Endoscopic full-thickness plication for the treatment of GERD by application of multiple Plicator implants: a multicenter study (with video).
BACKGROUND
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.


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


METHODS
Open-label, prospective, multicenter study.


METHODS
Four tertiary-referral centers.


METHODS
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.


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


METHODS
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).


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


CONCLUSIONS
Endoscopic full-thickness plication with multiple serially placed implants was safe and effective in reducing GERD symptoms, medication use, esophageal-acid exposure, and esophagitis.
von Renteln
Daniel
D
Medizinische Klinik I, Klinikum Ludwigsburg, Ludwigsburg, Germany.
Schiefke
Ingolf
I
Fuchs
Karl-Hermann
KH
Raczynski
Susanne
S
Philipper
Michael
M
Breithaupt
Wolfram
W
Caca
Karel
K
Neuhaus
Horst
H
D016099:Endoscopy, Gastrointestinal / Q000379:methods; D004942:Esophagitis, Peptic / Q000150:complications / Q000473:pathology; D004943:Esophagogastric Junction / Q000601:surgery*; D004947:Esophagus / Q000503:physiopathology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013536:Suture Techniques / Q000009:adverse effects / Q000295:instrumentation*