1. S1177
Gatekeeper Therapy: An Endoscopic Treatment for GERD:
Randomized, Sham-Controlled Multi-Center Trial Overview
Paul Fockens, Aaltje Lei, Steven Edmundowicz, Mike Lehmkuhl,
Lawrence Cohen, Colleen D’Souza, Richard Rothstein, Carol Moriarty,
Nicholas Nickl, Sylvia Nicholson, Bergein F. Overholt, Janet Miller,
C.D. Smith, Vickie Swafford, Kenneth Binmoeller, Danielle Hauptman,
Nimish Vakil, Ahmad Dalmar, Peter J. Kahrilas, Christine Ebert,
Thomas Lee, Karen Hieston, Glen A. Lehman
Background: The Gatekeeper Ô Reflux Repair System (Medtronic, Shoreview, MN)
is a promising endoscopic therapy that is designed to augment the functioning of
the lower esophageal sphincter through the implantation of prostheses into the
submucosal layer of the LES in an outpatient procedure. These prostheses, made of
a biocompatible hydrogel material, expand upon contact with moisture, creating
a mechanical barrier between the stomach and the esophagus, restricting the flow
of gastric contents into the esophagus. Preliminary data from 68 patients in
a European Multi-center study showed implantation of approximately 4 prostheses
at the LES improved GERD symptoms in a majority of PPI dependent GERD
patients. Aim: To evaluate the effects of the Gatekeeper Therapy in symptomatic
GERD patients in a large, prospective, multi-center, randomized, sham-controlled
study. Method: Recruitment is ongoing for a Multicenter U.S./European study.
Inclusion criteria include: Symptomatic GERD with symptom control on PPI
therapy. Baseline 24 hr with pH!Z4.0 ZO4% of time. Baseline GERD-
HRQL OZ20 off PPI. Exclusion criteria: Barrett’s O 2cm, strictures, varices, grade 3
or greater esophagitis, hiatal hernia O 3cm, prior anti-reflux surgery. Procedure:
Implant 4 prostheses circumferentially in LES. 144 patients will be randomized by
a sealed envelope at ratio of 2:1 implant vs. sham. Blind will be broken at 6 months,
with sham patients offered Gatekeeper therapy. Outcome parameters being
evaluated include HRQL, esophagitits, medication use, 24 hr pH, and implant
persistence. Results: Enrollment started 09/24/03 with 210 subjects enrolled and
52 subjects randomized and implanted to date (12/01/04). Summary: The study is
ongoing with enrollment completion anticipated by April, 2005.
S1178
Endoscopic Suturing for GERD: Results at One Year Precludes the
Use in Routine Practice
Elodie Lepoutre, Jean Boyer, Jean-Charles Grimaud,
Jean-Christophe Letard, Jean Escourrou, Frederic Prat,
Philippe Ducrotte, Jean-Marc Canard, Jean-Francois Rey,
Thierry Ponchon, CRD, SFED
Introduction: The long term efficiency of endoscopic suturing will determine his
role in routine practice for the treatment of GERD. We reviewed the one year
results of the multicenter French trial. Patients and Methods: Inclusion criteria were
1-symptomatic GERD (GERD-HRQLO20 without treatment), 2-effective PPI therapy
for more than 3 months, 3- absence of hiatal hernia more than 2 cm or Barett’s.
Plications with the Endocinch-Bard System were performed in the axis of the lesser
curve , the proximal on the squamo-columnar junction. The one year follow-up
recorded adverse events, the PPI medication use, GERD-HQRL and quality of life
score. An endoscopy was performed at one year. Results: Sixty patients (pts) were
included (4 patients had 2 sessions of suturing). A mean of 2.8 plications per pt was
used. All side-effects were early and rapidly resolutive : dysphagia (18%),
retrosternal or pharyngeal pain (13%). 7 patients refused endoscopic control or
were lost of follow-up. Two of the 53 pts reviewed at 1 year have undergone surgery.
Improvement of the GERD-HQRL and quality of life score was shown at 1 year. The
percentage of patients without PPI was 53% at one year. For the 12 pts reviewed at
18 months, the rate of pts without PPI stayed at 50%. Gastroscopy at one year
showed that only 49% of the initial plications were in place. Eigtheen % of pts had
always all plications, while 18% had no one. Conclusion: Although the procedure
was safe and 50% of patients stopped PPI, the lost of more than 50% of plications at
one year let predict that Endocinch cannot be a valuable alternative to long term
medical therapy. Some technical progress should be done to make deeper stitches.
S1179
A Prospective Multicenter Trial on Ablation of Non-Neoplastic
Barrett’s Epithelium by Endoscopic Argon Plasma Coagulation
in Combination with Esomeprazole (APBANEX)
Hendrik Manner, Andrea May, Stephan Miehlke, Walter Kraemer,
Gabriele Niemann, Bernd Wigginghaus, Stephan Dertinger,
Wolfgang Schimming, Ralf Kiesslich, Manfred Stolte, Christian Ell
Background: In contrast to former clinical trials concerning the ablation of non-
neoplastic Barrett’s epithelium (BE), Schulz et al. (Gastrointest Endosc, 2000)
obtained a complete squamous regeneration after argon plasma coagulation (APC)
in 98,6% of treated patients. The aim of this prospective study was to evaluate for
the first time the effectiveness of APC at a high power setting for the ablation of BE
in a multicenter trial. Methods: In 8 study centers, 60 patients (mean age 57, range
27-77; 47 male, 13 female) with endoscopic and histologically proven non-
neoplastic BE (length of BE 1-8 cm) were recruited for treatment by APC in
combination with esomeprazole. After baseline documentation by video endoscopy
(VE) plus chromoendoscopy with 0,5% methylene blue (MB) and four quadrant
biopsies (4QB) including the gastroesophageal transition zone, BE was treated by
repeated APC using a power setting of 90 W; the number of APC sessions was
restricted depending on the length of BE. During the treatment period, all patients
received esomeprazole 80 mg daily; 2 weeks after completion of treatment the
esomeprazole dose was reduced to 20 mg on demand daily or adapted to the result
of 24 h pH monitoring. Endoscopic examinations including VE, chromoendoscopy
with MB, and 4QB depending on pretreatment length of BE were performed
3 weeks, 6 and 12 months after completion of treatment. The effect of ablation was
classified either as complete remission (CR; complete macroscopic and microscopic
regression of BE), partial remission (macroscopic regression more than 50%
depending on pretreatment length of BE) or minor response (macroscopic
regression of BE less than 50%). Results: 51/60 recruited patients were treated
within the study. 3 patients were lost for follow-up (FU) after complications had
occurred. In 37 of 48 patients (77%) CR was achieved after a mean FU of 14 months
(range 12-32). To achieve complete ablation of BE (mean length 3,6 cm), a mean of
2,6 APC sessions (range 1-5) were used. Transient complications (chest pain, fever)
were noted in 9/51 patients (17,6%). Major complications (stricture formation,
bleeding, perforation) occurred in 5/51 patients (9,8%). Conclusions: The fact that
esophageal cancer incidence rate in non-neoplastic BE is low and the goal of
ablation treatment namely complete ablation of BE is not reached in all patients
together with the risk for morbidity due to ablation does not justify APC for ablation
of non-neoplastic BE.
S1180
Lower Esophageal Sphincter (LES) Hypertension Influences
Intraesophageal (ILP) and Upper Esophageal Sphincter (UES)
Pressures in Achalasic Patients
Michele Marchese, Cristiano Spada, Andrea Tringali, Pietro Familiari,
Lucio Petruzziello, Maria Elena Riccioni, Vincenzo Perri,
Massimiliano Mutignani, Guido Costamagna
Introduction: The diagnosis of achalasia is realized by manometry when absent and/
or incomplete LES relaxation and aperistalsis in the distal two-thirds of the
esophageal body was observed. Secondary findings are represented by elevated ILP
and UES hypertension. Aim of this study was to evaluate the correlation between
these two findings and elevated LES resting pressure. Methods: One-hundred-
thirty-one patients referred to our Institution from January 1994 to November 2004
with symptoms suggestive for esophageal achalasia were retrospectively evaluated.
All the patients previously undergone Upper GI endoscopy, and Rx Barium swallow,
and manometry confirmed the diagnosis. The patients were subdivided into two
groups: Group A: LES resting pressure whithin our normal range (9-32 mmHg);
Group B: LES resting pressure O32 mmHg. Stata 6 for Windows (Stata Corporation,
Texas, US) was used for all statistical analyses. Univariate analyses for discontinuous
variables were done with use of Student’s t test; categorical variables were
compared by use of c2
-tests and P ! 0.05 was considered to be statistically
significant. Results: All patients (mean age 45.7 years; range 11-83; 64 males,
67 females) complained dysphagia. One-hundred-eleven (84.7%) reported un-
digested food regurgitation, 104 (79.4%) retrosternal pain, 49 (37%) weight loss,
and 37 (28.2%) cough. Endoscopy showed fluid retention in 69 patients (52.7%),
and esophagitis was observed in 39 (29.8%). Rx Barium swallow revealed
esophageal dilation in 112 patients (85.5%). Hypertensive LES was identified in 105
patients (80.1%), incomplete and/or absent LES relaxation was found in all cases,
ILP was elevated in 53 patients (40.45%), and hypertensive UES was described in 31
(23.6%). In 14 patients (10.7%) esophageal manometry showed ‘‘vigorous’’ variant
of achalasia. In Group A, LES resting pressure was 28.6G2.6 mmHg (MeanGSD),
ILP was 0.48G3.3 mmHg (MeanGSD), and UES resting pressure was 67.5G37.7
(MeanGSD). In Group B, LES resting pressure was 45.7G12.8 mmHg (MeanGSD),
ILP was 7.7G7.6 mmHg (MeanGSD), and UES resting pressure was 86.7G46.2
(MeanGSD). Univariate analysis showed that in Group B ILP and hypertensive UES
were significantly higher (p!0.0005, and pZ0.03, respectively) when compared
with group A. Conclusions: Elevated ILP and hypertension of UES are important
features of manometric assessment in achalasia, and they are more frequent in
patients with elevated LES resting pressure.
Abstracts
AB136 GASTROINTESTINAL ENDOSCOPY Volume 61, No. 5 : 2005 www.mosby.com/gie