Society for Surgery of the Alimentary Tract

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The 3-Year Outcome of Optimal Medical Or Surgical Management of Gerd Patients with Barrett’S Esophagus: the Lotus Trial Experience
Stephen E. Attwood*1, Lars R. Lundell2, Jan G. Hatlebakk3, Stefan Eklund4, Ola Junghard4, Jean Paul Galmiche5, Christian Ell6, Roberto Fiocca7, Tore Lind4
1North Tyneside Hospital, North Shields, United Kingdom; 2Karolinska University Hospital Huddinge, Stockholm, Sweden; 3Haukeland Hospital, Bergen, Norway; 4AstraZeneca R&D, Mölndal, Sweden; 5Hotel Dieu-CHU de Nantes, Nantes, France; 6Dr.-Horst-Schmidt-Kliniken Wiesbaden, Wiesbaden, Germany; 7University of Genova, Genova, Italy

Introduction: The long-term management of gastroesophageal reflux disease (GERD) in patients with Barrett’s esophagus (BE) is not well supported by an evidence-based consensus. In patients with BE, standard doses of acid-suppression therapy often result in incomplete reflux control, both symptomatically and as measured by pH monitoring. Similarly, the outcomes of anti-reflux surgery reported in the literature have been poor. This analysis aimed to compare the long-term outcome of optimal medical vs surgical anti-reflux treatment in patients with BE (biopsy-proven intestinal metaplasia). A secondary aim was to identify if there were any differences in treatment outcome comparing patients with and without BE.
Methods: In the LOTUS trial (a European multicenter randomized study; ClinicalTrials.gov identifier: NCT00251927), standardized laparoscopic anti-reflux surgery (LARS) was compared with dose-adjusted medical therapy, starting with esomeprazole 20mg od (ESO), and increasing if needed to 20mg bd. Operative difficulty, complications, pre- and post-treatment symptoms (GSRS), time to treatment failure (ie, need for alternative therapy), pre- and post-treatment measurements of esophageal acid exposure (after 6 months) and endoscopic findings (at 3 years) are reported.
Results: Out of 554 patients with chronic GERD, 60 patients had BE of whom 28 were randomized to medical treatment and 32 to LARS. The median acid exposure times before treatment were not significantly different in patients with or without BE. Before surgical treatment, patients with BE had acid with pH<4 in their esophagus for 13.2% of the time, which reduced to 0.4% 6 months after surgery. The corresponding figures for medically treated patients were 7.4% and 4.9%. Operative difficulty was greater in patients with BE (23% vs 13% in patients with no BE). This was based on a longer operating time (30% >2 hrs vs 23% in non-BE), and larger hiatus hernias (37% >5cm vs 15% in non-BE) requiring >3 crural sutures in 40% BE vs 28% non-BE. There was no apparent difference between the groups in post-operative complications. The GSRS scores of patients were similar for the medically and surgically treated groups, regardless of the presence or absence of BE, both at baseline and at 3 years. Three BE patients in the medically treated group and one in the surgically treated group were judged to be treatment failures at 3 years.
Conclusion: There is a high degree of success at 3 years with optimal medical or surgical anti-reflux therapy. In a well-controlled surgical environment, the success of LARS in patients with BE is greater than expected and similar to that in patients without BE.


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