Benjamin Heimgartner, Stv. Oberarzt, Unversitätsklinik für Viszerale

Transcription

Journal club, 2015.02.04
Benjamin Heimgartner, Stv. Oberarzt, Unversitätsklinik für Viszerale Chirurgie und Medizin, Abteilung Gastroenterologie, Inselspital Bern
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Introduction
• ~ 40% GERD patients have troublesome
symptoms despite PPI therapy
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• Side effects of laparascopic fundoplication:
- dysphagia
- bloating
- inability to vomit
- diarrhea
=> Only < 10% patients are considered for surgery
=> Therapeutic gap between surgery
and medical treatment
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Methods
• Multicenter study in USA
• Adult patients with troublesome GERD symptoms
despite ≥ 40 mg PPI/d
• Symptom assesement with 3 questionnaires on
and off PPI
• Esophageal manometry
• Bravo capsule: distal esophageal pH <4 for >5.3%
• Cineesophagography: Hiatal hernia?
• Esophagogastroduodenoscopy
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Exclusion criteria
• Systemic disease, portal hypertension
• Obesity determined (BMI >35 kg/m2)
• Esophageal ulcer, stricture,
Barrett’s esophagus >2 cm, hiatal hernia >2 cm,
esophagitis LA C/D, peptic ulcer disease
• Esophageal dysmotility
• Upper GI-surgery
• Gastric outlet obstruction, gastroparesis
• Pregnancy
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:
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Transoral Fundoplicatio (TF)
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+ Endoscopy, Bravo capsule off PPI
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Primary endpoint (RDQ)
> 2/5
> 3/5
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Secondary outcomes
• Early failure (> 12 weeks)
• Control of intraesophageal pH/number of reflux
• Improvement of heartburn
• Healing of esophagitis
• Side effects
• Adverse event
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Results
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Procedure
• Hill grade 1 in 79 of 82 (96%) of patients
• Fundoplicatio range 200–340 degrees
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Early treatment failure
• Sham group (after 12 weeks):
15 of 42 patients (36%)
• Transoral Fundoplicatio (TF):
p < 0.05
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Troublesome symptoms
• sham group (6 months):
• Transoral Fundoplicatio (TF):
p < 0.05
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Symptom scores (RDQ)
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Symptom score (sham off PPI)
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Impedance pH-metry results
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Additional results
Esophagitis
• Out of 13 patients with esophagitis and TF
-> 10 healed (77%), 4 de novo esophagitis
• Out of 2 patients with esophagitis and PPI
-> 1 healed, 1 improved, 5 de novo esophagitis
Dysphagia and bloating improved in both groups
- Only 1 patient with de novo dysphagia in TF group
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Discussion
• TF seems to be safe and at least effective as PPI
in patients with partial or no response to PPI an
proven GERD an no hiatal hernia (NNT 6)
• No “long term” side effects in this study
• No superiority of symptom score compared
to PPI therapy
• No normalisation of distal esophageal acid
exposure
• Short follow up period (6 months)
• No comparison with laparoscopic fundoplication
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Benjamin Heimgartner, Stv. Oberarzt, Unversitätsklinik für Viszerale

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