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Twelve months' follow-up after treatment with the EndoCinch endoscopic technique for gastro-oesophageal reflux disease: a randomized, placebo-controlled study
Division of Surgery, CLINTEC, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm; Centre of Gastrointestinal Disease, Ersta Hospital, Stockholm.
Division of Surgery, CLINTEC, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm; Centre of Gastrointestinal Disease, Ersta Hospital, Stockholm.
Division of Surgery, CLINTEC, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm; Centre of Gastrointestinal Disease, Ersta Hospital, Stockholm.ORCID iD: 0000-0003-2636-4745
Division of Surgery, CLINTEC, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm; Centre of Gastrointestinal Disease, Ersta Hospital, Stockholm.
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2006 (English)In: Scandinavian Journal of Gastroenterology, ISSN 0036-5521, E-ISSN 1502-7708, Vol. 41, no 12, p. 1382-9Article in journal (Refereed) Published
Abstract [en]

Objective: The Bard EndoCinch plication technique has been reported to improve symptoms and reduce oesophageal acid exposure in patients with gastro-oesophageal reflux disease (GORD). However, no placebo-controlled studies have been published as yet. The purpose of this study was to evaluate the effects of the EndoCinch plication technique in a randomized, placebo-controlled setting.

Material and methods: Forty-six otherwise healthy subjects with objectively verified GORD requiring regular use of proton-pump inhibitors (PPIs) were enrolled in the study. Patients were randomized to the EndoCinch plication technique or a sham procedure. Pre- and post-procedure assessments included gastro-oesophageal endoscopy, oesophageal manometry and 24-h pH recording, quality of life (QoL) assessment and use of PPIs.

Results: Reflux-specific symptoms and use of PPIs (total intake as well as number of patients not taking PPIs) improved in both groups at 6 weeks and at 3 and 12 months post-procedure (p<0.05) with an increased improvement in the treatment group at 3 months compared to controls (p<0.05 versus sham). There were no inter- or intra-group differences in endoscopic findings, oesophageal manometry or acid exposure before or at 3 or 12 months post-procedure. Gastro-oesophageal endoscopy showed that 71% and 67% of sutures remained at 3 and 12 months, respectively.

Conclusions: Although some short-term effects were achieved, it was found that there were no differences between the treatment and control groups after 12 months and the lack of reduction of oesophageal acid exposure suggests that, in its present form, the EndoCinch plication technique is not to be recommended for use in clinical practice. It is suggested that the lack of long-term effects is primarily due to detachment of the sutures.

Place, publisher, year, edition, pages
Oslo, Norway: Taylor & Francis, 2006. Vol. 41, no 12, p. 1382-9
Keywords [en]
EndoCinch, endoscopic antireflux treatment, gastroplication, GORD
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:oru:diva-40363DOI: 10.1080/00365520600735738ISI: 000242103200002PubMedID: 17101568Scopus ID: 2-s2.0-33751119907OAI: oai:DiVA.org:oru-40363DiVA, id: diva2:777197
Available from: 2015-01-08 Created: 2015-01-08 Last updated: 2017-12-05Bibliographically approved

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