[Surgical and interventional procedures for reflux therapy : Endoscopic or laparoscopic?] / Operative/interventionelle Verfahren zur Refluxtherapie : Endoskopisch oder laparoskopisch?

An optimal functioning of the gastroesophageal antireflux barrier depends on an anatomical overlapping of the lower esophageal sphincter and the crural diaphragm. Restoration of this situation is currently only possible by antireflux interventions combined with hiatoplasty and necessitates a laparoscopic approach. Newer alternative techniques to the generally accepted fundoplication are laparoscopic implantation of the LINX® device or the EndoStim® system and various endoscopic antireflux procedures, such as radiofrequency energy treatment, plication and implantation techniques aimed at augmentation of the gastroesophageal valve. Endoscopic techniques are becoming established more and more between pharmaceutical and surgical therapy instead of replacing them.

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

BACKGROUND: Until recently only two therapeutic options have been available to control symptoms and the esophagitis in chronic gastro-oesophageal reflux disease (GERD), i.e. lifelong proton pump inhibitor (PPI) therapy or anti-reflux surgery. Lately, transoral incisionless fundoplication (TIF) has been developed and found to offer a therapeutic alternative for these patients. AIM: To perform a double-blind sham-controlled study in GERD patients who were chronic PPI users. METHODS: We studied patients with objectively confirmed GERD and persistent moderate to severe GERD symptoms without PPI therapy. Of 121 patients screened, we finally randomised 44 patients with 22 patients in each group. Those allocated to TIF had the TIF2 procedure completed during general anaesthesia by the EsophyX device with SerosaFuse fasteners. The sham procedure consisted of upper GI endoscopy under general anaesthesia. Neither the patient nor the assessor was aware of the patients' group affiliation. The primary effectiveness endpoint was the proportion of patients in clinical remission after 6-month follow-up. Secondary outcomes were: PPI consumption, oesophageal acid exposure, reduction in Quality of Life in Reflux and Dyspepsia and Gastrointestinal Symptom Rating Scale scores and healing of reflux esophagitis. RESULTS: The time (average days) in remission offered by the TIF2 procedure (197) was significantly longer compared to those submitted to the sham intervention (107), P < 0.001. After 6 months 13/22 (59%) of the chronic GERD patients remained in clinical remission after the active intervention. Likewise, the secondary outcome measures were all in favour of the TIF2 procedure. No safety issues were raised. CONCLUSION: Transoral incisionless fundoplication (TIF2) is effective in chronic PPI-dependent GERD patients when followed up for 6 months. Clinicaltrials.gov: CT01110811.

Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial.

BACKGROUND: Both long-term proton pump inhibitor (PPI) use and surgical fundoplication have potential drawbacks as treatments for chronic gastroesophageal reflux disease (GERD). This multi-center, prospective study evaluated the clinical experiences of 69 patients who received an alternative treatment: endoscopic anterior fundoplication with a video- and ultrasound-guided transoral surgical stapler. METHODS: Patients with well-categorized GERD were enrolled at six international sites. Efficacy data was compared at baseline and at 6 months post-procedure. The primary endpoint was a ≥ 50 % improvement in GERD health-related quality of life (HRQL) score. Secondary endpoints were elimination or ≥ 50 % reduction in dose of PPI medication and reduction of total acid exposure on esophageal pH probe monitoring. A safety evaluation was performed at time 0 and weeks 1, 4, 12, and 6 months. RESULTS: 66 patients completed follow-up. Six months after the procedure, the GERD-HRQL score improved by >50 % off PPI in 73 % (48/66) of patients (95 % CI 60-83 %). Forty-two patients (64.6 %) were no longer using daily PPI medication. Of the 23 patients who continued to take PPI following the procedure, 13 (56.5 %) reported a ≥ 50 % reduction in dose. The mean percent of total time with esophageal pH <4.0 decreased from baseline to 6 months (P < 0.001). Common adverse events were peri-operative chest discomfort and sore throat. Two severe adverse events requiring intervention occurred in the first 24 subjects, no further esophageal injury or leaks were reported in the remaining 48 enrolled subjects. CONCLUSIONS: The initial 6-month data reported in this study demonstrate safety and efficacy of this endoscopic plication device. Early experience with the device necessitated procedure and device changes to improve safety, with improved results in the later portion of the study. Continued assessment of durability and safety are ongoing in a three-year follow-up study of this patient group.

Endoscopic full-thickness plication versus laparoscopic fundoplication: a prospective study on quality of life and symptom control.

BACKGROUND: Endoscopic antireflux techniques have emerged as alternative therapies for gastroesophageal reflux disease (GERD). Endoscopic plication receives continuing interest as an effective and safe procedure. This treatment option has not been the subject of comparison with well-established operative therapies to date. The present study aimed at comparatively evaluating the effectiveness of endoscopic plication and laparoscopic fundoplication in terms of quality of life and symptom control. METHODS: Between October 2006 and April 2010, 60 patients with documented GERD were randomly assigned to undergo either endoscopic plication or laparoscopic fundoplication. Quality-of-life scores and symptom grading were recorded before treatment and at 3- and 12-month follow-up. Outcomes were compared with the statistical significance set at a p value of 0.05. RESULTS: Twenty-nine patients from the endoscopic group and 27 patients from the operative group were available at follow-up. Quality-of-life scores showed a substantial and similar increase for both groups after treatment. Symptoms of heartburn (p < 0.02), regurgitation (p < 0.004), and asthma (p = 0.03) were significantly improved in the endoscopic group, whereas laparoscopic fundoplication was more effective in controlling symptoms of heartburn (p < 0.01) and regurgitation (p < 0.05) compared to the endoscopic procedure. CONCLUSIONS: Endoscopic plication and laparoscopic fundoplication resulted in significant symptom improvement with similar quality-of-life scores in a selected patient population with GERD, whereas operative treatment was more effective in the relief of heartburn and regurgitation at the expense of higher short-term dysphagia rates.

Laparoscopic esophagomyotomy and antireflux procedure with intraoperative manometry.

We have been routinely performing laparoscopic cholecystectomy and antireflux procedures. Having this experience, we decided to assess the feasibility and safety of performing a laparoscopic esophagomyotomy and antireflux procedure. Here we present a case of a 37-year-old man with a history of progressive dysphagia and a diagnosis of achalasia, made on the basis of clinical, endoscopic, and manometric studies. Preoperative manometry reported a pressure of 52 mm Hg (normal, 15-25 mm Hg) for 4.5 cm (normal, > 3 cm). Laparoscopic esophagomyotomy and anterior fundoplication were performed. The esophagomyotomy included a 6-cm segment of distal esophagus and 2 cm of stomach; postoperative manometry was 18 mm Hg for 3 cm. Eight months postoperatively, a barium swallow demonstrated no reflux. Laparoscopic esophagomyotomy and antireflux procedure can be performed with efficacy and safety, with the advantage of a shorter hospitalization and an early recovery compared with the traditional procedure. Also, we emphasize the importance of the intraoperative manometry in the relevance of a concomitant antireflux procedure.