Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic <scp>GERD</scp>

Håkansson, Britt; Montgomery, Madeline C.; Cadière, Guy-Bernard; Rajan, Amin; Varannes, Stanislas Bruley des; Lerhun, Marc; Coron, Emmanuel; Tack, Jan; Bischops, R.; Thorell, Anders; Arnelo, Urban; Lundell, Lars

doi:10.1111/apt.13427

Cited by 97 publications

(81 citation statements)

References 35 publications

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“…One-hundred and twenty-nine patients were randomized at eight academic and community hospitals across the US (87 TIF 2.0/placebo and 42 sham/PPI). Patients with troublesome regurgitation despite daily PPI use with three validated GERD-specific symptom (9), was a multi-center, double-blind, shamcontrolled randomized trial comparing the efficacy of TIF 2.0 against a sham procedure in GERD patients who were chronic PPI users. The primary outcome was the time to 'treatment failure' during the first six months postintervention.…”

Section: Resultsmentioning

confidence: 99%

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials

Gerson¹,

Stouch²,

Lobonţiu³

2018

chr

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Introducere: Fundoplicatura transorală fără incizii (TIF) s-a dezvoltat ca o alternativă non-invazivă şi eficientă a tratamentului endoscopic al pacienţilor cu boala de reflux refractară tratamentului medical. Studiile anterioare sistematice sau metaanalize ale procedurii TIF a melanjat rezultate clinice din studii cu modalităţi care nu reflectă actuala şi recenta procedură TIF 2.0 dar nici selecţia riguroasă a pacienţilor bazata pe evidenţe obiective, clinice, validate anterior. Această metaanaliză a fost condusă şi designed utilizând datele clinice exclusiv a studiilor randomizate controlate care, pentru prima dată, au analizat noua tehnică TIF 2.0, procedura fiind comparată cu o cohorta de pacienţi control. Obiectivul acestei metaanalize constă în faptul ca determină eficacitatea clinică şi controlul simptomelor pe durată lungă postoperator al intervenţiei chirurgicale TIF 2.0 în exclusivitate la pacienţii care prezintă boala de reflux gastroesofagiană refractară la tratamentul optimizat cu inhibitori de pompă de protoni (IPP), incluzând rezultate obiective ca de exemplu pH-ul esofagian, administrarea de IPP şi calitatea vieţii a acestor pacienţi. Metodologie: Trei ipoteze de cercetare au fost analizate şi coroborate cu rezultatele clinice ale procedurii TIF 2.0, comparându-le cu pacienţii care au rămas sub tratament optimizat cu IPP, sau placebo, tratament concomitent al bolii de reflux şi calitatea vieţii raportată de pacienţi cu ajutorul questionarelor validate. Evenimentele descrise au fost calculate utilizând effectul randomizat.

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Section: Resultsmentioning

confidence: 99%

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials

Gerson¹,

Stouch²,

Lobonţiu³

2018

chr

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“…The TF procedure creates a full-thickness, partial esophagogastric fundoplication above the Z -line, with fastener fixations extending longitudinally up to 3.5 cm and circumferentially between 270° and 330° [11]. Published randomized controlled multicenter double-blind and open-label studies have demonstrated the superiority of the TF procedure as compared to high-dose PPI therapy and/or sham procedure in eliminating troublesome regurgitation and a range of classic and atypical manifestations of chronic GERD up to 12 months post-TF in subgroups of patients with hiatal hernias ≤2 cm [12–15]. Importantly, in more than 17,000 procedures performed to date, TF has maintained a solid safety record with virtual absence of associated new onset of dysphagia and gas bloat [12–15].…”

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confidence: 99%

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

et al. 2016

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BackgroundFour randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure.MethodsThe TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis.ResultsAt 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups.ConclusionThis study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

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“…EsophyX offers advantages over surgery [14][15][16][17], in particular the absence of incision and thus a faster remission, as well as fewer complications in the short and long term compared to the undesirable side effects associated with laparoscopic anti-reflux procedure compromising the results in some patients. Currently published literature suggests that incidence of persistent side effects after TIF is low [4][5][6]. This technique does not affect other future therapeutic options.…”

Section: Discussionmentioning

confidence: 91%

“…With no incision, no dissection and excellent safety profile, the procedure is performed with fewer complications than conventional ARS [5]. A novel device the EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Redmond, WA, USA) was designed to reconstruct a valve through tailored delivery of multiple fasteners during a single-device insertion [6,7]. This article presents results at 12 months from a prospective trial with 8 patients and was intended to further evaluate the safety and efficacy of the TIF procedure using the EsophyX system.…”

Section: Introductionmentioning

confidence: 99%

Evolution and Outcome of Eight Patients Undergoing Treatment of Gastroesophageal Disease by Esophyx

Abboud¹,

Khalek²

2017

J Gastrointest Dig Syst

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Background: Gastroesophageal reflux disease (GERD) is arguably the most common disease encountered by the gastroenterologist. It is mainly caused by defects in the lower esophageal sphincter (LES) that induces spontaneous transient LES relaxations (tLESRs). This is a chronic condition with typical and atypical, sometimes troublesome manifestations requiring long term treatment. Anti-reflux surgery is an alternative option. The TIF (transoral incisionless fundoplication) procedure by offering some advantages over surgery could be recommended for patients whose symptoms recur upon discontinuation of the medications. This study intended to assess the safety and efficacy of TIF for treating GERD.

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Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD

Cited by 97 publications

References 35 publications

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials

Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

Evolution and Outcome of Eight Patients Undergoing Treatment of Gastroesophageal Disease by Esophyx

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