Endoscopic full-thickness plication for the treatment of GERD by application of multiple Plicator implants: a...

The full-thickness Plicator allows transmural suturing at the gastroesophageal (GE) junction to restructure the antireflux barrier. Studies of the Plicator procedure to date have been limited to placement of a single transmural suture to create the endoscopic gastroplication.

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.

Open-label, prospective, multicenter study.

Four tertiary-referral centers.

Subjects with symptomatic GERD who require daily maintenance proton pump inhibitor (PPI) therapy. Study exclusions were hiatal hernia >3 cm, grades III and IV esophagitis, Barrett's epithelium, and esophageal dysmotility.

Forty-one patients received two or more transmural sutures placed linearly in the anterior gastric cardia approximately 1 cm below the GE junction.

Six months after the procedure, median GERD-health-related quality of life (HRQL) improved 76% compared with off-medication baseline (6.0 vs 25.0, P < .001), with 75% of patients (32/40) achieving >50% improvement in their baseline GERD-HRQL score. Six months after the procedure, daily PPI therapy was eliminated in 70% of patients (28/40). Heartburn symptoms improved 80% compared with off-medication baseline (16.0 vs 84.0, P < .001). Median esophagitis grade improved 75% compared with baseline (0.0 vs 1.0, P = .005). Esophageal pH assessed as median distal esophageal-acid exposure (percentage time pH < 4.0) improved 38% compared with baseline (9.0 vs 11.0, P < .020; nominal P value for a single statistical test: significance removed upon the Bonferroni adjustment for multiple testing of data) and manometric outcomes were also improved compared with baseline (median lower esophageal sphincter resting pressure improved 25% [10.0 vs 6.0, P < .017; nominal P value for a single statistical test: significance removed upon the Bonferroni adjustment for multiple testing of data]) and median amplitude of contraction improved 11% (70.0 vs 62.0, P < .037; nominal P value for a single statistical test: significance removed upon the Bonferroni adjustment for multiple testing of data).

Small sample size. No randomized comparison with a single implant group.

Endoscopic full-thickness plication with multiple serially placed implants was safe and effective in reducing GERD symptoms, medication use, esophageal-acid exposure, and esophagitis.