Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).

BACKGROUND: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. OBJECTIVE: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. METHODS: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists. RESULTS: The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life. CONCLUSIONS: This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.

Endoscopic management of gastrointestinal motility disorders - part 1: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

ESGE recommends the use of a graded pneumatic dilation protocol in achalasia, starting with a 30-mm dilation and followed by a 35-mm dilation at a planned interval of 2 - 4 weeks, with a subsequent 40-mm dilation when there is insufficient relief, over both a single balloon dilation procedure or the use of a larger balloon from the outset.Strong recommendation, high quality of evidence, level of agreement 100 %.ESGE recommends being cautious in treating spastic motility disorders other than achalasia with peroral endoscopic myotomy (POEM).Strong recommendation, very low quality of evidence, level of agreement 87.5 %.ESGE recommends against the routine use of botulinum toxin injections to treat patients with non-achalasia hypercontractile esophageal motility disorders (Jackhammer esophagus, distal esophageal spasm). However, if, in individual patients, endoscopic injection of botulinum toxin is chosen, ESGE recommends performing injections into four quadrants of the lower esophageal sphincter and in the lower third of the esophagus.Strong recommendation, low quality of evidence, level of agreement 78.6 %.ESGE recommends that endoscopic pylorus-directed therapy should be considered only in patients with symptoms suggestive of gastroparesis in combination with objective proof of delayed gastric emptying using a validated test, and only when medical therapy has failed.Strong recommendation, very low quality of evidence, level of agreement 100 %.ESGE recommends against the use of botulinum toxin injection in the treatment of unselected patients with gastroparesis. Strong recommendation, high quality of evidence, level of agreement 92.9 %.ESGE recommends consideration of gastric peroral endoscopic myotomy (G-POEM) in carefully selected patients only, because it is an emerging procedure with limited data on effectiveness, safety, and durability. G-POEM should be performed in expert centers only, preferably in the context of a clinical trial.Strong recommendation, low quality of evidence, level of agreement 100 %.

Endoscopic management of gastrointestinal motility disorders - part 2: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

ESGE suggests flexible endoscopic treatment over open surgical treatment as first-line therapy for patients with a symptomatic Zenker's diverticulum of any size.Weak recommendation, low quality of evidence, level of agreement 100 %.ESGE recommends that emerging treatments for Zenker's diverticulum, such as Zenker's peroral endoscopic myotomy (Z-POEM) and tunneling, be considered as experimental; these treatments should be offered in a research setting only.Strong recommendation, low quality of evidence, level of agreement 100 %.ESGE recommends against the widespread clinical use of transoral incisionless fundoplication (TIF) as an alternative to proton pump inhibitor (PPI) therapy or antireflux surgery in the treatment of gastroesophageal reflux disease (GERD), because of the lack of data on the long-term outcomes, the inferiority of TIF to fundoplication, and its modest efficacy in only highly selected patients. TIF may have a role for patients with mild GERD who are not willing to take PPIs or undergo antireflux surgery.Strong recommendation, moderate quality of evidence, level of agreement 92.8 %.ESGE recommends against the use of the Medigus ultrasonic surgical endostapler (MUSE) in clinical practice because of insufficient data showing its effectiveness and safety in patients with GERD. MUSE should be used in clinical trials only.Strong recommendation, low quality evidence, level of agreement 100 %.ESGE recommends against the use of antireflux mucosectomy (ARMS) in routine clinical practice in the treatment of GERD because of the lack of data and its potential complications.Strong recommendation, low quality evidence, level of agreement 100 %.ESGE recommends endoscopic cecostomy only after conservative management with medical therapies or retrograde lavage has failed.Strong recommendation, low quality evidence, level of agreement 93.3 %.ESGE recommends fixing the cecum to the abdominal wall at three points (using T-anchors, a double-needle suturing device, or laparoscopic fixation) to prevent leaks and infectious adverse events, whatever percutaneous endoscopic cecostomy method is used.Strong recommendation, very low quality evidence, level of agreement 86.7 %.ESGE recommends considering endoscopic decompression of the colon in patients with Ogilvie's syndrome that is not improving with conservative treatment.Strong recommendation, low quality evidence, level of agreement 93.8 %.ESGE recommends prompt endoscopic decompression if the cecal diameter is > 12 cm and if the Ogilvie's syndrome exists for a duration of longer than 4 - 6 days.Strong recommendation, low quality evidence, level of agreement 87.5 %.

Translation of the nine item avoidant/restrictive food intake disorder screen (NIAS) questionnaire in French (NIAS-Fr).

BACKGROUND: The Nine Item Avoidant/Restrictive Food Intake Disorder (ARFID) Screen (NIAS) questionnaire is originally available in English. Given the significant overlap of ARFID-like symptoms in gastrointestinal (GI) diseases, ARFID screening becomes crucial in these patient populations. Consequently, the translation of the NIAS questionnaire into French is necessary for its utilization in French-speaking countries. METHODS: Clinical experts in neuro-gastroenterology and dietetics from four medical centres in two French-speaking countries (France and Belgium) took part in a well-structured questionnaire translation procedure. This process involved six steps before final approval: translation from English to French, backward translation, comparison between the original and retranslated versions, testing the translated version on patients, making corrections based on patient feedback, and testing the corrected version on an additional sample of patients. KEY RESULTS: The NIAS questionnaire in French (NIAS-Fr) was tested on 18 outpatients across the involved centres. For the majority of native French-speaking patients, the translated questionnaire was well understood and clear. After incorporating two relevant modifications suggested by the patients, the translated questionnaire was approved through testing on an additional sample of patients. CONCLUSIONS AND INFERENCES: The involvement of two French-speaking countries was crucial for the harmonization and cultural adaptation of the questionnaire. As a result, the NIAS-Fr is now available for use in 54 French-speaking countries, serving approximately 321 million French speakers across five continents for screening ARFID, for both clinical and research purposes.

Three-year results of a multicenter prospective study of transoral incisionless fundoplication.

BACKGROUND: To date, there are no long-term data on the use of transoral incisionless fundoplication (TIF) for the treatment of chronic gastroesophageal reflux disease (GERD). We sought to prospectively evaluate the long-term safety and durability of TIF in a multi-center setting. METHODS: A longitudinal per protocol (PP) and a modified intention-to-treat (mITT) analysis at 1 and 3 years consisted of symptom evaluation using the GERD health-related quality of life (GERD-HRQL) questionnaire, medication use, upper gastrointestinal endoscopy, and pH-metry. RESULTS: Of 79 patients previously reported at 1 year, 12 were lost to follow-up, and 1 died from an unrelated cause. The remaining 66 patients were followed up and analyzed (mITT). Of 66 patients, 12 underwent revisional procedures, leaving 54 patients for PP analysis at a median of 3.1 years (range = 2.9-3.6). No adverse events related to TIF were reported at 2- or 3-year follow-up. On PP analysis, median GERD-HRQL score off proton pump inhibitors (PPIs) improved significantly to 4 (range 0-32) from both off (25 [13-38], P < .0001) and on (9 [0-22], P < .0001) PPIs. Discontinuation of daily PPIs was sustained in 61% (mITT) and 74% (PP) of patients. Of 11 patients with pH data at 3 years (PP), 9 (82%) remained normal. Based on mITT analysis, 9/23 (39%) remained normal at 3 years. CONCLUSIONS: The clinical outcomes at 3 years following TIF, patient satisfaction, healing of erosive esophagitis, and cessation of PPI medication support long-term safety and durability of the TIF procedure for those with initial treatment success. Although complete normalization of pH studies occurred in a minority of patients, successful cases showed long-term durability.

Primary Helicobacter pylori resistance to antimicrobials in the Brussels area in 2021.

This manuscript summarizes current primary resistance of Helicobacter pylori to antibiotics in Brussels in 2021. Resistance rates were estimated at 18% for clarithromycin, 24% for levofloxacin, 52% for metronidazole, and 0% for amoxicillin and tetracycline. When compared to 2016, resistance rates remain stable, except an increase of 30% for metronidazole.

Pilot study of an endoluminal-suturing device as a treatment for patients with gastroesophageal reflux disease.

Background and study aims Endoscopic therapy is a promising option for patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess safety and feasibility of the Endomina suturing platform as a treatment for GERD. Patients and methods This was a two-center study of patients with chronic GERD symptoms that responded at least partially to proton pump inhibitors (PPIs). Primary endpoints were to assess the safety of the procedure and persistence of the sutures. Secondary endpoints were to assess esophageal pH-impedance and manometry parameters changes at 6 months, as well as GERD symptoms and PPI use up to 12 months of follow-up. Results Fourteen patients were treated (13 males, mean of 43±12 years), with a mean number of three plications per patient. Thirteen, 10, and nine patients were analyzed at 3, 6, and 12 months of follow-up, respectively. One device-related adverse event occurred (loss of needle tip requiring endoscopic retrieval 1 week later). A mean of two plications persisted at 3 and 12 months. A decrease in median acid exposure time and reflux episodes was observed after the procedure. Mean Reflux Symptom Index and GERD-Health-Related Quality of Life scores decreased during follow-up visits and 90% of the patients discontinued PPI use at 1 year. Conclusions Endoscopic full-thickness suturing of the esophagogastric junction with the Endomina suturing platform is feasible, allowing persistence of two-thirds of the plications, with promising results for decreasing reflux and improving GERD symptoms.

Guidewire-assisted placement of water-perfused esophageal high-resolution manometry probe when gastric insertion fails: A single-center experience.

BACKGROUND: Blind positioning of a high-resolution manometry (HRM) probe across the esophagogastric junction (EGJ) is not always possible. We report our experience using guidewire-assisted water-perfused HRM probe insertion when the EGJ could not be traversed. METHODS: Retrospective study analyzing the failure rate of EGJ insertion during HRM, and reporting a series of guidewire-assisted procedures. KEY RESULTS: Among 2727 HRM procedures, the failure rate for traversing the EGJ was 2.7% (73 patients). The technique of guidewire-assisted placement of the HRM probe was used in 25 patients; it was well-tolerated and successful in all patients. No motility disorder was found in 6 patients. In four patients with previously diagnosed achalasia, achalasia subtype changed to type III in one patient. While a suspected motility disorder at barium esophagram and/or initial imperfect HRM tracing was confirmed in 10 patients, a new motility disorder was diagnosed in five patients using guidewire-assisted placement of the HRM probe. CONCLUSIONS AND INFERENCES: In cases of inability to traverse the EGJ, insertion of a water-perfused HRM probe using an endoscopically-placed nasogastric guidewire allows successful EGJ and esophageal peristalsis assessment. Although motility disorders are often suspected using alternative diagnostic modalities, guidewire-assisted placement of HRM may be helpful for revealing them in patients where alternative diagnostic modalities are either unavailable or inconclusive.

Pneumatic dilation for the treatment of persistent post-laparoscopic fundoplication dysphagia: long-term efficacy and safety.

BACKGROUND: Post-laparoscopic fundoplication (LF) dysphagia occurs in 5%-17% of patients and optimal management remains a topic of expert discussion. We assessed the efficacy and safety of pneumatic dilation (PD) in patients with persistent post-lLF dysphagia. METHODS: Medical files of patients treated with PD for persistent post-fundoplication-associated dysphagia were reviewed. The primary outcome was long-term clinical success. Secondary endpoints were initial clinical success, dysphagia recurrence rate, and PD-related complication incidence. RESULTS: Overall, 46 patients (74% women, 57.9±11.9 years) underwent 74 PD (mean: 1.6±0.8). A 30 mm, 35 mm, and 40 mm balloon was used in 45.9%, 43.2%, and 10.8%, respectively, of dilations. Among 45 patients with available follow-up, the overall long-term success rate of PD was 31/45 (68.9% [55.4-82.4]). Initial clinical success was 36/45 (80% [68.3-91.7]). Dysphagia recurred in 9 patients (25%; 95%CI 10.9-39.1) and 4 of these were effectively treated with a new dilation. Among 14 non-responders to PD, 11 underwent surgery. Four complications (2 perforations, 1 muscularis dilaceration, and 1 peri-procedural bleeding) occurred in 4 patients (incidence: 5.4% [95%CI; 0.3-10.6]) and were treated with partially covered self-expandable esophageal stents andhemostatic clips. CONCLUSIONS: Pneumatic balloon dilation for post-fundoplication-associated symptoms is associated with a satisfactory long-term success rate and acceptable safety profile.

Feasibility of a low FODMAPs diet without initial dietician intervention in the management of patients with irritable bowel syndrome: a prospective study.

BACKGROUND AND AIMS: Efficiency of a low FODMAPs diet (LFD) to relieve symptoms in patients with irritable bowel syndrome (IBS) has been proved in several studies. Our study aimed to evaluate the management of IBS-patients when explanations about LFD are given by the physician without dietician intervention. PATIENTS AND METHODS: Patients with IBS were evaluated prospectively after explanations about the LFD were given with the help of a leaflet. A first questionnaire evaluating trigger foods and diet acceptability was submitted to the patient after the consultation. Six weeks later, a second questionnaire evaluated patient's understanding and adherence to the diet, the evolution of symptoms, and the need for a specific dietetic support. RESULTS: Thirty-five patients were included (69% female; mean age 45±15). Seventy-four percent of the patients thought that their symptoms were related to food ingestion, and 97% were ready to go on a diet to improve their symptoms. During the second visit, 91% of the patients reported understanding correctly the explanations, 52% followed LFD regularly, 28% sometimes and 20% did not follow LFD at all or barely. Multiple non-adherence factors were reported. All symptoms, except constipation, decreased significantly six weeks after starting LFD. Finally, 77% of the patients reported satisfaction with care and 69% were willing to be supported by a dietician. CONCLUSIONS: Most IBS patients understood explanations given by GI physicians, but low compliance to the diet and a wish for dietician support was highlighted, suggesting that a dietician intervention should be scheduled when LFD is implemented.

Endoscopic Dilation of Post-Sleeve Gastrectomy Stenosis: Long-Term Efficacy and Safety Results.

INTRODUCTION: Post-sleeve gastrectomy (SG) stenoses occur in about 5% of cases. Hydrostatic dilation (HD) and pneumatic dilation (PD) have been proposed as treatments, but efficacy data remain scarce. Objective is to describe long-term efficacy and safety of HD and PD. METHODS: This retrospective study in a referral endoscopy center included patients with symptomatic post-SG stenosis treated with endoscopic balloon dilation (EBD). Stenosis was defined as "organic" if luminal narrowing was evident, "functional" for a deformation, or "combined." Endoscopic treatment consisted of ≥ 1 HD (15-20 mm) and/or ≥ 1 PD (30-35 mm). Initial success was defined as improvement of stenosis-related symptoms at 1 month and long-term success as persistence of improvement at last follow-up. RESULTS: Forty-four patients (73% women; mean age 45.5 ± 11 years; mean follow-up 26 ± 23 months) underwent EBD between 2013 and 2019. HD and PD were used in 15 (34%) and 29 (66%) patients, respectively, (mean dilation number: 1.8 ± 1.1). Post-SG stenoses were considered organic in 10 (23%), functional in 21 (48%), and combined in 13 (29%) patients. Initial success was achieved in 42 (96%) patients, while 35 (80%) patients had no symptom recurrence at last follow-up. Perforation occurred in one patient. HD was more frequently used in organic stenoses (8/10), while PD in functional and combined stenoses (18/21 and 9/13, respectively; p < 0.001). Rates of success did not differ by type of stenosis. CONCLUSION: Endoscopic dilation is an effective treatment for post-SG stenoses, providing long-term symptom relief. PD should be preferred in cases of functional stenoses, and HD used for organic stenoses.

Management of esophageal motility disorders in children : a review.

Diagnostic criteria for esophageal motor disorders have recently been updated with the advent of high-resolution manometry that gives a precise mapping of peristaltic abnormalities and an indirect view of bolus transit problems. Achalasia, the best-defined motor disorder, is now divided in subsets of manometric phenotypes that predict outcome of treatment and guide our therapeutic approach. Pharmacological therapy using smooth muscle relaxants for spastic esophageal disorders remains poorly effective and used only as a bridge to more effective therapies : endoscopic balloon dilation and surgical myotomy are both effective therapies in achalasia, myotomy being considered as the preferred approach in children because it is aimed to be definitive, while dilations usually have to be repeated. Recently, peroral endoscopic myotomy was introduced as an alternative to surgical myotomy for achalasia, and was rapidly adopted in tertiary referral centers. Showing excellent short-term results, this technique might be also proposed for other esophageal spastic disorders. Gastroesophageal reflux disease and eosinophilic esophagitis, two prevalent diseases in children that may be associated with hypotensive and hypertensive peristaltic abnormalities, have to be searched because specific effective therapies exist for these diseases that may cure the motility disorders.

Peroral endoscopic myotomy is effective and safe in non-achalasia esophageal motility disorders: an international multicenter study.

BACKGROUND AND STUDY AIMS: The efficacy of per oral endoscopic myotomy (POEM) in non-achalasia esophageal motility disorders such as esophagogastric junction outflow obstruction (EGJOO), diffuse esophageal spasm (DES), and jackhammer esophagus (JE) has not been well demonstrated. The aim of this international multicenter study was to assess clinical outcomes of POEM in patients with non-achalasia disorders, namely DES, JE, and EGJOO, in a large cohort of patients. PATIENTS AND METHODS: This was a retrospective study at 11 centers. Consecutive patients who underwent POEM for EGJOO, DES, or JE between 1/2014 and 9/2016 were included. Rates of technical success (completion of myotomy), clinical response (symptom improvement/Eckardt score ≤ 3), and adverse events (AEs, severity per ASGE lexicon) were ascertained . RESULTS: Fifty patients (56 % female; mean age 61.7 years) underwent POEM for EGJOO (n = 15), DES (n = 17), and JE (n = 18). The majority of patients (68 %) were treatment-naïve. Technical success was achieved in all patients with a mean procedural time of 88.4 ±â€Š44.7 min. Mean total myotomy length was 15.1 ±â€Š4.7 cm. Chest pain improved in 88.9 % of EGJOO and 87.0 % of DES/JE ( P  = 0.88). Clinical success was achieved in 93.3 % of EGJOO and in 84.9 % of DES/JE ( P  = 0.41) with a median follow-up of 195 and 272 days, respectively. Mean Eckardt score decreased from 6.2 to 1.0 in EGJOO ( P  < 0.001) and from 6.9 to 1.9 in DES/JE ( P  < 0.001). A total of 9 (18 %) AEs occurred and were rated as mild in 55.6 % and moderate in 44.4 %. CONCLUSION: POEM is effective and safe in management of non-achalasia esophageal motility disorders, which include DES, JE, and EGJOO.

Enteryx.

Enteryx (ethylene vinyl alcohol copolymer) was developed as a bulking agent to be injected endoscopically at the lower oesophageal sphincter (LOS) to increase the competency of the gastro-oesophageal barrier in patients suffering from gastro-oesophageal reflux disease (GORD). Preliminary clinical studies have shown that Enteryx implantation is a fast, minimally invasive and safe procedure. In prospective multicentre studies, significant improvement in reflux symptoms, reduction in the use of proton pump inhibitors (PPIs), and objective improvement in acid oesophageal exposure time were observed after 6 months of follow-up. Improvement of GORD symptoms seems to be correlated with the persistence of the implant. Preliminary data suggest a lengthening and an increase in the LOS relaxation pressure as mechanisms of action of this injection technique. Longer follow-up and controlled sham studies are needed to confirm the efficacy of this technique before it can be proposed as a routine alternative to medical or surgical therapies for GORD.

Endoscopic implantation of enteryx for the treatment of gastroesophageal reflux disease: technique, pre-clinical and clinical experience.

The implantation of Enteryx polymer in the LES is a fast, minimally invasive procedure with anticipated low procedural risks and limited costs. Preliminary clinical data after 6 months of follow-up show good results in more than 80% of the patients, with objective improvement of acid reflux time. Enteryx is effective in the management of GERD, as evidenced by the ability of GERD patients with a history of use of PPIs and other GERD medications to eliminate or significantly reduce use of these medications. Mechanisms of action of Enteryx implantation suggest a change in distensibility of the LES, allowing a greater competency of the cardia. LES pressure and length might be increased after polymer implantation, and further studies are needed to study the effect of Enteryx on transient relaxations of the LES, which is the prevalent mechanism of reflux in patients with mild GERD. Challenges with this procedure include refining technique to deliver adequate volume in each patient and determining if the ring-shaped implant is needed. In addition to acid reflux, another indication for use of this treatment might be biliary reflux in gastrectomized patients; preliminary data suggest that Enteryx may reduce symptoms and improve bile reflux (J. Devière, unpublished observations, 2002). Further studies are needed to definitively establish the safety of the procedure. This is a major point because gastroenterologists are not dealing with ill patients but primarily with individuals who have a good quality of life while taking PPIs. The other area to investigate is the efficacy of the treatment through a sham-controlled study. Finally, this endoscopic technique will have to be evaluated in terms of cost-effectiveness against medical and surgical therapies.