm received EFTP with GERD-X device, where the device was introduced through biopsy port till the G-E junction and transmural sutures were placed for plication and tight closure of G-E junction.

These patients were followed up till 1 year. The study endpoints were reduction of 50% or more in GERD-HRQL score from baseline at 3 months as primary endpoint, and improvement in GERD-HRQL total score, improvement in GERD symptom scores at 3,6, 12 months, PPI usage and oesophageal acid exposure and reflux episodes at 24hr pH impedance monitoring at 3 and 12 months.

Primary end point. The endoscopic full-thickness plication (EFTP; GERDx) group achieved ≥50% improvement in GERD-HRQL total score more frequently than the sham group at 3 months post intervention. GERD-HRQL, GERD health-related quality of life; GERDx or EFTP, endoscopic full-thickness fundoplication.

They found 65.7% patients achieved primary endpoint in intervention arm compared to only 2.9% in the sham-procedure arm which is huge!. There was significant improvement in GERD-HRQL score at3 and 12 months. however, 24hr pH impedance studies showed partial improvement at 3months.

This procedure is quick and easy to perform, the mean time of procedure in this study was just 17.4min. And there were not many complications seen.

so overall, this is a new promising alternative option to surgery, to be chosen in appropriately selected patients. however, this is a single centre study, larger studies are required and long-term followup data is not available with this device and further studies are required.

(1) Lundell L, Bell M, Ruth M. Systematic review: Laparoscopic fundoplication for gastroesophageal reflux disease in partial responders to proton pump inhibitors. World J Gastroenterol 2014; 20(3): 804-813 [PMID: 24574753 DOI: 10.3748/wjg.v20.i3.804]

(2) McCarty  TR, Itidiare  M, Njei  B, et al. Efficacy of transoral incisionless fundoplication for refractory gastroesophageal reflux disease: a systematic review and meta-analysis. Endoscopy2018;50:708–25. doi:10.1055/a-05766589 pmid: http://www.ncbi.nlm.nih.gov/pubmed/29625507

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