PMID- 18071818
OWN - NLM
STAT- MEDLINE
DCOM- 20080306
LR  - 20211020
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Linking)
VI  - 22
IP  - 2
DP  - 2008 Feb
TI  - Endoluminal fundoplication by a transoral device for the treatment of GERD: A 
      feasibility study.
PG  - 333-42
AB  - BACKGROUND: A new endoluminal fundoplication (ELF) technique performed 
      transorally using the EsophyXtrade mark device was evaluated for the treatment of 
      gastroesophageal reflux disease (GERD) in a prospective, feasibility clinical 
      trial. METHODS: Nineteen patients were enrolled into the study. Inclusion 
      criteria were chronic and symptomatic GERD, proton pump inhibitor (PPI) 
      dependence, and the absence of esophageal motility disorder. Two patients were 
      excluded due to esophageal stricture and a 6 cm hiatal hernia. The median 
      duration of GERD symptoms and PPI use in the remaining 17 patients was 10 and 6 
      years, respectively. The ELF procedure was designed to partially reconstruct the 
      antireflux barrier through the creation of a valve at the gastroesophageal 
      junction. RESULTS: The ELF-created valves had a median length of 4 cm (range 3-5 
      cm) and circumference of 210 degrees (180-270 degrees ). Adherence of the valves 
      to the endoscope was tight (n = 14) or moderate (n = 3). Hiatal hernias present 
      in 13 patients (76%) were all reduced. Adverse events were limited to mild or 
      moderate pharyngeal irritation and epigastric pain, which resolved spontaneously. 
      After 12 months, the ELF valves (n = 16) had a median length of 3 cm (1-4 cm) and 
      a circumference of 200 degrees (150-210 degrees ). Eighty-one percent of valves 
      retained their tightness. The hiatal hernias present at the baseline remained 
      reduced in 62% of patients. The median GERD-HRQL scores improved by 67% (17-6), 
      and nine patients (53%) improved their scores by >or=50%. Eighty-two percent of 
      patients were satisfied with the outcome of the procedure, 82% remained 
      completely off PPIs, and 63% had normal pH. CONCLUSION: The study demonstrated 
      technical feasibility and safety of the ELF procedure using the EsophyX device. 
      The study also demonstrated maintenance of the anatomical integrity of the ELF 
      valves for 12 months and provided preliminary data on ELF efficacy in reducing 
      the symptoms and medication use associated with GERD.
FAU - Cadiere, G B
AU  - Cadiere GB
AD  - Centre Hospitalier, Universitaire St. Pierre, 322, rue Haute, Brussels, 1000, 
      Belgium. guy_cadiere@stpierre-bru.be
FAU - Rajan, A
AU  - Rajan A
FAU - Germay, O
AU  - Germay O
FAU - Himpens, J
AU  - Himpens J
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20071211
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
SB  - IM
MH  - Adult
MH  - Equipment Design
MH  - *Esophagoscopy
MH  - Feasibility Studies
MH  - Female
MH  - Fundoplication/*instrumentation/*methods
MH  - Gastroesophageal Reflux/*surgery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
EDAT- 2007/12/12 09:00
MHDA- 2008/03/07 09:00
CRDT- 2007/12/12 09:00
PHST- 2007/04/13 00:00 [received]
PHST- 2007/08/29 00:00 [accepted]
PHST- 2007/07/10 00:00 [revised]
PHST- 2007/12/12 09:00 [pubmed]
PHST- 2008/03/07 09:00 [medline]
PHST- 2007/12/12 09:00 [entrez]
AID - 10.1007/s00464-007-9618-9 [doi]
PST - ppublish
SO  - Surg Endosc. 2008 Feb;22(2):333-42. doi: 10.1007/s00464-007-9618-9. Epub 2007 Dec 
      11.