Replogle Modified Endoscopic Vacuum-Assisted Closure (EVAC) Therapy: A New Strategy to Treat Anastomotic Leakage and Esophageal Perforation.

BACKGROUND: Anastomotic leakage (AL) and esophageal perforation are life-threatening complications following surgery or endoscopic dilations. "Replogle modified EVAC therapy" consists of placing a Replogle tube directly into the lumen or within an abscess cavity and remove by suction all intra-cavity fluids and secretion with a continuous low-pressure suction, promoting granulation tissue proliferation, thereby gradually decreasing the cavity size. The aim of our study was to evaluate the technical feasibility, safety, and efficacy of this technique in pediatric patients. METHODS: A retrospective review charts of consecutive pediatric patients that were treated with "Replogle modified EVAC therapy" at our pediatric referral center between 2013 and 2022 was conducted. The clinical, endoscopic, radiological, and surgical information and data of patients were collected and revised as well as their follow-up and outcomes. RESULTS: Ten patients (6/10 male; mean age: 7.8 y.o., range: 1.1-18 y.o.) were treated using the "Replogle modified EVAC therapy". Four out of ten patients developed esophageal perforations after endoscopic procedures. Six out of the ten enrolled patients had AL complications after surgical operations. All patients were successfully treated. There were no technical failures or complications with device placement. Mean treatment duration was 16 days (range 7-41 days). No additional treatment was needed for complete leak resolution. CONCLUSIONS: "Replogle modified EVAC therapy" represents a promising and mini-invasive method to treat esophageal perforations and post-surgical leak in the paediatric age group. In our experience, the use of this technique was safe, effective, and particularly well suited also in complex paediatric patients. LEVEL OF EVIDENCE: IV.

Decellularized esophageal tubular scaffold microperforated by quantum molecular resonance technology and seeded with mesenchymal stromal cells for tissue engineering esophageal regeneration.

Current surgical options for patients requiring esophageal replacement suffer from several limitations and do not assure a satisfactory quality of life. Tissue engineering techniques for the creation of customized "self-developing" esophageal substitutes, which are obtained by seeding autologous cells on artificial or natural scaffolds, allow simplifying surgical procedures and achieving good clinical outcomes. In this context, an appealing approach is based on the exploitation of decellularized tissues as biological matrices to be colonized by the appropriate cell types to regenerate the desired organs. With specific regard to the esophagus, the presence of a thick connective texture in the decellularized scaffold hampers an adequate penetration and spatial distribution of cells. In the present work, the Quantum Molecular Resonance® (QMR) technology was used to create a regular microchannel structure inside the connective tissue of full-thickness decellularized tubular porcine esophagi to facilitate a diffuse and uniform spreading of seeded mesenchymal stromal cells within the scaffold. Esophageal samples were thoroughly characterized before and after decellularization and microperforation in terms of residual DNA content, matrix composition, structure and biomechanical features. The scaffold was seeded with mesenchymal stromal cells under dynamic conditions, to assess the ability to be repopulated before its implantation in a large animal model. At the end of the procedure, they resemble the original esophagus, preserving the characteristic multilayer composition and maintaining biomechanical properties adequate for surgery. After the sacrifice we had histological and immunohistochemical evidence of the full-thickness regeneration of the esophageal wall, resembling the native organ. These results suggest the QMR microperforated decellularized esophageal scaffold as a promising device for esophagus regeneration in patients needing esophageal substitution.

Endoscopic ultrasound-guided gastrojejunostomy with lumen-apposing metal stent in a boy with neurological impairment requiring jejunal feeding.

Video 1EUS-guided, LAMS-assisted gastrojejunostomy for re-routing a PEGJ tube in neurologically impaired children.

Direct visualization of biliary stump polyp in a boy with recurrent pancreatitis after surgery for pancreatobiliary maljunction associated with choledocal cyst.

Video 1Direct cholangioscopy for pancreatobiliary maljunction.

Accuracy of visual on-site evaluation (Vose) In predicting the adequacy of Eus-guided fine needle biopsy: A single center prospective study.

OBJECTIVE: Endoscopic ultrasound is the standard procedure for the diagnosis of pancreatic lesions and new needles have been developed to improve tissue acquisition (FNB). Rapid onset evaluation (ROSE) decreases the number of needle passes but is not always available. We introduced an easy and rapid method of direct classification of EUS-FNB sample namely Visual on-site evaluation (VOSE). AIMS: To assess the accuracy of VOSE in predicting the histological adequacy of specimens. To evaluate the diagnostic power of FNB and the rate of core tissue obtained. METHODS: Prospective single center study on patients with pancreatic lesions that underwent EUS-FNB. VOSE parameters were presence of blood, macroscopic visible core (MVC), number, color and length of specimen. The association between VOSE tool and histological adequacy was assessed. Fisher's exact test and Student's t-test used to compare categorical and continuous variables. Logistic regression analysis was used to assess association between variables. RESULTS: 99 patients (58.6% male; mean age 68.4 ± 10) enrolled, including 102 lesions. Total number of passes was 358 with median number of 4 (range, 2-4). The 92.7% of samples were adequate and it was higher with the 22-G needle than with 25G (96.5% vs 89.2% p 0.01). VOSE "red-mixed specimen" was associated with a higher probability of histological adequacy (OR 2.39 95% CI 1.03-5.42 p = 0.04). CONCLUSIONS: The VOSE tool "red-mixed specimen" can be used to predict the histological adequacy and guide the number of needle passes. Overall, FNB provides a high rate of adequate and diagnostic specimen and high rate of core tissue especially with the 22G needle.

Duodenal Duplication Cysts in Children: Clinical Features and Current Treatment Choices.

BACKGROUND: Duodenal duplication cysts are rare gastrointestinal tract malformations. Most patients experience symptom onset in the first decade of life. This review aims to examine clinical presentation, management strategies and outcomes of duodenal duplication cysts in childhood. METHODS: A Pubmed/Medline (http://www.ncbi.nlm.nih.gov/pubmed/) search in October 2019 for articles published since 1999 using the keywords "duodenal duplication cyst," "child" and "newborn" was carried out. Clinical symptoms, complications, diagnostic examinations, treatment options and outcomes were analyzed and tabulated. RESULTS: There were 41 citations in the literature providing adequate descriptions of 45 cases of duodenal duplication cysts. The age of presentation ranged from newborn to 18 years. The median interval between initial presentation and definitive diagnosis and treatment was 17 months (range: 2 months to 12 years). Overall, 67% of cases presented with abdominal pain, and 43% were complicated with pancreatitis. Different surgical and endoscopic therapeutic strategies were reported. CONCLUSIONS: Duodenal duplication cysts may be associated with life-threatening complications and/or recurrent symptoms, impairing quality of life. Early recognition of patients who demonstrate suggestive signs and symptoms is important to ensure success of treatment. This review may be useful to highlight the main diagnostic aspects and limit the risk of a delayed diagnosis.

Successful muscle regeneration by a homologous microperforated scaffold seeded with autologous mesenchymal stromal cells in a porcine esophageal substitution model.

BACKGROUND: Since the esophagus has no redundancy, congenital and acquired esophageal diseases often require esophageal substitution, with complicated surgery and intestinal or gastric transposition. Peri-and-post-operative complications are frequent, with major problems related to the food transit and reflux. During the last years tissue engineering products became an interesting therapeutic alternative for esophageal replacement, since they could mimic the organ structure and potentially help to restore the native functions and physiology. The use of acellular matrices pre-seeded with cells showed promising results for esophageal replacement approaches, but cell homing and adhesion to the scaffold remain an important issue and were investigated. METHODS: A porcine esophageal substitute constituted of a decellularized scaffold seeded with autologous bone marrow-derived mesenchymal stromal cells (BM-MSCs) was developed. In order to improve cell seeding and distribution throughout the scaffolds, they were micro-perforated by Quantum Molecular Resonance (QMR) technology (Telea Electronic Engineering). RESULTS: The treatment created a microporous network and cells were able to colonize both outer and inner layers of the scaffolds. Non seeded (NSS) and BM-MSCs seeded scaffolds (SS) were implanted on the thoracic esophagus of 4 and 8 pigs respectively, substituting only the muscle layer in a mucosal sparing technique. After 3 months from surgery, we observed an esophageal substenosis in 2/4 NSS pigs and in 6/8 SS pigs and a non-practicable stricture in 1/4 NSS pigs and 2/8 SS pigs. All the animals exhibited a normal weight increase, except one case in the SS group. Actin and desmin staining of the post-implant scaffolds evidenced the regeneration of a muscular layer from one anastomosis to another in the SS group but not in the NSS one. CONCLUSIONS: A muscle esophageal substitute starting from a porcine scaffold was developed and it was fully repopulated by BM-MSCs after seeding. The substitute was able to recapitulate in shape and function the original esophageal muscle layer.

Retraction notice to "Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study": [YMGE 85 (2017) 927-933].

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted due to overlapping/duplicate material. Data from some patients from this study have previously been published in other journals without cross-referencing. Twenty patients overlap with a paper by Kumbhari et al.1 Thirty-five patients overlap with the study by Ngamruengphong et al.2.

Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma.

BACKGROUND AND AIMS: EUS has become an interventional technique in which a needle may be used as a vehicle to deliver therapeutic agents. Laser ablation (LA) has been used to treat many primary and secondary neoplasms. This study aimed to assess the feasibility of EUS-guided LA for unresectable (UR) pancreatic cancer. METHODS: Patients with stage IIb-III pancreatic cancer underwent EUS-guided LA. All patients were unresponsive to previous chemoradiotherapy. LA was performed by using a 300-µm flexible fiber preloaded onto a 22-gauge fine needle. A 1064-nm wavelength neodymium-yttrium aluminum garnet (Nd:YAG) laser light with different power settings of 2 W for 800 J, 1000 J, and 1200 J; 3 W for 800 J, 1000 J, and 1200 J; and 4 W for 800 J, 1000 J, and 1200 J was used. Each patient was treated with a single application of 1 of these settings. The application time of the power settings ranged from 200 to 600 seconds. RESULTS: Nine patients (median age, 74.7; range 55-85) underwent Nd:Yag LA. The mean size of the focal lesion was 35.4 mm (range, 21-45). The ablation area, demonstrated by 24-hour CT, ranged from .4 cm3 (for the lower power setting of 2 W/800 J) to a maximum of 6.4 cm3 (for 4 W/1000 J). The procedure was completed in all 9 patients without adverse events. CONCLUSION: In our human experience, EUS-guided LA was feasible and well tolerated in patients with UR pancreatic cancer.

An international multicenter study evaluating the clinical efficacy and safety of per-oral endoscopic myotomy in octogenarians.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) for achalasia is particularly appealing in the elderly because it is minimally invasive. However, data in patients aged ≥80 years are scarce. The aim of this study was to assess the clinical outcome of POEM in octogenarians. METHODS: This was a multicenter retrospective study at 8 centers. Consecutive octogenarians with achalasia who underwent POEM between 2010 and 2016 were included. Rates of technical success (completion of myotomy), clinical response (Eckardt score ≤3), and adverse events (severity graded as per American Society for Gastrointestinal Endoscopy lexicon) were assessed. RESULTS: A total of 76 patients (47.4% female, mean age 84 years) underwent POEM for treatment of achalasia: type I, 17.1%; type II, 35.5%; type III, 17.1%; and unspecified, 30.3%. Overall, 41.1% were treatment naïve, whereas others had previous botulinum toxin injection and/or pneumatic dilation. The mean (± standard deviation [SD]) age-adjusted Charlson comorbidity index score was 6.2 ± 2.4, with the majority of patients having American Society of Anesthesiologists Physical Status Classification System (ASA) scores of II/III. Technical success was 93.4%, with a median follow-up of 256 days. Fourteen adverse events occurred in 11 patients (14.5%). There were 3 inadvertent mucosotomies, 6 cases of symptomatic capnoperitoneum and/or capnomediastinum, 2 esophageal leaks, 1 cardiac arrhythmia, and 2 other). The severities of these adverse events were mild (78.6%), moderate (14.3%), and severe (7.1%). Clinical success was achieved in 90.8% of patients, with a mean (± SD) Eckardt score reduction from 7.0 ± 2.3 to 0.8 ± 0.1 (P < .001), a median follow-up of 256 days, and interquartile range of 66 to 547. CONCLUSION: Although the rate of technical success may be somewhat lower and the rate of adverse events slightly higher than previously reported, our data suggest that POEM in octogenarians is safe and effective, supporting its role as a primary modality for achalasia in this patient population.

Peroral endoscopic myotomy as salvation technique post-Heller: International experience.

BACKGROUND: Treatment for achalasia has traditionally been Heller myotomy (HM). Despite its excellent efficacy rate, a number of patients remain symptomatic post-procedure. Limited data exist as to the best management for recurrence of symptoms post-HM. We present an international, multicenter experience evaluating the efficacy and safety of post-HM peroral endoscopic myotomy (POEM). METHODS: Patients who underwent POEM post-HM from 13 centers from January 2012 to January 2017 were included as part of a prospective registry. Technical success was defined as successful completion of the myotomy. Clinical success was defined as an Eckardt score of ≤3 on 12-month follow up. Adverse events (AE) including anesthesia-related, operative, and postoperative complications were recorded. RESULTS: Fifty-one patients were included in the study (mean age 54.2, 47% male). Technical success was achieved in 100% of patients. Clinical success on long-term follow up was achieved in 48 patients (94%), with a mean change in Eckardt score of 6.25. Seven patients (13%) had AE: six experienced periprocedural mucosal defect treated endoscopically and two patients developed mediastinitis treated conservatively. CONCLUSION: For patients with persistent symptoms after HM, POEM is a safe salvation technique with good short-term efficacy. As a result of the challenge associated with repeat HM, POEM might become the preferred technique in this patient population. Further studies with longer follow up are needed.

Anastomotic Strictures after Esophageal Atresia Repair: Incidence, Investigations, and Management, Including Treatment of Refractory and Recurrent Strictures.

Improved surgical techniques, as well as preoperative and postoperative care, have dramatically changed survival of children with esophageal atresia (EA) over the last decades. Nowadays, we are increasingly seeing EA patients experiencing significant short- and long-term gastrointestinal morbidities. Anastomotic stricture (AS) is the most common complication following operative repair. An esophageal stricture is defined as an intrinsic luminal narrowing in a clinically symptomatic patient, but no symptoms are sensitive or specific enough to diagnose an AS. This review aims to provide a comprehensive view of AS in EA children. Given the lack of evidence-based data, we critically analyzed significant studies on children and adults, including comments on benign strictures with other etiologies. Despite there is no consensus about the goal of the luminal diameter based on the patient's age, esophageal contrast study, and/or endoscopy are recommended to assess the degree of the narrowing. A high variability in incidence of ASs is reported in literature, depending on different definitions of AS and on a great number of pre-, intra-, and postoperative risk factor influencing the anastomosis outcome. The presence of a long gap between the two esophageal ends, with consequent anastomotic tension, is determinant for stricture formation and its response to treatment. The cornerstone of treatment is endoscopic dilation, whose primary aims are to achieve symptom relief, allow age-appropriate capacity for oral feeding, and reduce the risk of pulmonary aspiration. No clear advantage of either balloon or bougie dilator has been demonstrated; therefore, the choice is based on operator experience and comfort with the equipment. Retrospective evidences suggest that selective dilatations (performed only in symptomatic patients) results in significantly less number of dilatation sessions than routine dilations (performed to prevent symptoms) with equal long-term outcomes. The response to dilation treatment is variable, and some patients may experience recurrent and refractory ASs. Adjunctive treatments have been used, including local injection of steroids, topical application of mitomycin C, and esophageal stenting, but long-term studies are needed to prove their efficacy and safety. Stricture resection or esophageal replacement with an interposition graft remains options for AS refractory to conservative treatments.

Comprehensive Analysis of Adverse Events Associated With Per Oral Endoscopic Myotomy in 1826 Patients: An International Multicenter Study.

OBJECTIVES: The safety of peroral endoscopic myotomy (POEM) is still debated since comprehensive analysis of adverse events (AEs) associated with the procedure in large multicenter cohort studies has not been performed. To study (1) the prevalence of AEs and (2) factors associated with occurrence of AEs in patients undergoing POEM. METHODS: Patients who underwent POEM at 12 tertiary-care centers between 2009 and 2015 were included in this case-control study. Cases were defined by the occurrence of any AE related to the POEM procedure. Control patients were selected for each AE case by matching for age, gender, and disease classification (achalasia type I and II vs. type III/spastic esophageal disorders). RESULTS: A total of 1,826 patients underwent POEM. Overall, 156 AEs occurred in 137 patients (7.5%). A total of 51 (2.8%) inadvertent mucosotomies occurred. Mild, moderate, and severe AEs had a frequency of 116 (6.4%), 31 (1.7%), and 9 (0.5%), respectively. Multivariate analysis demonstrated that sigmoid-type esophagus (odds ratio (OR) 2.28, P=0.05), endoscopist experience <20 cases (OR 1.98, P=0.04), use of a triangular tip knife (OR 3.22, P=0.05), and use of an electrosurgical current different than spray coagulation (OR 3.09, P=0.02) were significantly associated with the occurrence of AEs. CONCLUSIONS: This large study comprehensively assessed the safety of POEM and highly suggests POEM as a relatively safe procedure when performed by experts at tertiary centers with an overall 7.5% prevalence of AEs. Severe AEs are rare. Sigmoid-type esophagus, endoscopist experience, type of knife, and current used can be considered as predictive factors of AE occurrence.

Efficacy and Safety of Peroral Endoscopic Myotomy for Treatment of Achalasia After Failed Heller Myotomy.

BACKGROUND & AIMS: In patients with persistent symptoms after Heller myotomy (HM), treatment options include repeat HM, pneumatic dilation, or peroral endoscopic myotomy (POEM). We evaluated the efficacy and safety of POEM in patients with achalasia with prior HM vs without prior HM. METHODS: We conducted a retrospective cohort study of 180 patients with achalasia who underwent POEM at 13 tertiary centers worldwide, from December 2009 through September 2015. Patients were divided into 2 groups: those with prior HM (HM group, exposure; n = 90) and those without prior HM (non-HM group; n = 90). Clinical response was defined by a decrease in Eckardt scores to 3 or less. Adverse events were graded according to criteria set by the American Society for Gastrointestinal Endoscopy. Technical success, clinical success, and rates of adverse events were compared between groups. Patients were followed up for a median of 8.5 months. RESULTS: POEM was technically successful in 98% of patients in the HM group and in 100% of patients in the non-HM group (P = .49). A significantly lower proportion of patients in the HM group had a clinical response to POEM (81%) than in the non-HM group (94%; P = .01). There were no significant differences in rates of adverse events between the groups (8% in the HM group vs 13% in the non-HM group; P = .23). Symptomatic reflux and reflux esophagitis after POEM were comparable between groups. CONCLUSIONS: POEM is safe and effective for patients with achalasia who were not treated successfully by prior HM. Although the rate of clinical success in patients with prior HM is lower than in those without prior HM, the safety profile of POEM is comparable between groups.

The importance of a second opinion in the diagnosis of Barrett's esophagus: a "real life" study.

BACKGROUND: Barrett's esophagus is a precancerous lesion, and its identification with the early detection of dysplasia is of paramount importance to prevent adenocarcinoma onset. However, there is still debate on the correct pathological identification of Barrett's esophagus (and of associated dysplasia), and most studies have been conducted in an experimental setting. AIMS: To assess previous uncertain diagnoses of Barrett's (with and without dysplasia) via a second opinion of an expert pathologist in a real life setting. PATIENTS AND METHODS: Histological sections of 32 suspected Barrett's patients from ten general Pathology units were centralized into one single unit in which an expert pathologist reviewed the slides blindly. RESULTS: Overall, in 78% of cases there was diagnostic discordance; in particular, in 64% of cases the presence of low grade dysplasia was not confirmed. Of interest, 28% of cases with the original diagnosis were reclassified as non-Barrett's. CONCLUSIONS: The pathological diagnosis of Barrett's esophagus, especially with regard to the presence of dysplasia, is still misinterpreted, particularly in the setting of general Pathology units. Thus, a second opinion from an experienced pathologist may help in the interpretation of the results and in starting appropriate follow-up programs.

Long-term outcomes of per-oral endoscopic myotomy in patients with achalasia with a minimum follow-up of 2 years: an international multicenter study.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) has shown promising safety and efficacy in short-term studies. However, long-term follow-up data are very limited. The aims of this study were to assess (1) clinical outcome of patients with a minimum post-POEM follow-up of 2 years and (2) factors associated with long-term clinical failure after POEM. METHODS: A retrospective chart review was performed that included all consecutive patients with achalasia who underwent POEM with a minimum follow-up of 2 years at 10 tertiary-care centers. Clinical response was defined by a decrease in Eckardt score to 3 or lower. RESULTS: A total of 205 patients (45.8% men; mean age, 49 years) were followed for a median of 31 months (interquartile range, 26-38 months). Of these, 81 patients (39.5%) had received previous treatment for achalasia before POEM. Clinical success was achieved in 98% (185/189), 98% (142/144), and 91% (187/205) of patients with follow-up within 6 months, at 12 months, and ≥24 months, respectively. Of 185 patients with clinical response at 6 months, 11 (6%) experienced recurrent symptoms at 2 years. History of previous pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23). Procedure-related adverse events occurred in 8.2% of patients and only 1 patient required surgical intervention. Abnormal esophageal acid exposure and reflux esophagitis were documented in 37.5% and 18% of patients, respectively. However, these rates are simply a reference number among a very selective group of patients. CONCLUSIONS: POEM is safe and provides high initial clinical success and excellent long-term outcomes. Among patients with confirmed clinical response within 6 months, 6% had recurrent symptoms by 2 years.

A multicenter international registry of redo per-oral endoscopic myotomy (POEM) after failed POEM.

BACKGROUND AND AIMS: Per-oral endoscopic myotomy (POEM) has become an accepted treatment for patients with achalasia. Despite its excellent efficacy rate of greater than 80%, a small percentage of patients remain symptomatic after the procedure. Limited data exist as to the best management for recurrence of symptoms after POEM. We present the first international, multicenter experience on the efficacy and safety of a repeat POEM in the management of achalasia. METHODS: Patients who underwent a redo POEM from 15 centers in 9 countries were included in a dedicated registry. Technical success was defined as successful completion of a second myotomy. Clinical success was defined as an Eckardt score of less than or equal to 3 after the second myotomy. Adverse events including anesthesia-related, operative, and postoperative adverse events were recorded. RESULTS: Forty-six patients were included in the study. The average age was 49.3 ± 16.78 years. Twenty (45%) patients were male. The mean pre-redo-POEM Eckardt score was 4.3 ± 2.48. Technical success was achieved in 46 (100%) patients. Clinical success was achieved in 41 patients (85%). The average post-POEM Eckardt score was 1.64 ± 1.67, with a significant difference of 2.58 (P < .00001). Eight patients (17%) had adverse events consisting of procedural bleeding, all managed endoscopically. There were no deaths. No POEMs were aborted or required surgical conversion or assistance. DISCUSSION: For patients with persistent symptoms after POEM, repeat POEM appears to be an efficacious and safe technique. Further randomized trials comparing redo POEM versus Heller should be considered. (Clinical trial registration number: NCT02162589.).