PMID- 19185691
OWN - NLM
STAT- MEDLINE
DCOM- 20090526
LR  - 20131121
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 69
IP  - 2
DP  - 2009 Feb
TI  - A new injectable agent for the treatment of GERD: results of the Durasphere pilot 
      trial.
PG  - 318-23
LID - 10.1016/j.gie.2008.07.034 [doi]
AB  - BACKGROUND: A variety of endoscopic modalities have been introduced to treat 
      GERD, including radiofrequency energy, suturing, plication, and injection 
      therapy. OBJECTIVE: Our purpose was to assess the long-term safety and 
      effectiveness of Durasphere (Carbon Medical Technologies, St Paul, Minn), a new 
      injectable bulking agent, in the treatment of mild-moderate GERD. DESIGN: Initial 
      human pilot study. SETTING: Single endoscopy center; study period from January 
      2005 to August 2006. PATIENTS: Ten GERD subjects, confirmed by pH monitoring, on 
      daily proton pump inhibitor (PPI) therapy, hiatal hernia <3 cm, and no or mild 
      erosive esophagitis. INTERVENTION: Endoscopic injection with Durasphere, a new 
      submucosal bulking agent, at the gastroesophageal junction. OUTCOMES: Change in 
      symptom scores, PPI use, pH scores, and endoscopic findings; monitoring of safety 
      profile. RESULTS: Nine of 10 patients completed the 12-month trial. There were no 
      adverse events. The procedure was well tolerated with minimal patient discomfort 
      and no dysphagia. At 12 months 70% of patients discontinued all antacid 
      medication completely; 90% of patients reduced PPI use by greater than 50%. 
      DeMeester scores improved from a mean of 44.5 at baseline to 26.5 at 12 months; 4 
      patients achieved normal pH scores. There was no esophagitis at 12 months, and no 
      erosion, ulceration or sloughing of material was noted at any injection site. The 
      Durasphere material did not appear to migrate. LIMITATIONS: Nonrandomized study 
      design without a control group; small number of subjects. CONCLUSIONS: Durasphere 
      appears to be a promising new injectable bulking agent for the treatment of 
      mild-moderate GERD, with demonstrable efficacy and no significant adverse events 
      in a small cohort.
FAU - Ganz, Robert A
AU  - Ganz RA
AD  - Current affiliations: Minnesota Gastroenterology, Plymouth, Minnesota 55446, USA. 
      gastrodude@visi.com
FAU - Fallon, Elizabeth
AU  - Fallon E
FAU - Wittchow, Tina
AU  - Wittchow T
FAU - Klein, Dean
AU  - Klein D
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Glucans)
RN  - 0 (durasphere)
RN  - C6V6S92N3C (Zirconium)
SB  - IM
CIN - Gastrointest Endosc. 2009 Feb;69(2):324-6. PMID: 19185692
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Esophagoscopy
MH  - Female
MH  - Gastric Acidity Determination
MH  - Gastroesophageal Reflux/*drug therapy
MH  - Glucans/*administration & dosage/therapeutic use
MH  - Humans
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Treatment Outcome
MH  - Zirconium/*administration & dosage/therapeutic use
EDAT- 2009/02/03 09:00
MHDA- 2009/05/27 09:00
CRDT- 2009/02/03 09:00
PHST- 2008/02/13 00:00 [received]
PHST- 2008/07/13 00:00 [accepted]
PHST- 2009/02/03 09:00 [entrez]
PHST- 2009/02/03 09:00 [pubmed]
PHST- 2009/05/27 09:00 [medline]
AID - S0016-5107(08)02325-0 [pii]
AID - 10.1016/j.gie.2008.07.034 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2009 Feb;69(2):318-23. doi: 10.1016/j.gie.2008.07.034.