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Background and aimsEndoscopic treatment of recurrent/residual colonic lesions on scars is a challenging procedure. In this setting, endoscopic submucosal dissection (ESD) is considered the first choice, despite a significant rate of complications. Endoscopic full-thickness resection (eFTR) has been shown to be well-tolerated and effective for these lesions. The aim of this study is to conduct a comparison of outcomes for resection of such lesions between ESD and eFTR in an Italian and a Japanese referral center.MethodsFrom January 2018 to July 2020, we retrospectively enrolled patients with residual/recurrent colonic lesions, 20 treated by eFTR in Italy and 43 treated by ESD in Japan. The primary outcome was to compare the two techniques in terms of en-bloc and R0-resection rates, whereas complications, time of procedure, and outcomes at 3-month follow-up were evaluated as secondary outcomes.ResultsR0 resection rate was not significantly different between the two groups [18/20 (90%) and 41/43 (95%); P= 0.66]. En-bloc resection was 100% in both groups. No significant difference was found in the procedure time (54 min vs. 61 min; P= 0.9). There was a higher perforation rate in the ESD group [11/43 (26%) vs. 0/20 (0%); P= 0.01]. At the 3-month follow-up, two lesions relapsed in the eFTR cohort and none in the ESD cohort (P= 0.1).ConclusioneFTR is a safer, as effective and equally time-consuming technique compared with ESD for the treatment of residual/recurrent colonic lesions on scars and could become an alternative therapeutic option for such lesions.

Endoscopic Retrograde Cholangio-Pancreatography (ERCP) with biliary stenting is a minimally invasive medical procedure employed to address both malignant and benign obstructions within the biliary tract. Benign biliary strictures (BBSs), typically arising from surgical interventions such as liver transplants and cholecystectomy, as well as chronic inflammatory conditions, present a common clinical challenge. The current gold standard for treating BBSs involves the periodic insertion of plastic stents at intervals of 3-4 months, spanning a course of approximately one year. Unfortunately, stent occlusion emerges as a prevalent issue within this treatment paradigm, leading to the recurrence of symptoms and necessitating repeated ERCPs. In response to this clinical concern, we initiated a pilot study, delving into the microbial composition present in bile and on the inner surfaces of plastic stents. This investigation encompassed 22 patients afflicted by BBSs who had previously undergone ERCP with plastic stent placement. Our preliminary findings offered promising insights into the microbial culprits behind stent occlusion, with Enterobacter and Lactobacillus spp. standing out as prominent bacterial species known for their biofilm-forming tendencies on stent surfaces. These revelations hold promise for potential interventions, including targeted antimicrobial therapies aimed at curtailing bacterial growth on stents and the development of advanced stent materials boasting anti-biofilm properties.

Background and study aims: Characterization of indeterminate biliary strictures (IDBS) still represents a major challenge. Digital single-operator cholangioscopy (DSOC) could potentially overcome limits of conventional biopsy and brush sampling. The aim of this study was to compare diagnostic accuracy of visual evaluation and DSOC-guided biopsies to conventional trans-papillary sampling techniques and to evaluate the inter-observer agreement (IOA) on visual diagnosis. Patients and methods: All consecutive patients undergoing DSOC-guided biopsy after conventional sampling techniques for IDBS during a six-year period were retrospectively evaluated. Final diagnosis was based on histological evaluation of the surgical specimen if available or a clinical follow-up of at least 6 months. For IOA, 20-second DSOC clips were retrospectively reviewed by 6 experts and 6 trainees and classified according to the Monaco Classification. Results: Thirty-five patients underwent DSOC for IDBS in the study period; 14 patients (F = 9) with a median age of 64 years (range 53-76) met the study aim. After DSOC, strictures location was changed in three patients (additional yield of 21.4 %). Intraductal DSOC-guided biopsy were technically successful in all cases, with an adequacy of 92.8 %. No adverse events were recorded. Final diagnosis was benign disease in five cases and cholangiocarcinoma in the others. For IOA, 29 videos were evaluated with almost perfect agreement for final diagnosis (kappa 0.871; agreement 93.1, p <0.001), although overall accuracy of DSOC visual finding was 73.6 % and 64.4 % for experts and trainees, respectively. Conclusions: DSOC could improve diagnostic accuracy for IDBS, since it showed high sensitivity for visual finding and high specificity for DSOC guided-biopsy. Visual diagnosis seems reliable for diagnosis using the Monaco Classification.

Background/objectives: Insulinomas are rare, functioning pancreatic neuroendocrine neoplasms (pNEN), whose gold standard therapy is surgical resection. Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) is a recent technique that has emerged as a minimally invasive therapeutic option for patients with pancreatic lesions not eligible for surgery. In this study, we aimed to describe a series of patients with unresectable pancreatic insulinoma treated with EUS-RFA. Methods: This is a single-center, retrospective study including all consecutive patients with functioning pancreatic insulinoma undergoing EUS-RFA for surgical unfitness or surgery refusal, between March 2017 and September 2021. Technical success (i.e., complete mass ablation), adverse event rate and severity, clinical and radiologic outcomes (i.e., symptom remission with a normal concentration of blood glucose, and the presence of intralesional necrosis), and post-procedural follow-up were assessed. Results: A total of 10 patients (mean age: 67.1 ± 10.1years; F:M 7:3) were included. The mean size of insulinoma was 11.9 ± 3.3 mm. Technical success and clinical remission were achieved in 100% of patients. Only one (10%) patient was successfully treated with two RFA sessions. Two procedure-related early adverse events occurred, including two (20%) cases of mild abdominal pain. No major complications were observed. The complete radiologic response within 3 months after EUS-RFA was observed in all patients (100%). After a median follow-up of 19.5 (range12-59) months, symptom remission and persistent euglycemia were assessed in all the patients. Conclusions: Data from this case series suggest that EUS-RFA is a feasible and safe therapeutic approach for pancreatic insulinomas in patients unwilling or unable to undergo surgery with medium-term efficacy.

Considering the scientific evidence nowadays available, we suggest that IPFD should be carefully differentiated between pancreatic fat accumulation (an overflow of fat in the pancreas in patients with adipose excess) and fatty replacement (characterized by a change in the cellular identity with an acinar-to-adipocyte transdifferentiation in patients with pancreatic damage, such as AP). Different from the conclusions of the authors of this study, we believe that fatty replacement is not the “first hit” predisposing to pancreatic disease, but the “second hit” driving to pancreatic meta-inflammation and chronic damage (Figure 1).

Background Both weight regain and dumping syndrome (DS) after Roux-en-Y gastric bypass (RYGB) have been related to the dilation of gastro-jejunal anastomosis. The aim of this study is to assess the safety and long-term efficacy of endoscopic transoral outlet reduction (TORe) for DS and/or weight regain after RYBG.Materials and Methods A retrospective analysis was performed on a prospective database. Sigstad's score, early and late Arts Dumping Score (ADS) questionnaires, absolute weight loss (AWL), percentage of total body weight loss (%TBWL), and percentage of excess weight loss (%EWL) were assessed at baseline and at 6, 12, and 24 months after TORe.Results Eighty-seven patients (median age 46 years, 79% female) underwent TORe. The median baseline BMI was 36.2 kg/m(2). Out of 87 patients, 58 were classified as "dumpers " due to Sigstad's score & GE; 7. The resolution rate of DS (Sigstad's score < 7) was 68.9%, 66.7%, and 57.2% at 6, 12, and 24 months after TORe, respectively. A significant decrease in Sigstad's score as well as in early and late ADS questionnaires was observed (p < 0.001). The median Sigstad's score dropped from 15 (11-8.5) pre-operatively to 2 (0-12) at 24 months. The %TBWL was 10.5%, 9.9%, and 8.1% at 6, 12, and 24 months, respectively. Further, "dumpers " with resolution of DS showed better weight loss results compared with those with persistent DS (p < 0.001). The only adverse event observed was a perigastric fluid collection successfully managed conservatively.Conclusion TORe is a minimally invasive treatment for DS and/or weight regain after RYGB, with evidence of long-term efficacy.

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Objective: Peroral endoscopic myotomy (POEM) has become standard treatment for achalasia with comparable efficacy to surgery. In most of published series, the length of myotomy is 12-13 cm. Shorter cuts could have the advantage of shorter procedure time and possibly reduced gastro-oesophageal reflux disease (GORD) rate. Design: This single-centre, patient-blinded, randomised, non-inferiority clinical trial included 200 patients, who were randomly allocated, to receive either a long-POEM (13 cm; 101 patients) or a short-POEM (8 cm; 99 patients). Primary outcome was defined as an Eckardt symptom score of ≤3 at 24 months after the procedure; a non-inferiority design was chosen with an accepted success range of 6% between the two treatments. Secondary outcomes included operating time, complication rate, postoperative manometry, GORD rate and quality of life. Results: In the intention-to-treat analysis, clinical success rates were 89.1% in the long-POEM and 98.0% in the short-POEM group, resulting in an absolute between-group difference of -8.9% (90% CI -14.5 to -3.3).Procedure time was significantly reduced in the short-POEM as compared with the long-POEM group (40 vs 50 min, p<0.0001). Severe adverse events occurred in one patient in both groups.No differences were observed in postoperative GORD: acid exposure >6% on pH monitoring study at 6 months was seen in 34.3% (long-POEM) vs 31.1% (short-POEM), while endoscopic oesophagitis was diagnosed in 37.6% vs 51.5% at 6 months and in 21% vs 24.5% at 24 months. Regular proton pump inhibitor use was not different either (36.8% vs 37.5%). Conclusions: Our study demonstrates non-inferiority of a shorter cut length of POEM as compared with the standard treatment, which saved some procedural time. GORD rate was not reduced by reducing cutting length. Trial registration number: NCT03450928.

We read with deep interest the position paper from the Italian Association of Hospital Gastroenterologists and Digestive Endoscopists (AIGO) reviewing the environmental impact of gastroenterology and digestive endoscopy. Interestingly the position paper provides information on the carbon footprint of gastroenterology and particularly digestive endoscopy. Impressively, gastroenterology is considered the third largest contributor to waste production in healthcare. ERCP accounts only for the 8% of procedures performed, it accounts for more than 30% of waste generated. This result can be explained because ERCP is frequently performed under general anesthesia generating therefore more waste, and because during ERCP a large number of disposable devices (guidewires, cannulotomes, balloons, baskets etc.) is used if compared with other endoscopic procedures.

Complete hypopharyngeal stenosis is rare and challenging to treat. A 72-year-old man underwent total laryngectomy with bilateral radical neck dissection, total thyroidectomy, and pectoralis major myocutaneous flap reconstruction to treat laryngeal cancer. Following adjuvant radiotherapy, the patient developed an hypopharyngeal stenosis. This was initially treated with endoscopic dilations. However, after 3 years, stricture recurrence led to complete obstruction of the hypopharyngeal lumen that required placement of a percutaneous endoscopic gastrostomy tube for nutrition. After failure of endoscopic ultrasound-guided recanalization, an endoscopic magnetic compression anastomosis was attempted

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic procedure that might lead to severe adverse events. Post-ERCP pancreatitis (PEP) is the most common post-procedural complication, which is related to significant mortality and increasing healthcare costs. Up to now, the prevalent approach to prevent PEP consisted of employing pharmacological and technical expedients that have been shown to improve post-ERCP outcomes, such as the administration of rectal nonsteroidal anti-inflammatory drugs, aggressive intravenous hydration, and the placement of a pancreatic stent. However, it has been reported that PEP originates from a more complex interaction of procedural and patient-related factors. Appropriate ERCP training has a pivotal role in PEP prevention strategy, and it is not a chance that a low PEP rate is universally considered one of the most relevant indicators of proficiency in ERCP. Scant data on the acquisition of skills during the ERCP training are currently available, although some efforts have been recently done to shorten the learning curve by way of simulation-based training and demonstrate competency by meeting technical requirements as well as adopting skill evaluation scales. Besides, the identification of adequate indications for ERCP and accurate pre-procedural risk stratification of patients might help to reduce PEP occurrence regardless of the endoscopist’s technical abilities, and generally preserve safety in ERCP. This review aims at delineating current preventive strategies and highlighting novel perspectives for a safer ERCP focusing on the prevention of PEP.

Nowadays, stenting malignant biliary stenosis (extrahepatic or hilar), benign biliary stenosis, and pancreatic duct stenosis in chronic pancreatitis as well as stenting for prophylaxis of post- endoscopic retrograde cholangiopancreatography pancreatitis and for failed extraction of biliary stones or endoscopic papillectomy are the many common challenges for a bilio-pancreatic endoscopist. The purpose of this review is to provide a practical approach to bilio-pancreatic stenting indications and techniques. Having a thorough understanding of stenting indications and techniques, for a bilio-pancreatic endoscopist means being able to develop a tailored approach for each clinical scenario depending on the type of stent used. Biliary stents, in fact, vary in diameter, length, and composition, making it possible to give each patient personalized treatment.

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Background/objectives: Insulinomas are rare, functioning pancreatic neuroendocrine neoplasms (pNEN), whose gold standard therapy is surgical resection. Endoscopic ultrasound-guided radiofrequency abla-tion (EUS-RFA) is a recent technique that has emerged as a minimally invasive therapeutic option for patients with pancreatic lesions not eligible for surgery. In this study, we aimed to describe a series of patients with unresectable pancreatic insulinoma treated with EUS-RFA.Methods: This is a single-center, retrospective study including all consecutive patients with functioning pancreatic insulinoma undergoing EUS-RFA for surgical unfitness or surgery refusal, between March 2017 and September 2021. Technical success (i.e., complete mass ablation), adverse event rate and severity, clinical and radiologic outcomes (i.e., symptom remission with a normal concentration of blood glucose, and the presence of intralesional necrosis), and post-procedural follow-up were assessed.Results: A total of 10 patients (mean age: 67.1 & PLUSMN; 10.1years; F:M 7:3) were included. The mean size of insulinoma was 11.9 & PLUSMN; 3.3 mm. Technical success and clinical remission were achieved in 100% of pa-tients. Only one (10%) patient was successfully treated with two RFA sessions. Two procedure-related early adverse events occurred, including two (20%) cases of mild abdominal pain. No major complica-tions were observed. The complete radiologic response within 3 months after EUS-RFA was observed in all patients (10 0%). After a median follow-up of 19.5 (range12-59) months, symptom remission and persistent euglycemia were assessed in all the patients.Conclusions: Data from this case series suggest that EUS-RFA is a feasible and safe therapeutic approach for pancreatic insulinomas in patients unwilling or unable to undergo surgery with medium-term efficacy.& COPY; 2023 IAP and EPC. Published by Elsevier B.V. All rights reserved.

Background: The optimal small bowel preparation modality before capsule endoscopy (SBCE) is still uncertain, regarding preparation type, dose and timing of administration. Aim: The aim of the study is to evaluate the small bowel cleansing in patients undergoing small bowel capsule endoscopy after fasting alone or active treatment with purgative solutions. Methods: We searched 4 major scientific databases from inception to December 2021 for studies evaluating small bowel preparation before SBCE. Different preparation efficacy was compared using fasting as reference. Main variables evaluated in the current study were: preparation type, administration schedule and timing. Results: 17 studies (27 treatment arms) with 2372 patients (male 47,4%) were included, mean age 54 years. Fasting alone VS overall purgative preparations pooled rate difference (RD) was 0.15 I2=81.5% p: 0.000. Sub-analysis for preparation schedule (day-before, split and same-day) and the time lapse showed that administration of PEG after the ingestion of capsule had the highest rate of adequate small bowel cleansing with a RD 0.33, administration between 1 and 6 h before SBCE had a RD 0.28, 6 to 12 h had a RD 0.21 and ≥12 h had a RD 0.05. Conclusions: Timing of ingestion was found to be critical for bowel cleansing; the shorter time laps between the ingestion last dose of laxative and SBCE, the better was the mucosal visualization.

Intraductal biliary lesions can involve the main hepatic confluence. Assessment of the extension of pedunculated biliary lesions during per-oral cholangioscopy (POCS) can optimize and personalize the surgical strategy. Four consecutive cases of pedunculated biliary lesions were analysed. Cholangioscopy was performed with a disposable single-operator cholangioscope. POSC was successfully performed in four patients (three female, mean age 50 years), showing involvement of the main biliary confluence in three of four pedunculated biliary lesions; direct biopsy sampling was diagnostic in two of three cases (in one patient, biopsy were not performed due to the smooth appearance of the intrabiliary lesion). No adverse events occurred after POCS. Surgery required excision of the main hepatic confluence in two of three cases (one patient was not resectable). POCS can diagnose intrabiliary extension of protruding biliary lesions, providing important information to plan the surgical intervention.

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Hundreds of millions of operations are performed worldwide each year, and the rising uptake in minimally invasive surgery has enabled fiber optic cameras and robots to become both important tools to conduct surgery and sensors from which to capture information about surgery. Computer vision (CV), the application of algorithms to analyze and interpret visual data, has become a critical technology through which to study the intraoperative phase of care with the goals of augmenting surgeons' decision-making processes, supporting safer surgery, and expanding access to surgical care. While much work has been performed on potential use cases, there are currently no CV tools widely used for diagnostic or therapeutic applications in surgery. Using laparoscopic cholecystectomy as an example, we reviewed current CV techniques that have been applied to minimally invasive surgery and their clinical applications. Finally, we discuss the challenges and obstacles that remain to be overcome for broader implementation and adoption of CV in surgery.

Obesity is a chronic, relapsing disease representing a global epidemic. To date, bariatric surgery is the most effective treatment for morbid obesity in the long-term. Roux-en-Y gastric bypass (RYGB) is one of the most performed bariatric interventions, with excellent long-term outcomes. However, about one-third of patients may experience weight regain over time, as well as dumping syndrome. Both these conditions are challenging to manage and require a multidisciplinary and personalized approach. The dilation of the gastro-jejunal anastomosis is a recognized etiological factor for both weight regain and dumping syndrome. Dietary modifications, behavioral interventions, and medications represent the first therapeutic step. Revisional surgery is the traditional approach when non-invasive treatments fail. However, re-interventions may be technically difficult and are associated with increased morbidity and mortality. Transoral outlet reduction (TORe) is an endoscopic procedure aimed at reducing the size of the anastomosis and is proposed as a minimally invasive treatment of weight regain and/or dumping syndrome refractory to conservative therapies. This review is aimed at providing a narrative overview of the role of TORe as part of the multidisciplinary therapeutic toolkit nowadays available to approach weight regain and dumping syndrome after RYGB.

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With the aging of the population and the epidemic spread of obesity, the frequency of older individuals with obesity is steadily growing. To date, no data evaluating the use of endoscopic sleeve gastroplasty (ESG) in the elderly have been published. In this case series, we evaluate the short- and medium-term outcomes of ESG in patients with obesity aged 65 years and older.

Background: The incidence of ampullary tumors is increasing but data on association with an increased exposure to certain risk factors are scanty. Objective: To investigate risk and protective factors associated with the occurrence of ampullary tumors and whether these factors differ between ampullary tumors of the intestinal and pancreatobiliary subtypes or between adenomas and carcinomas. Methods: The association between a large set of exposome features and ampullary tumors occurrence was investigated in a bi-centric case-control study after ethic committee approval and power calculation. Results: In 223 histologically confirmed patients and 446 controls, previous cholecystectomy (odd ratio [OR] = 2.07; 95% confidence interval [CI] = 1.34-3.20) and proton pump inhibitors use (OR = 1.66; 95% CI = 1.16-2.37) were associated with increased risk of ampullary tumors, aspirin use (OR = 0.57; 95% CI = 0.36-0.90) and light alcohol intake (OR = 0.54; 95% CI = 0.38-0.76) with reduced risk. A previous cholecystectomy was also associated with tumors of intestinal subtype and with both adenomas and carcinomas, and proton pump inhibitors use with adenomas only. Smoking, body mass index, family history of cancers, previous ulcer, diabetes and use of statins, insulin and metformin were not significant factors. Conclusion: This is the first case-control study specifically highlighting factors associated with the occurrence of ampullary tumors. We report factors that are novel and plausible, in keeping with mechanisms described for other gastrointestinal tumors and with potential clinical relevance.

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Background Endoscopic mucosal resection and submucosal dissection (ESD) are treatments of choice for superficial neoplastic colorectal lesions. Only a few studies have compared these techniques. Aim To compare the efficacy and safety of endoscopic piecemeal mucosal resection (EPMR), ESD and hybrid-endoscopic submucosal dissection (H-ESD) of large colorectal lesions in a Western endoscopic center. Methods This is a retrospective analysis on a prospective medical database of consecutive colorectal superficial lesions larger than 20 mm, resected by EPMR, ESD or H-ESD collected from 2015 to 2019. Results Two hundred twenty-nine colorectal lesions were included. All lesions were completely endoscopically resected, 65.9% by EPMR, 19.7% by ESD and 14.4% by H-ESD. Endoscopic control after the index procedure was available for 86.5% patients. Among these patients, 80% had a second follow-up colonoscopy. The overall recurrence rate was 13.2, 0 and 6.1% for EPMR, ESD and H-ESD respectively, with a significant difference between EPMR and ESD. All recurrences were endoscopically treated during follow-up procedures. Risk of complications was not significantly different between the three groups. Conclusions EPMR, ESD and H-ESD are effective and safe procedures. Recurrence rate in EPMR was higher but can be managed endoscopically with high success rates. EPMR is faster and technically simpler so should be considered a potential first-line therapy for colorectal superficial neoplastic lesions.

Benign biliary strictures (BBS) can be associated with several causes, with postoperative and inflammatory strictures representing the most common ones. Endoscopy represents nowadays the first-line treatment in the management of BBS. Endoscopic balloon dilatation, plastic stents placement, fully covered metal stent placement, and magnetic compression anastomosis are the endoscopic techniques available for the treatment of BBS. The aim of this study is to perform a review of the literature to assess the role of endoscopy in the management of BBS and to evaluate the application of the different procedures in the different clinical settings

Fully covered self-expanding metal stents (FCSEMS) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection, FCSEMS design, efficacy and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain.

Background and study aims Endoscopic drainage of benign biliary and pancreatic strictures can be challenging, especially when tightness of the stenosis does not allow passage of mechanical and pneumatic dilation catheters. Electroincision of benign biliopancreatic can be considered in selected cases.Patients and methods Three male patients (mean age 33 years, range 9-60) underwent endoscopic retrograde cholangiopancreatography to drain anastomotic biliary stricture (ABS) following orthotopic liver transplantation (n =2) and pancreatic duct stenosis due to abdominal trauma (n= 1). The biliopancreatic strictures could be passed only with a thin 0.020-inch hydrophilic guidewire. Conventional mechanical and pneumatic dilators failed to pass the strictures due to weakness of the guidewire. Therefore, electrosurgical incision by over-the-wire 6Fr cystotome or needle-knife was attempted using pure cut current.Results The two cases of ABS were approached also by cholangioscopy and the 6Fr cystotome easily passed the strictures, allowing subsequent pneumatic dilatation and insertion of multiple plastic stents. The patient with a pancreatic duct stricture underwent electrosurgical incision using a thin needle knife over-the-wire, resulting in insertion of a 7Fr pancreatic stent. No adverse events occurred; all the patients were discharged within 24 to 48 hours.

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 (R) (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.

Background: Endoscopic sleeve gastroplasty (ESG) is an incisionless procedure that reduces the size of the gastric cavity. In prior studies, it has been proven to be a safe and effective treatment for obesity. In this study, we performed a collaborative study to evaluate the effectiveness of ESG among new endobariatric programs.Methods: This was an international, multicenter study reviewing the outcomes of ESG in centers starting ESG programs. Total body weight loss, change of body mass index (BMI), excess body weight loss (EBWL), technical success, duration of hospitalization, and immediate and delayed adverse events and complications at 24 h, 1 week, and 1, 3, and 6 months post-procedure were evaluated.Results: A total of 91 patients (35 males) from six centers were included. The patients' mean BMI before the procedure was 38.7 kg/m(2). BMI reduction at 3 months was 7.3 (p <0.0001, at 6 months 9.3 (p< 0.000), and at 12 months 8.6 (p< 0.000) from baseline. EBWL was 17.3% at 1 month (p < 0.000), 29.2% at 3 months (p < 0.000), and 35.6% at 6 months (p < 0.000). The mean procedure duration was 85.1 min. The mean length of hospital stay post-procedure was 27 h.Conclusion: ESG provides EBWL percentage sustained up to 12 months. These results are equivalent among the new ESG centers compared to previous studies by expert centers.

Background and aim: Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications. Methods: This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications. Results: D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal. Conclusion: D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.

Background and study aim: The traditional endoscopic therapy of anastomotic strictures (AS) after orthotopic liver transplantation (OLT) is multiple ERCPs with insertion of an increasing number of plastic stents side-by-side. Fully covered self-expanding metal stents (cSEMS) could be a valuable option to decrease the number of procedures needed or non-responders to plastic stents. This study aims to retrospectively analyze the results of AS endoscopic treatment by cSEMS and to identify any factors associated to its success. Patients and Methods Ninety-one patients (mean age 55.9 ± 7.6 DS; 73 males) from 9 Italian transplantation centers, had a cSEMS positioned for post-OLT AS between 2007 and 2017. 49 (54%) patients were treated with cSEMS as a second-line treatment. Results All the procedures were successfully performed without with no immediate complications. After ERCP, adverse events occurred in 11% of cases (2 moderate pancreatitis, 8 cholangitis). In 49 patients (54%) cSEMSs migrated. After cSEMS removal, 46 patients (51%) needed further endoscopic (45 patients) or radiologic (1 patient) treatments to solve the AS. Lastly, 7 patients underwent surgery. Multivariable stepwise logistic regression showed that cSEMS migration was the only factor associated with further treatments (OR 2.6, 95% CI 1.0-6.6; p-value 0.03); cSEMS implantation before 12 months from OLT was associated with stent migration (OR 5.2, 95% CI 1.7-16.0; p-value 0.004). Conclusions cSEMS appears to be a safe tool to treat AS. cSEMS migration is the main limitation to its routinary implantation and needs to be prevented, probably with the use of new generation anti-migration stents.

Objective Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D).Design Eligible patients (haemoglobin A1c (HbA1c) 59-86 mmol/mol, body mass index >= 24 and <= 40 kg/m(2), fasting insulin >48.6 pmol/L, >= 1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks.Results Overall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was -10.4 (18.6) mmol/mol in DMR group versus -7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was -5.4 (5.6)% in DMR group versus -2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was -6.6 mmol/mol (17.5 mmol/mol) versus -3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was -5.4% (6.1%) versus -2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)>= 10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient.Conclusions DMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcohol

Objective: To develop a deep learning model to automatically segment hepatocystic anatomy and assess the criteria defining the critical view of safety (CVS) in laparoscopic cholecystectomy (LC). Background: Poor implementation and subjective interpretation of CVS contributes to the stable rates of bile duct injuries in LC. As CVS is assessed visually, this task can be automated by using computer vision, an area of artificial intelligence aimed at interpreting images. Methods: Still images from LC videos were annotated with CVS criteria and hepatocystic anatomy segmentation. A deep neural network comprising a segmentation model to highlight hepatocystic anatomy and a classification model to predict CVS criteria achievement was trained and tested using 5-fold cross validation. Intersection over union, average precision, and balanced accuracy were computed to evaluate the model performance versus the annotated ground truth. Results: A total of 2854 images from 201 LC videos were annotated and 402 images were further segmented. Mean intersection over union for segmentation was 66.6%. The model assessed the achievement of CVS criteria with a mean average precision and balanced accuracy of 71.9% and 71.4%, respectively. Conclusions: Deep learning algorithms can be trained to reliably segment hepatocystic anatomy and assess CVS criteria in still laparoscopic images. Surgical-technical partnerships should be encouraged to develop and evaluate deep learning models to improve surgical safety.

Esophageal fistula is a life-threatening condition caused by several types of injuries (iatrogenic, traumatic, postoperative, and Boerhaave syndrome), requiring complex and multidisciplinary management. To date, no clear guidelines have been drawn up for the treatment, which may include a conservative, minimally invasive, or major surgical approach (ie, esophagectomy), depending on the patient’s specific clinical characteristics. The mortality rate exceeds 50%, particularly in the case of a delayed diagnosis.1

Background and study aims The aim of this study was to assess long-term clinical outcomes beyond 6 years in patients who underwent per-oral endoscopic myotomy (POEM) for the treatment of achalasia.Patients and methods Patients with achalasia who underwent POEM between 2010 and 2012 and had follow-up of at least 6 years were retrospectively identified at eight tertiary care centers. The primary outcome evaluated was clinical success defined by an Eckardt symptom score (ESS) <= 3 for the duration of the follow-up period. The clinical success cohort was compared to failure (ESS >3 at any time during follow-up) in order to identify characteristics associated with symptom relapse. The incidence of patient-reported gastroesophageal reflux (GER) was also evaluated.Results Seventy-three patients with 6-year follow-up data were identified. Sustained clinical remission was noted in 89% (65/73) at 6-years. Mean ESS decreased from 7.1 +/- 2.3 pre-procedure to 1.1 +/- 1.1 at 6 years (P<0.001). Symptomatic reflux was reported by 27 of 72 patients (37.5%). Type I achalasia (OR 10.8, P=0.04) was found to be associated with clinical failure on logistic regression analysis.Conclusions In patients with achalasia, POEM provides high initial clinical success with excellent long-term outcomes. There are high rates of patient-reported gastro-esophageal reflux post-procedure which persist at long-term follow-up.

Background and study aims The need for hospital beds during the COVID-19 pandemic almost overwhelmed the health care systems all over the world. Therefore, elective non-life-saving procedures were postponed. We decided to perform all colorectal endoscopic mucosal dissections (ESDs) for challenging lesions as outpatient procedures, organizing an ad hoc path to management of any delayed post-procedural complications. The aim of the present study was to retrospectively evaluate the feasibility and safety of outpatient ESD for colorectal tumors. Patients and methods From March 2020 to May 2020, outpatient colorectal ESDs were performed for 15 challenging lesions. We retrospectively investigated feasibility and safety of the procedures, rates of en bloc resection, and complications rates. Results The mean age of the patients was 66.5 years and 40% of the them were on antiplatelet/anticoagulation therapy. Median size of removed lesions was 45mm (range 32-77) and 38mm (range 24 to 55) Five patients (33%) had rectal tumors extending to the dentate line and four (26.6%) were recurrences on a scar of previous endoscopic or surgical local resections. All complications, such as bleeding or visible microperforation, were managed endoscopically and no delayed perforations occurred. One patient had fever (37.5 degrees C), while three patients complained of anal pain after ESD for a rectal tumor that extended to the dentate line (RTDL); all patients were managed conservatively. Conclusion Outpatient colorectal ESD is feasible and safe for challenging lesions. It reduces costs of hospitalization but direct access to the endoscopy service to manage potential post-ESD complications should always be guaranteed.

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Background Endoscopic Submucosal Dissection (ESD) is the treatment of choice of superficial neoplastic gastrointestinal lesions. Delayed bleedings and perforations are still current clinical concerns. Glubran 2 is a synthetic cyanoacrylate-derived glue nowadays already widely used as an effective tissue adhesive. ENDONEB is a novel device thought for enabling the sealant nebulization over a specific targeted surface during laparotomy, laparoscopy, and thoracotomy. The aim of this single-center preclinical animal trial is to evaluate the feasibility and safety of the same nebulization technique during ESD in the perspective that further clinical studies would demonstrate the efficacy of Glubran 2 in preventing post-ESD adverse events. Methods Four live Landrace pigs were enrolled. Two approximately 30-mm-wide gastric ESDs were performed in each pig (experimental ESD and control ESD). About 0.5 mL of Glubran 2 was nebulized on the experimental ESDs. Subjective perception of the feasibility of the Glubran 2 nebulization was reported. Pigs were clinically monitored at follow-up and upper GI endoscopy was performed at 24 and 48 hours, when animals were euthanized to perform a macroscopic and histological analysis of the specimens. Results No peri-procedural adverse events were reported. Glubran 2 nebulization over experimental ESDs showed to be technically easy and time-effective. Clinical and endoscopic animal monitoring was negative at follow-up. At 24 hours, the Glubran 2 film was clearly visible on the eschar of the ESDs and signs of initial hydrolysis were discernable at 48 hours. No signs of peritoneal reaction were observed at the macroscopic examination. Equal transmural inflammation was described at the histological examination of both types of ESDs. Conclusions Safety and feasibility profiles of Glubran 2 nebulizing ENDONEB device over ESD surfaces were excellent. Further evidences and human trials are needed to investigate its effectiveness in ESDs' eschars se

Weight regain following primary bariatric surgery occurs in a significant proportion of patients and is attributed to epidemiological, anatomical and metabolic factors. Surgical revision of these patients has significant risks and limited benefits. Endoscopic revisions that reduce gastric pouch size and diameter of the gastrojejunal anastomosis may offer an effective, safe, less invasive and even reproducible treatment. We herein discuss the indication, selection and feasibility of different endoscopic techniques that could be used in the management of weight regain following primary bariatric surgery. Future research could optimize a personalized approach not only in the endoscopic management but also in combination with other therapeutic modalities for weight regain after bariatric surgery.

Obesity is a chronic, relapsing disease representing a major global health problem in the 21st century. Several etiologic factors are involved in its pathogenesis, including a Western hypercaloric diet, sedentariness, metabolic imbalances, genetics, and gut microbiota modification. Lifestyle modifications and drugs often fail to obtain an adequate and sustained weight loss. To date, bariatric surgery (BS) is the most effective treatment, but only about 1% of eligible patients undergo BS, partly because of its negligible morbidity and mortality. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive, endoscopic, bariatric procedure, which proved to be safe and effective. In this review, we aim to examine evidence supporting the role of a personalized and multidisciplinary approach, guided by a multidisciplinary team (MDT), for obese patients undergoing ESG, from patient selection to long-term follow-up. The cooperation of different health professionals, including an endocrinologist and/or obesity medicine physician, a bariatric surgeon, an endoscopist experienced in bariatrics, a registered dietitian, an exercise specialist, a behaviour coach, a psychologist, and a nurse or physician extender, aims to induce radical and sustained lifestyle changes. We also discussed the relationship between gut microbiota and outcomes after bariatric procedures, speculating that the characterization of gut microbiota before and after ESG may help develop new tools, including probiotics, to optimize weight loss outcomes.

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Background and study aims Current data show that traditional training methods in endoscopic retrograde cholangiopancreatography (ERCP) fall short of producing competent trainees. We aimed to evaluate whether a novel approach to simulator-based training might improve the learning curve for novice endoscopists training in ERCP.Methods We conducted a multicenter, randomized controlled trial using a validated mechanical simulator (the Bokoski-Costamagna trainer). Trainees with no experience in ERCP received either standard cannulation training or motion training before undergoing standard cannulation training on the mechanical simulator. Trainees were timed and graded on their performance in selective cannulation of four different papilla configurations.Results Thirty-six trainees (16 in the motion training group, 20 in the standard group) performed 720 timed attempts at cannulating the bile duct on the simulator. Successful cannulation was achieved in 698 of 720 attempts (96.9%), with no significant difference between the two study groups ( P =0.37). Trainees in the motion training group had significantly lower median cannulation times compared to the standard group (36 vs. 48 seconds, P =0.001) and better technical performance on the first papilla type ( P =0.013).Conclusions Our findings suggest that motion training could be an innovative method aimed at accelerating the learning curve of novice trainees in the early phase of their training. Future studies are needed to establish its role in ERCP training programs.

Background: With the increasing use of extended-criteria donor organs, the interest around T-tubes in liver transplantation (LT) was restored whilst concerns regarding T-tube-related complications persist. Aim: To describe insertion and removal protocols implemented at our institution to safely use pediatric rubber 5-French T-tubes and subsequent outcomes in a consecutive series of adult patients. Methods: Data of consecutive adult LT patients from brain-dead donors, treated from March 2017 to December 2019, were collected (i.e., biliary complications, adverse events, treatment after T-Tube removal). Patients with upfront hepatico-jejunostomy, endoscopically removed T-tubes, those who died or received retransplantation before T-tube removal were excluded. Results: Seventy-two patients were included in this study; T-tubes were removed 158 d (median; IQR 128-206 d) after LT. In four (5.6%) patients accidental T-tube removal occurred requiring monitoring only; in 68 (94.4%) patients Nelaton drain insertion was performed according to our protocol, resulting in 18 (25%) patients with a biliary output, subsequently removed after 2 d (median; IQR 1-4 d). Three (4%) patients required endoscopic retrograde cholangiopancreatography (ERCP) due to persistent Nelaton drain output. Three (4%) patients developed suspected biliary peritonitis, requiring ERCP with sphincterotomy and nasobiliary drain insertion (only one revealing contrast extravasation); no patient required percutaneous drainage or emergency surgery. Conclusion: The use of pediatric rubber 5-French T-tubes in LT proved safe in our series after insertion and removal procedure refinements.

Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is a complex procedure with a relatively high rate of adverse events. Data on training of operators and fulfillment of quality indicators in Italy are scarce. The goal of this study was to assess the overall quality of ERCP in Italy compared to international standards.Patients and methods This was a prospective, observational study from different Italian centers performing ERCP. Operators answered a questionnaire, then recorded data on ERCPs over a 1-to 3-month period.Results Nineteen Italian centers participated in the study. The most common concern of operators about training was the lack of structured programs. Seven/19 centers routinely used conscious sedation for ERCP. Forty-one experienced operators and 21 trainees performed 766 ERCPs: a successful deep biliary cannulation in native-papilla patients was achieved in 95.1% of cases; the post-ERCP pancreatitis (PEP) rate was 5.4% in native-papilla patients; cholangitis rate was 1.0%; bleeding and perforation occurred in 2.7% and 0.4% of the patients, respectively.Conclusions This study revealed that, overall, ERCP is performed in the participating Italian centers meeting good quality standards, but structured training and sedation practice are still subpar. The bleeding and perforation rate slightly exceeded the American Society of Gastrointestinal Endoscopy indicator targets but they are comparable to the reported rates from other international surveys.

Background and study aims Intraductal extension of ampullary adenoma represents a challenging endoscopic issue. Intraductal radiofrequency ablation (RFA) has been recently suggested, but evidence and standardization of this technique are still lacking. This study aimed to provide a long-term evaluation of clinical efficacy and safety of intraductal RFA ablation with a standardized algorithm of treatment. Patients and methods Data were prospectively collected from consecutive patients with intraductal extension of adenomatous ampullary lesions from January 2016 to November 2018. Endpoints of the study were clinical success evaluated on histology results at the last follow-up, technical success, and adverse events assessment. Results Nine patients with intraductal (biliary ± pancreatic) extension of ampullary adenomas were treated with RFA during the study period. Histology on the papillectomy specimen confirmed intraductal involvement with lowgrade dysplasia (LGD) in five cases (56%), high-grade dysplasia (HGD) in three (33%), and HGD with intramucosal adenocarcinoma in one patient (11 %). Additional argon plasma coagulation to ablate the adenoma on the duodenal mucosa was applied in five patients (56%). Technical success was 100 %. One patient (11%) with failed pancreatic stenting, developing acute pancreatitis after RFA, recovered with medical therapy. After a median follow-up of 21 months (IQR 20–31), six patients (67%) achieved clinical success being free of recurrence, whereas one was diagnosed with persistence of adenocarcinoma, one with recurrent HGD, and one with recurrent LGD. Conclusions In our experience, intraductal RFA achieved acceptable results after a 2-year follow-up. Further studies are required to confirm our results and to select those patients most likely to respond.

BACKGROUND & AIMS: Benign biliary strictures (BBS) are complications of chronic pancreatitis (CP). Endotherapy using multiple plastic stents (MPS) or a fully covered self-expanding metal stent (FCSEMS) are acceptable treatment options for biliary obstructive symptoms in these patients.METHODS: Patients with symptomatic CP-associated BBS enrolled in a multicenter randomized noninferiority trial comparing 12-month treatment with MPS versus FCSEMS. Primary outcome was stricture resolution status at 24 months, defined as absence of restenting and 24-month serum alkaline phosphatase not exceeding twice the level at stenting completion. Secondary outcomes included crossover rate, numbers of ERCPs and stents, and stent- or procedure-related serious adverse events (SAEs).RESULTS: Eighty-four patients were randomized to MPS and 80 to FCSEMS. Baseline technical success was 97.6% for MPS and 98.6% for FCSEMS. Eleven patients crossed over from MPS to FCSEMS, and 10 from FCSEMS to MPS. For MPS vs. FCSEMS respectively, stricture resolution status at 24 months was 77.1% (54/70) vs. 75.8% (47/62) (P=0.008 for noninferiority ITT analysis), mean number of ERCPs was 3.9±1.3 vs. 2.6±1.3 (P<0.001, ITT), and mean number of stents placed was 7.0±4.4 vs. 1.3±0.6 (P<0.001, as-treated). SAEs occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P=0.568), including cholangitis/fever/jaundice (9 vs. 7 patients respectively), abdominal pain (5 vs. 5), cholecystitis (1 vs. 3) and post-ERCP pancreatitis (0 vs. 2). No stent- or procedure-related deaths occurred.CONCLUSIONS: Endotherapy of CP-associated BBS has similar efficacy and safety for 12-month treatment using MPS compared to a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256).

Laparoscopic sleeve gastrectomy (LSG) is the current standard for bariatric surgery, but it is affected by several postoperative complications. Endoscopic sleeve gastroplasty (ESG) was created as a less invasive alternative to LSG. However, its efficacy and safety compared with LSG is unclear.

Background: and study aims Pancreatic neuroendocrine tumors (pNETs) can be difficult to detect intra-operatively. The aim of this paper is to evaluate the safety and efficacy of preoperative endoscopic ultrasound guided fine needle tattooing (EUS-FNT) to facilitate intra-operative detection of pNETs. Patients and methods: Sixteen patients with pNETs (8 insulinoma and 8 non-functional pancreatic neuroendocrine tumors) underwent EUS-FNT. The procedure was carried out using the conventional curvilinear EUS. Tattooing was performed by intralesional injection of 1-2 mL of Spot® ink (Spot®, GI Supply, Comp Hill, PA, US) using a standard 22 gauge EUS-FNA needle. Results: All identified pNETs could be tattooed in one session. The procedure was well tolerated in all patients without any complication. The time interval between tattooing and surgery was between 1 and 565 days (mean of 52 days). Nine patients underwent open and seven laparoscopic surgery. The tattooed lesions could be recognized in all but one patient. In one patient, a small hematoma secondary to the EUS-FNT was observed. Pathological examination of the resection specimen showed local R0 resection in all cases, and no interference with the specimen evaluation was encountered. Conclusions: Our results suggest that EUS-guided FNT is a safe and useful method to mark preoperatively small (≤ 2 cm) pNETs.

Background and study aims Laparoscopic sleeve gastrectomy (LSG) is the current standard for bariatric surgery, but it is affected by several postoperative complications. Endoscopic sleeve gastroplasty (ESG) was created as a less invasive alternative to LSG. However, its efficacy and safety compared with LSG is unclear.Materials and methods Relevant publications were identified in MEDLINE/Cochrane/EMBASE/OVID/ PROSPERO and NIH up to January 2020. Studies were selected that included obese patients with a baseline body mass index (BMI) between 30 and 40kg/m(2) with a minimum of 12 months of follow-up and with reported incidence of complications. The mean difference in percentage of excess weight loss (%EWL) at 12 months between LSG and ESG represented the primary endpoint. We also assessed the difference in pooled rate of adverse events. The quality of the studies and heterogeneity among them was analyzed.Results Sixteen studies were selected for a total of 2188 patients (LSG: 1429; ESG: 759) with a mean BMI 34.34 and 34.72 kg/m(2) for LSG and ESG, respectively. Mean %EWL was 80.32% (+/- 12.20; 95% CI; P = 0.001; I-2 = 98.88) and 62.20% (+/- 4.38; 95% CI; P = 0.005; I-2 = 65.52) for the LSG and ESG groups, respectively, corresponding to an absolute difference of 18.12% (+/- 0.89; 95% CI, P = 0.0001). The difference in terms of mean rate of adverse events was 0.19% (+/- 0.37; 95 %CI;. 2 = 1.602; P = 0.2056).Conclusions Our analysis showed a moderate superiority of LSG versus ESG. No difference in terms of safety was shown between the two groups. ESG is a less-invasive, repeatable and reversable and acceptable option for mild-moderate obese patients.