Giovanni Zaninotto

Long-term results of the European achalasia trial: a multicentre randomised controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy.

Objective Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. Design 201 newly diagnosed patients with achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score ≤3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications. Results In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5u2005years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs 91% for PD, p=0.08, log-rank test). After 5u2005years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PD patients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM. Conclusions After at least 5u2005years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PD patients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for achalasia. Trial registration numbers Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564).

BOB CAT: a Large-Scale Review and Delphi Consensus for Management of Barrett’s Esophagus With No Dysplasia, Indefinite for, or Low-Grade Dysplasia

OBJECTIVES:Barrett’s esophagus (BE) is a common premalignant lesion for which surveillance is recommended. This strategy is limited by considerable variations in clinical practice. We conducted an international, multidisciplinary, systematic search and evidence-based review of BE and provided consensus recommendations for clinical use in patients with nondysplastic, indefinite, and low-grade dysplasia (LGD).METHODS:We defined the scope, proposed statements, and searched electronic databases, yielding 20,558 publications that were screened, selected online, and formed the evidence base. We used a Delphi consensus process, with an 80% agreement threshold, using GRADE (Grading of Recommendations Assessment, Development and Evaluation) to categorize the quality of evidence and strength of recommendations.RESULTS:In total, 80% of respondents agreed with 55 of 127 statements in the final voting rounds. Population endoscopic screening is not recommended and screening should target only very high-risk cases of males aged over 60 years with chronic uncontrolled reflux. A new international definition of BE was agreed upon. For any degree of dysplasia, at least two specialist gastrointestinal (GI) pathologists are required. Risk factors for cancer include male gender, length of BE, and central obesity. Endoscopic resection should be used for visible, nodular areas. Surveillance is not recommended for <5 years of life expectancy. Management strategies for indefinite dysplasia (IND) and LGD were identified, including a de-escalation strategy for lower-risk patients and escalation to intervention with follow-up for higher-risk patients.CONCLUSIONS:In this uniquely large consensus process in gastroenterology, we made key clinical recommendations for the escalation/de-escalation of BE in clinical practice. We made strong recommendations for the prioritization of future research.

EAES recommendations for the management of gastroesophageal reflux disease

BackgroundGastroesophageal reflux disease (GERD) is one of the most frequent benign disorders of the upper gastrointestinal tract. Management of GERD has always been controversial since modern medical therapy is very effective, but laparoscopic fundoplication is one of the few procedures that were quickly adapted to the minimal access technique. The purpose of this project was to analyze the current knowledge on GERD in regard to its pathophysiology, diagnostic assessment, medical therapy, and surgical therapy, and special circumstances such as GERD in children, Barrett’s esophagus, and enteroesophageal and duodenogastroesophageal reflux.MethodsThe European Association of Endoscopic Surgery (EAES) has tasked a group of experts, based on their clinical and scientific expertise in the field of GERD, to establish current guidelines in a consensus development conference. The expert panel was constituted in May 2012 and met in September 2012 and January 2013, followed by a Delphi process. Critical appraisal of the literature was accomplished. All articles were reviewed and classified according to the hierarchy of level of evidence and summarized in statements and recommendations, which were presented to the scientific community during the EAES yearly conference in a plenary session in Vienna 2013. A second Delphi process followed discussion in the plenary session.ResultsRecommendations for pathophysiologic and epidemiologic considerations, symptom evaluation, diagnostic workup, medical therapy, and surgical therapy are presented. Diagnostic evaluation and adequate selection of patients are the most important features for success of the current management of GERD. Laparoscopic fundoplication is the most important therapeutic technique for the success of surgical therapy of GERD.ConclusionsSince the background of GERD is multifactorial, the management of this disease requires a complex approach in diagnostic workup as well as for medical and surgical treatment. Laparoscopic fundoplication in well-selected patients is a successful therapeutic option.

Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis.

Peroral endoscopic myotomy (POEM) is a novel approach to performing esophageal myotomy for the treatment of achalasia. This review aims to assess subjective and objective metrics of achalasia treatment efficacy, perioperative adverse events and the incidence of postoperative gastroesophageal reflux disease in patients treated with POEM. Secondary aims include a pooled analysis comparison of the clinical outcomes and procedural safety of POEM versus laparoscopic Hellers myotomy (LHM). A systematic review of the literature, up to and including January 15, 2015, was conducted for studies reporting POEM outcomes. Studies comparing POEM to LHM were also included for the purpose of pooled analysis. Outcomes from 1122 POEM patients, from 22 studies, are reported in this systematic review. Minor operative adverse events included capno/pneumo-peritoneum (30.6%), capno/pneumo-thorax (11.0%) and subcutaneous emphysema (31.6%). Major operative adverse events included mediastinal leak (0.3%), postoperative bleeding (1.1%) and a single mortality (0.09%). There was an improvement in lower esophageal sphincter pressure and timed barium esophagram column height of 66% and 80% post-POEM, respectively. Symptom improvement was demonstrated with a pre- and post-POEM Eckardt score ± standard deviation of 6.8 ± 1.0 and 1.2 ± 0.6, respectively. Pre- and post-POEM endoscopy showed esophagitis in 0% and 19% of patients, respectively. The median (interquartile range) points scored for study quality was 15 (14-16) out of total of 32. Pooled analysis of three comparative studies between LHM and POEM showed similar results for adverse events, perforation rate, operative time and a nonsignificant trend toward a reduced length of hospital stay in the POEM group. In conclusion, POEM is a safe and effective treatment for achalasia, showing significant improvements in objective metrics and achalasia-related symptoms. Randomized comparative studies of LHM and POEM are required to determine the most effective treatment modality for achalasia.

Barrett's esophagus and adenocarcinoma risk: the experience of the North-Eastern Italian Registry (EBRA).

Objective:To establish the incidence and risk factors for progression to high-grade intraepithelial neoplasia (HG-IEN) or Barretts esophageal adenocarcinoma (BAc) in a prospective cohort of patients with esophageal intestinal metaplasia [(BE)]. Background:BE is associated with an increased risk of BAc unless cases are detected early by surveillance. No consistent data are available on the prevalence of BE-related cancer, the ideal surveillance schedule, or the risk factors for cancer. Methods:In 2003, a regional registry of BE patients was created in north-east Italy, establishing the related diagnostic criteria (endoscopic landmarks, biopsy protocol, histological classification) and timing of follow-up (tailored to histology) and recording patient outcomes. Thirteen centers were involved and audited yearly. The probability of progression to HG-IEN/BAc was calculated using the Kaplan-Meier method; the Cox regression model was used to calculate the risk of progression. Results:HG-IEN (10 cases) and EAc (7 cases) detected at the index endoscopy or in the first year of follow-up were considered to be cases of preexisting disease and excluded; 841 patients with at least 2 endoscopies {median, 3 [interquartile range (IQR): 2–4); median follow-up = 44.6 [IQR: 24.7–60.5] months; total 3083 patient-years} formed the study group [male/female = 646/195; median age, 60 (IQR: 51–68) years]. Twenty-two patients progressed to HG-IEN or BAc (incidence: 0.72 per 100 patient-years) after a median of 40.2 (26.9–50.4) months. At multivariate analysis, endoscopic abnormalities, that is, ulceration or nodularity (P = 0.0002; relative risk [RR] = 7.6; 95% confidence interval, 2.63–21.9), LG-IEN (P = 0.02, RR = 3.7; 95% confidence interval, 1.22–11.43), and BE length (P = 0.01; RR = 1.16; 95% confidence interval, 1.03–1.30) were associated with BE progression. Among the LG-IEN patients, the incidence of HG-IEN/EAc was 3.17 patient-years, that is, 6 times higher than in BE patients without LG-IEN. Conclusions:These results suggest that in the absence of intraepithelial neoplastic changes, BE carries a low risk of progression to HG-IEN/BAc, and strict surveillance (or ablative therapy) is advisable in cases with endoscopic abnormalities, LG-IEN or long BE segments.

Laparoscopic repair of hiatus hernia: Does mesh type influence outcome? A meta-analysis and European survey study

BackgroundSynthetic mesh (SM) has been used in the laparoscopic repair of hiatus hernia but remains controversial due to reports of complications, most notably esophageal erosion. Biological mesh (BM) has been proposed as an alternative to mitigate this risk. The aim of this study is to establish the incidence of complications, recurrence and revision surgery in patients following suture (SR), SM or BM repair and undertake a survey of surgeons to establish a perspective of current practice.MethodsAn electronic search of EMBASE, MEDLINE and Cochrane database was performed. Pooled odds ratios (PORs) were calculated for discrete variables. To survey current practice an online questionnaire was sent to emails registered to the European Association for Endoscopic Surgery.ResultsNine studies were included, comprising 676 patients (310 with SR, 214 with SM and 152 with BM). There was no significant difference in the incidence of complications with mesh compared to SR (Pxa0=xa00.993). Mesh significantly reduced overall recurrence rates compared to SR [14.5 vs. 24.5xa0%; PORxa0=xa00.36 (95xa0% CI 0.17–0.77); Pxa0=xa00.009]. Overall recurrence rates were reduced in the SM compared to BM groups (12.6 vs. 17.1xa0%), and similarly compared to the SR group, the POR for recurrence was lower in the SM group than the BM group [0.30 (95xa0% CI 0.12–0.73); Pxa0=xa00.008 vs. 0.69 (95xa0% CI 0.26–1.83); Pxa0=xa00.457]. Regarding surgical technique 503 survey responses were included. Mesh reinforcement of the crura was undertaken by 67xa0% of surgeons in all or selected cases with 67xa0% of these preferring synthetic mesh to absorbable mesh. One-fifth of the respondents had encountered mesh erosion in their career.ConclusionsBoth SM and BM reduce rates of recurrence compared to SR, with SM proving most effective. Surgical practice is varied, and there remains insufficient evidence regarding the optimum technique for the repair of hiatal hernia.

Diffuse esophageal spasm: the surgical approach

Diffuse esophageal spasm (DES) is a rare primary motility disorder of unknown cause, that can be found in patients complaining of chest pain and dysphagia and in whom ischemic heart disease and GERD have been excluded. The manometric hallmark of DES is the presence of simultaneous contractions in the distal esophagus alternating with a normal peristalsis. Even at specialized esophageal motility laboratories, DES is considered an uncommon diagnosis. In this review, the authors discuss the clinical and diagnostic aspects of this disease, as well as the possible therapeutic options (medical, endoscopic or surgical therapy). Surgery (esophageal myotomy performed through a thoracotomy or with a thoracoscopic access) seems to have a better outcome than medical or endoscopic treatment, and it is considered the last resource in these patients. However, satisfactory results are reported, from highly skilled centers, in only about 70% of treated cases, certainly inferior to those achieved in other esophageal disorders. The role of surgery in this disease requires therefore further study, even if controlled trials are probably difficult to perform, due to the rarity of the disease.

Complications after esophagectomy: it is time to speak the same language

It is unusual for the editors of a scientific journal to comment on an article published in another journal, but the study recently published in the Annals of Surgery by the Esophagectomy Complications Consensus Group (ECCG) entitled: ‘International Consensus on standardization of data collection for complications associated with esophagectomy’, deserves special attention. The ECCG involved 21 experienced surgeons from 14 countries and was supported by all the major thoracic and gastrointestinal societies, including the International Society for Diseases of the Esophagus (two of the group’s meetings were held during ISDE Congresses, bearing witness to the strong bond between the ECCG and our Society). It was also one of the first international consensus projects on esophageal disease to involve both thoracic and upper Gastro-Intestinal (GI) surgeons. By means of Delphi surveys and group meetings, the ECCG arrived at a consensus on a standard definition of the complications and quality measures to consider after esophagectomy, such as mortality, comorbidities, blood transfusion, grading of complication severity, changes in level of care, and readmission rates. Our journal is dedicated to esophageal diseases and receives 4 to 5 manuscripts a month on the topic of esophageal resections: the reporting and definition of complications is highly subjective and even the definition of such common surgical complications as anastomotic leak is not always consistent. This is not surprising: in a review of over 53 000 esophagectomies, Blencowe et al. found that less than 40% of the studies provided a precise definition of complications. Even mortality itself an apparently clear-cut event may be misleading because, if only 30-day mortality is reported, this may underestimate the real mortality by a factor of 4 compared with in-hospital mortality or 90-day mortality. The ECCG concluded that 30-day and in-hospital mortality should be reported, and 90-day mortality should preferably be recorded too. An extensive list of possible complications is given in the table 1 below (with permission from the Annals of Surgery). Other informations that should not be overlooked when reporting the outcome of esophagectomy are hospital readmissions, changes in level of care (i.e. returning to the Intensive Care Unit (ICU) or High Dependency Unit (HDU)), and destination on discharge (home or nursing/ rehabilitation facilities). A second fundamental issue addressed by the ECCG concerns the standardization of definitions of four common ‘surgical’ complications: anastomotic leak, conduit necrosis, chyle leak, and vocal cord palsy, as shown in the second table below (with permission from the Annals of Surgery). Adopting the definitions of the ECCG in future studies will enable us to draw meaningful comparisons among different surgical techniques and treatment approaches for esophageal cancer. Clearly, no definition is perfect, and some overlap may exist between different conditions, such as anastomotic leak and conduit necrosis. Nevertheless, the ECCG is the first to take a systematic approach to the consistent classification and definition of esophagectomy complications. The editors of Diseases of the Esophagus will do their best to encourage the use of this classification from now on for reporting the outcome of esophagectomy in our journal.

Practice Patterns and Outcomes After Hospital Admission With Acute Para-esophageal Hernia in England.

Objective: (i) To establish at a national level clinical outcomes from patients presenting with acute para-esophageal hernia (PEH); and (ii) to determine if a hospital volume-outcome relationship exists for the management of acute PEH. Background: Currently, no clear guidelines exist regarding the management of acute PEH, and practice patterns are based upon relatively small case series. Methods: Patients admitted as an emergency for the treatment of acute PEH between 1997 and 2012 were included from the Hospital Episode Statistics database. The influence of hospital volume upon clinical outcomes was analyzed in unmatched and matched comparisons to control for patient age, medical comorbidities, and incidence of PEH hernia gangrene. Results: Over the 16-year study period, 12,441 patients were admitted as an emergency with a PEH causing obstruction or gangrene. Of these, 90.8% patients were admitted with PEH with obstruction in the absence of gangrene and 9.2% with PEH with gangrene. The incidences of 30 and 90-day mortality were 7% and 11.5%, respectively, which did not decrease during the study period. Unmatched and matched comparisons showed, in high-volume centers, there were significant reductions in utilization of emergency surgery (8.8% vs 14.9%; P < 0.0001), 30-day (5.3% vs 7.8%; P < 0.0001), and 90-day mortality (9.3% vs 12.7%; P < 0.0001). Multivariate analysis also confirmed high hospital volume was independently associated with reduced 30 and 90-day mortality from acute PEH. Conclusions: Acute PEH represents a highly morbid condition, and treatment in high-volume centers provides the appropriate multidisciplinary infrastructure to manage these complex patients reducing associated mortality.

Shorter myotomy on the gastric site (≤2.5 cm) provides adequate relief of dysphagia in achalasia patients

The right length of the myotomy on the gastric side for esophageal achalasia is still a debated issue. We aimed to investigate the final outcome after classic myotomy (CM) as compared with a longer myotomy on the gastric side (LM) in two cohorts of achalasia patients. Forty-four achalasia patients who underwent laparoscopic Heller-Dor were considered; patients with a sigmoid-shaped esophagus were excluded. Symptoms were scored using a detailed questionnaire for dysphagia, regurgitation, and chest pain. Barium swallow, endoscopy, and esophageal manometry were performed before and 6 months after the surgical treatment; 24-hour pH-monitoring was also performed 6 months after the procedure. CM was defined as a gastric myotomy length in the range of 1.5-2.0u2009cm, while LM was 2.5-3u2009cm in length. The surgical treatment (CM or LM) was adopted in two consecutive cohorts. Treatment failure was defined as a postoperative symptom score >10th percentile of the preoperative score (i.e. >8). Of the 44 patients representing the study population, 20 had CM and 24 had LM. The patients demographic and clinical parameters (age, sex, symptom score, duration of symptoms, esophageal diameter, and manometric pattern) were similar in the two groups. The median follow up was 24 months (interquartile range 12-39). One patient in each group was classified as a treatment failure. After the treatment, there was a significant decrease in both groups symptom score, and resting and residual pressure (P < 0.01), with no statistically significant differences between the two groups in terms of postoperative symptom score, resting and residual pressure, or total and abdominal lower esophageal sphincter length and esophageal diameter. Extending the length of the myotomy on the gastric side does not seem to change the final outcome of the laparoscopic Heller-Dor procedure.