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Peroral endoscopic myotomy (POEM) for oesophageal achalasia: Preliminary results in humans

BACKGROUND Peroral endoscopic myotomy has been developed to provide a less invasive treatment for oesophageal achalasia compared to surgical cardiomyotomy. AIMS To report our initial experience on feasibility, safety and clinical efficacy of peroral endoscopic myotomy. METHODS Eleven patients (eight women, mean age 32, range 24-58) underwent an attempt at peroral endoscopic myotomy under general anaesthesia. After submucosal injection, a mucosal entry into the oesophageal submucosa, and a tunnel extending to the oesophagogastric junction and beyond into the stomach were created (total mean length: 15 ± 1.7 cm). Myotomy of the circular oesophageal and gastric muscle bundles was then achieved under direct vision (total mean length: 10.2 ± 2.8 cm). Haemostatic clips were used to close the mucosal entry. The Eckardt Score and manometry were used to evaluate the results. RESULTS Peroral endoscopic myotomy could be completed in 10 out of 11 patients (91%). Mean procedure time was 100.7 min (range 75-140 min). No major complication occurred. Clinical success was achieved in all patients at 1-month follow-up (Eckardt Score 7.1 vs. 1.1, p=0). Lower oesophageal sphincter pressure decreased from 45.1 to 16.9 mm Hg (p=0). CONCLUSIONS This initial experience with peroral endoscopic myotomy shows its safety and efficacy in the treatment of achalasia. Further studies are warranted to assess the long-term efficacy and to compare peroral endoscopic myotomy with other treatment modalities.

Clinical response to peroral endoscopic myotomy in patients with idiopathic achalasia at a minimum follow-up of 2 years

Background The recently developed technique for peroral endoscopic myotomy (POEM) has been shown to be effective in several short-term studies. Longer term outcome data are largely non-existent. Objective To systematically report clinical outcome with a minimum post-POEM follow-up of 2 years. Design All patients treated consecutively by POEM for achalasia at three centres were retrospectively analysed, with a minimum follow-up of 2 years. The main outcome was the rate of POEM failures (Eckardt score >3) related to follow-up time. Results Of 85 patients treated, five (5.9%) cases were excluded due to protocol violation or loss to follow-up; the remaining 80 patients (mean age 44.9 years, 54% men) were followed clinically for 29 months (range 24–41). Initial clinical response was observed in 77 cases (96.3%). Clinical recurrences (later failures) were seen in a further 14 cases (17.7%), accounting for a total failure rate of 21.5%. In a multivariate analysis, age and endoscopic reflux signs were independent predictors of treatment success. Of the 17 failures, eight were among the first 10 cases treated in the participating centres. Reflux-associated sequelae included one case of a severe reflux-associated stricture requiring dilatation, and two patients with minor transient Eckardt score elevations curable by proton pump inhibitor (PPI) treatment. Endoscopic signs of reflux oesophagitis, mostly Los Angeles grade A/B, were seen in 37.5% (37/72) at the 2-year control. Conclusions In this multicentre retrospective analysis, a high initial success rate of POEM is followed by a mid-term recurrence rate of 18%. Reflux oesophagitis, albeit mild, is frequent and should probably be treated by regular low-dose PPI therapy. Trial registration number NCT 01405417 (UKE study).

Peroral Endoscopic Myotomy for Esophageal Achalasia: Outcomes of the First 100 Patients With Short-term Follow-up

OBJECTIVE Aim of this study is to report the mid-term outcomes of a large series of patients treated with peroral endoscopic myotomy (POEM) in a single European center. BACKGROUND POEM is a recently developed treatment of achalasia, which combines the efficacy of surgical myotomy, with the benefits of an endoscopic procedure. Previous studies, including few patients with a short-term follow-up, showed excellent results on dysphagia relief. METHODS The first 100 adult patients treated in a single tertiary referral center were retrospectively identified and included in this study (41 men, mean age 48.4 years). Patients were treated according to a standard technique. Follow-up data, including clinical evaluation, and results of esophagogastroduodenoscopy (EGD), manometry, and pH monitoring were collected and analyzed. RESULTS POEM was completed in 94% of patients. Mean operative time was 83 minutes (49-140  minutes). No complications occurred. Patients were fed after a median of 2 days (1-4 days). A mean follow-up of 11 months (3-24 months) was available for 92 patients. Clinical success was documented in 94.5% of patients. Twenty-four-hour pH monitoring documented Gastro-Esophageal Reflux Disease (GERD) in 53.4% of patients. However, only a minority of patients had heartburn (24.3%) or esophagitis (27.4%), and these patients were successfully treated with proton-pump inhibitors. CONCLUSIONS Our results confirm the efficacy of POEM in a large series of patients, with a mean follow-up of 11 months. Should our results be confirmed by long-term follow-up studies, POEM may become one of the first-line therapies of achalasia in the next future.

Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology (UEG) have identified quality of endoscopy as a major priority and we described our rationale for this in a first manuscript that also addressed the methodology of the quality initiative process.1 The identification of upper gastrointestinal (UGI) performance measures presents a considerable challenge, in contrast to the situation with colonoscopy for instance, where several performance measures (inspection time, adenoma detection rate, and interval cancers, among others) have been identified over the last decade.2,3 Following the Quality in UGI Endoscopy meeting held in Lisbon in 2013, it was clear that there was a need to identify performance measures for the UGI tract, and that quality standards could be identified although there is a paucity of evidence. This lack of evidence helps however to identify research priorities for the development of clinical trials that will further validate and substantiate the implementation of performance measures. The aim therefore of the UGI working group was twofold: (a) to identify performance measures for UGI endoscopy; (b) to identify the evidence or absence of evidence that would develop the research priorities in this field. We used an innovative methodology to facilitate the quality initiative process, which combined a thorough search and standardized evaluation of the available evidence for each clinical question, followed by a Delphi process (http://is.njit.edu/pubs/delphibook/delphibook.pdf) using an online platform.4,5 This online platform permitted iterative rounds of modification and comment by all members of the UGI working group until agreement was reached on the performance measure. We now report these newly identified performance measures.

Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule

Goals To assess the safety of the Pillcam in patients with known or suspected radiologic stricture, previously tested for small bowel patency using the Given Patency capsule. Background Intestinal stricture contributes a major contraindication to video capsule endoscopy (VCE), because of the risk of capsule retention. Study Twenty-seven patients (16 female, mean age 44.2 y) with known or suspected intestinal stricture were enrolled prospectively. Twenty-four had Crohns disease, 2 had adhesive syndrome and 1 had a suspected ischemic stricture. Patients underwent the Patency capsule test. In patients in whom the Patency capsule was excreted intact within 72 hours postingestion without occurrence of any adverse event, VCE was performed to assess the presence of strictures or other gastrointestinal pathologies. The following parameters were evaluated: transit time of Patency capsules and/or tags from ingestion to excretion, condition of the Patency capsule at excretion, transit time of the Pillcam capsule, the ability of Pillcam capsule to detect intestinal strictures and small bowel pathologies, any adverse events. Results Twenty-five patients (92.6%) retrieved the Patency capsule in the stools. Six patients complained of abdominal pain, 4 of whom excreted a nonintact capsule. Hospitalization was required in 1 (4.3%) patient with Crohns disease due to occlusive syndrome. Fifteen patients (65.3%) excreted an intact Patency capsule after a mean transit time of 25.6 hours without any adverse events. These 15 patients underwent the VCE successfully. Conclusions Passage of an intact Patency capsule across a small bowel stricture provides direct evidence of functional patency of the gut lumen and allows a safe VCE. Intestinal strictures should not be considered an absolute contraindication for VCE.

Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome

BACKGROUND Bariatric surgery is associated with specific complications and mortality. Transoral gastroplasty (TOGA) is a transoral restrictive bariatric procedure that might offer the benefits of surgery with a reduced complication rate. OBJECTIVE To evaluate the safety and efficacy of TOGA at 12-month follow-up. DESIGN Prospective, multicenter, single-arm trial. SETTING Two tertiary-care referral medical centers. PATIENTS This study involved 67 patients (average age 41.0 years, 47 women, baseline body mass index [BMI] 41.5 kg/m(2); 20 patients with BMI <40). INTERVENTION The TOGA procedures were performed by using 2 stapling devices that were used to create a small, restrictive pouch along the lesser gastric curvature. The pouch is designed to give the patient a sustained feeling of satiety after small meals. MAIN OUTCOME MEASUREMENTS Excess weight loss, excess BMI loss, safety, and improvements in quality of life, obesity-related comorbidities, and medication use. RESULTS Fifty-three patients were available at the 12-month follow-up. Excess BMI loss was 33.9%, 42.6%, and 44.8% at 3, 6, and 12 months, respectively. At 12 months, excess BMI loss was 52.2% for patients with a baseline BMI of <40.0 and 41.3% for patients with a baseline BMI of ≥ 40.0 (P < .05). At 12 months, hemoglobin A(1c) levels decreased from 7.0% at baseline to 5.7% (P = .01); triglyceride levels decreased from 142.9 mg/dL to 98 mg/dL (P < .0001); high-density lipoprotein levels increased from 47.0 mg/dL to 57.5 mg/dL (P < .0001). Two complications occurred: a case of respiratory insufficiency and an asymptomatic pneumoperitoneum treated conservatively. LIMITATIONS Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up. CONCLUSION The TOGA procedure allowed a substantial weight loss 1 year after the operation without severe complications. A long-term evaluation is needed before definitive conclusions can be drawn.

Peroral Endoscopic Myotomy for the Treatment of Achalasia in Children

ABSTRACT Peroral endoscopic myotomy (POEM) is a new endoscopic technique for the treatment of esophageal achalasia, with excellent results in adults. Three children with classic-type achalasia (mean age 9.6 years) underwent POEM in a single center. Mean basal lower esophageal sphincter pressure and Eckard score were 34.6 mmHg and 5.3, respectively. Mean length of myotomy was 10 cm. On average, POEM was completed in 60.6 minutes. No patients experienced postoperative complications or gastroesophageal reflux disease. In the 2 patients who completed a 12-month follow-up, complete symptoms relief was documented (Eckard score 0), as well as a significant drop of the basal lower esophageal sphincter pressure.

Endoscopic gallbladder drainage for acute cholecystitis: technical and clinical results

BACKGROUND AND STUDY AIMS Cholecystectomy is the standard treatment for acute cholecystitis while percutaneous drainage is reserved for high-risk patients. The aim of the present study was to assess the technical success rate and clinical efficacy of endoscopic gallbladder drainage in patients with acute cholecystitis. PATIENTS AND METHODS A total of 35 consecutive patients with acute cholecystitis and without residual common bile duct obstruction were retrospectively identified. Patients were stratified according to the pathogenesis and stages of acute cholecystitis, and the morphology of the cystic duct and/or its insertion in the common bile duct. Primary outcomes were technical success and early and late clinical success. RESULTS Endoscopic retrograde cholangiopancreatography (ERCP) was performed within the first 72 hours in 19 patients (54%). Technical success was achieved in 29 patients (83%); drainage was nasocholecystic in 21 of these (72%), plastic stenting in 6 (21%), and a combined method in 2 (7%). The pathogenesis and stage of acute cholecystitis, and the morphology both of the cystic duct and its insertion in the common bile duct, did not influence technical success. Clinical success was achieved in 24 cases (83%) after a median of 3 days (range 2-12). Four patients (14%) died within 3 days due to septic complications, and one accidentally removed the nasocholecystic drain after 24 hours. Late results, available in 21 patients after a median follow-up of 17 months, showed relapse of acute cholecystitis in 2 (10%) (both with stents) and of biliary pain in 2 patients (10%), both of whom had nasocholecystic drainage. CONCLUSIONS Endoscopic gallbladder drainage seems feasible and effective in resolving acute cholecystitis, but only as a temporary measure because of a 20% relapse rate in long-term follow-up. Prospective studies are necessary to identify which patients would benefit most from this endoscopic technique in the short and long term.

Gastroesophageal reflux disease after peroral endoscopic myotomy: Analysis of clinical, procedural and functional factors, associated with gastroesophageal reflux disease and esophagitis.

Peroral endoscopic myotomy (POEM) does not include any antireflux procedure, resulting in a certain risk of iatrogenic gastroesophageal reflux disease (GERD). The aim of the present study was to evaluate the incidence of iatrogenic GERD after POEM and identify preoperative, perioperative and postoperative factors associated with GERD.

EndoFLIP system for the intraoperative evaluation of peroral endoscopic myotomy

Background Peroral endoscopic myotomy (POEM) has been recently introduced in clinical practice for the treatment of achalasia. The endoluminal functional lumen imaging probe (EndoFLIP) system) uses impedance planimetry for the real-time measurement of the diameter of the oesophago-gastric junction. Objective The aim of this study is to prospectively evaluate the effect of POEM on the oesophago-gastric junction using EndoFLIP. Methods All the patients who underwent POEM in a single centre between April and July 2013 were enrolled in the study. EndoFLIP was used intraoperatively, immediately before and after POEM. During follow-up patients underwent oesophagogastroduodenoscopy, oesophageal pH monitoring and manometry. Clinical outcomes were compared with the diameter of the oesophago-gastric junction after POEM. Results In total, 23 patients (12 males, mean age 51.7 years) were enrolled, and 21 underwent POEM successfully. Preoperative mean basal lower oesophageal sphincter pressure was 42.1 mmHg (±17.6). Before POEM, the mean oesophago-gastric junction diameter and cross-sectional area were 6.3 mm (±1.8) and 32.9 mm2 (±23.1), respectively. After treatment, the mean diameter and cross-sectional area of the oesophago-gastric junction were 11.3 mm (±1.7 SD) and 102.38 mm2 (±28.2 SD), respectively. No complications occurred during a mean follow-up of 5 months. Median post-operative Eckardt score was 1. Three patients (14.3%) referred heartburn. Follow-up studies revealed gastro-oesophageal reflux disease (GORD) in 57.1% of patients and oesophagitis in 33.3%. No correlations were observed between the diameter of oesophago-gastric junction after POEM and symptoms relief, GORD incidence and lower oesophageal sphincter pressure. Conclusions The diameter of oesophago-gastric junction substantially increases after POEM. EndoFLIP is a reliable method for the intraoperative evaluation of oesophago-gastric junction diameter. However, the real usefulness of this technology after POEM remains controversial.