Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study

BMC Gastroenterology

Peter George Mavrelis³  Mark Alan Fox¹  Daniel Gilles Turgeon⁶  Jeffrey Alan Heise²  Mamoon Raza⁴  Ahmad Bassel Shughoury³  William Edris Barnes⁷  Gilbert Simoni⁵  Karim Sami Trad⁶ 

[1] Department of Surgery, Cumberland Medical Center, Crossville, TN, USA;Heartburn Center/Rehabilitation Department, Hancock Regional Hospital, Greenfield, IN, USA;Internal Medicine Associates, Merrillville, IN, USA;Department of Gastroenterology, Unity Surgical Hospital, Mishawaka, IN, USA;Advanced Gastroenterology, Inc., Thousand Oaks, CA, USA;Reston Surgical Associates, Reston, VA, USA;Department of Surgery, Livingston Hospital and Healthcare Services, Inc. CAH, Salem, KY, USA

关键词: Regurgitation;    Atypical GERD symptoms;    EsophyX;    TIF;   

Others  :  1121791
DOI  :  10.1186/1471-230X-14-174

 received in 2014-08-07, accepted in 2014-10-03,  发布年份 2014

【 摘 要 】

Background

The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF.

Methods

In seven United States centers, patients with hiatal hernia ≤2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar’s test or Fisher exact test was used to compare proportions.

Results

Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE.

Conclusions

The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up.

Trail registration

Clinicaltrials.gov: NCT01647958.

【 授权许可】

   
2014 Trad et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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