PMID- 18534586
OWN - NLM
STAT- MEDLINE
DCOM- 20090409
LR  - 20151119
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 68
IP  - 5
DP  - 2008 Nov
TI  - Endoscopic full-thickness plication for the treatment of GERD by application of 
      multiple Plicator implants: a multicenter study (with video).
PG  - 833-44
LID - 10.1016/j.gie.2008.02.010 [doi]
AB  - 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. DESIGN: Open-label, prospective, 
      multicenter study. SETTING: Four tertiary-referral centers. PATIENTS: 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. INTERVENTIONS: 
      Forty-one patients received two or more transmural sutures placed linearly in the 
      anterior gastric cardia approximately 1 cm below the GE junction. MAIN OUTCOME 
      MEASUREMENTS: 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). LIMITATIONS: 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.
FAU - von Renteln, Daniel
AU  - von Renteln D
AD  - Medizinische Klinik I, Klinikum Ludwigsburg, Ludwigsburg, Germany.
FAU - Schiefke, Ingolf
AU  - Schiefke I
FAU - Fuchs, Karl-Hermann
AU  - Fuchs KH
FAU - Raczynski, Susanne
AU  - Raczynski S
FAU - Philipper, Michael
AU  - Philipper M
FAU - Breithaupt, Wolfram
AU  - Breithaupt W
FAU - Caca, Karel
AU  - Caca K
FAU - Neuhaus, Horst
AU  - Neuhaus H
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20080604
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
SB  - IM
CIN - Gastrointest Endosc. 2008 Nov;68(5):845-8. PMID: 18984098
MH  - *Endoscopy, Gastrointestinal/methods
MH  - Esophagitis, Peptic/complications/pathology
MH  - Esophagogastric Junction/*surgery
MH  - Esophagus/physiopathology
MH  - Female
MH  - Gastroesophageal Reflux/complications/physiopathology/*surgery
MH  - Humans
MH  - Male
MH  - Manometry
MH  - Middle Aged
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Suture Techniques/adverse effects/*instrumentation
EDAT- 2008/06/07 09:00
MHDA- 2009/04/10 09:00
CRDT- 2008/06/07 09:00
PHST- 2007/10/19 00:00 [received]
PHST- 2008/02/04 00:00 [accepted]
PHST- 2008/06/07 09:00 [pubmed]
PHST- 2009/04/10 09:00 [medline]
PHST- 2008/06/07 09:00 [entrez]
AID - S0016-5107(08)00220-4 [pii]
AID - 10.1016/j.gie.2008.02.010 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2008 Nov;68(5):833-44. doi: 10.1016/j.gie.2008.02.010. Epub 
      2008 Jun 4.