Over-the-scope clip as first-line treatment of peptic ulcer bleeding: a multicentre randomized controlled trial (TOP Study).

BACKGROUND: First-line over-the-scope-clip (OTSC) treatment has shown higher efficacy than standard endoscopic therapy in acute non-variceal upper gastrointestinal bleeding (UGIB) from different causes. We performed a head-to-head randomized controlled trial (RCT) comparing OTSC vs through-the-scope-clip (TTSC) as first-line mechanical treatment in the specific setting of peptic ulcer (PU) bleeding. METHODS: We conducted an international, multicenter RCT on consecutive patients with suspected UGIB. In case of Forrest Ia-IIb gastroduodenal PU, patients were randomized 1:1 to OTSC or TTSC treatment. The primary outcome was the rate of 30-day rebleeding after successful initial hemostasis. Secondary outcomes included successful initial hemostasis and overall clinical success rates, defined as the composite of successful initial hemostasis and no evidence of 30-day rebleeding. RESULTS: 251 patients were screened and 112 patients were finally randomized to OTSC (n=61) or TTSC (n=51) treatment. 30-day rebleeding rates were 1.6% (1/61) and 3.9% (2/51) for OTSC- and TTSC-treated patients, respectively (Kaplan-Meier log-rank, p = 0.458). Successful initial hemostasis rates were 98.4% (60/61) in the OTSC group and 78.4% (40/51) in the TTSC group (p=0.001). Eventually, overall clinical success rates were 96.7% (59/61) in the OTSC group and 74.5% (38/51) in the TTSC group (p=0.001). CONCLUSIONS: Low rates of 30-day rebleeding were observed after first-line endoscopic treatment of acute PU bleeding with either OTSC or TTSC. However, OTSC showed higher efficacy than TTSC in achieving successful initial hemostasis and overall clinical success.

Curative criteria for endoscopic treatment of gastric cancer.

Endoscopic treatment, particularly endoscopic submucosal dissection, has become the primary treatment for early gastric cancer. A comprehensive optical assessment, including white light endoscopy, image-enhanced endoscopy, and magnification, are the cornerstones for clinical staging and determining the resectability of lesions. This paper discusses factors that influence the indication for endoscopic resection and the likelihood of achieving a curative resection. Our review stresses the critical need for interpreting the histopathological report in accordance with clinical guidelines and the imperative of tailoring decisions based on the patients' and lesions' characteristics and preferences. Moreover, we offer guidance on managing complex scenarios, such as those involving non-curative resection. Finally, we identify future research avenues, including the role of artificial intelligence in estimating the depth of invasion and the urgent need to refine predictive scores for lymph node metastasis and metachronous lesions.

Implementación de la disección endoscópica submucosa esofágica en España: resultados del registro nacional / Implementation of esophageal endoscopic submucosal dissection in Spain: Results from the nationwide registry

Introducción y objetivos Los resultados de la disección submucosa endoscópica (DSE) en el esófago no han sido evaluados en nuestro país. Nuestro objetivo principal fue analizar la efectividad y la seguridad de la técnica. Material y métodos Análisis del registro nacional prospectivo de DSE. Se incluyeron todas las lesiones superficiales esofágicas extirpadas mediante DSE en 17 hospitales (20 endoscopistas) entre enero de 2016 y diciembre de 2021. Se excluyeron las lesiones subepiteliales. La variable principal fue el porcentaje de resección curativa. Se realizó un análisis de regresión logística para conocer los predictores de resección no curativa y un análisis de supervivencia. Resultados Se realizaron un total de 102 DSE en 96 pacientes. El éxito técnico fue del 100% y el porcentaje de resección en bloque, del 98%. El porcentaje de resección R0 y curativa fue del 77,5% (n = 79; IC 95%: 68%-84%) y del 63,7% (n = 65; IC 95%: 54%-72%), respectivamente. La histología más frecuente fue la neoplasia sobre esófago de Barrett (n = 55 [53,9%]). El principal motivo de resección no curativa fue la invasión submucosa profunda (n = 25). Los centros con menor volumen de casos obtuvieron cifras inferiores de resección curativa. El porcentaje de perforación, sangrado diferido y estenosis posprocedimiento fue del 5%, del 5% y del 15,7%, respectivamente. Ningún paciente falleció ni requirió cirugía por un efecto adverso. Tras una mediana de seguimiento de 14 meses, 20 pacientes (20,8%) recibieron cirugía y/o quimio-radioterapia, y 9 fallecieron (mortalidad del 9,4%). Conclusiones En nuestro medio, la DSE esofágica es curativa en aproximadamente dos de cada tres pacientes, con un riesgo aceptable de efectos adversos (AU)

Introduction and aims The outcomes of endoscopic submucosal dissection (ESD) in the esophagus have not been assessed in our country. Our primary aim was to analyze the effectiveness and safety of the technique. Material and methods Analysis of the prospectively maintained national registry of ESD. We included all superficial esophageal lesions removed by ESD in 17 hospitals (20 endoscopists) between January 2016 and December 2021. Subepithelial lesions were excluded. The primary outcome was curative resection. We conducted a survival analysis and used logistic regression analysis to assess predictors of non-curative resection. Results A total of 102 ESD were performed on 96 patients. The technical success rate was 100% and the percentage of en-bloc resection was 98%. The percentage of R0 and curative resection was 77.5% (n = 79; 95% CI: 68%-84%) and 63.7% (n = 65; 95% CI: 54%-72%), respectively. The most frequent histology was Barrett-related neoplasia (n = 55 [53.9%]). The main reason for non-curative resection was deep submucosal invasion (n = 25). The centers with a lower volume of ESD obtained worse results in terms of curative resection. The rate of perforation, delayed bleeding and post-procedural stenosis were 5%, 5% and 15.7%, respectively. No patient died or required surgery due to an adverse effect. After a median follow-up of 14 months, 20 patients (20.8%) underwent surgery and/or chemoradiotherapy, and 9 patients died (mortality 9.4%). Conclusions In Spain, esophageal ESD is curative in approximately two out of three patients, with an acceptable risk of adverse events (AU)

Perspectives and awareness of endoscopy healthcare professionals on sustainable practices in gastrointestinal endoscopy: results of the LEAFGREEN survey.

BACKGROUND: Gastrointestinal (GI) endoscopy is one of healthcare's main contributors to climate change. We aimed to assess healthcare professionals' attitudes and the perceived barriers to implementation of sustainable GI endoscopy. METHODS: The LEAFGREEN web-based survey was a cross-sectional study conducted by the European Society of Gastrointestinal Endoscopy (ESGE) Green Endoscopy Working Group. The questionnaire comprised 39 questions divided into five sections (respondent demographics; climate change and sustainability beliefs; waste and resource management; single-use endoscopes and accessories; education and research). The survey was available via email to all active members of the ESGE and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) in March 2023. RESULTS: 407 respondents participated in the survey (11% response rate). Most participants (86%) agreed climate change is real and anthropogenic, but one-third did not consider GI endoscopy to be a significant contributor to climate change. Improvement in the appropriateness of endoscopic procedures (41%) and reduction in single-use accessories (34%) were considered the most important strategies to reduce the environmental impact of GI endoscopy. Respondents deemed lack of institutional support and knowledge from staff to be the main barriers to sustainable endoscopy. Strategies to reduce unnecessary GI endoscopic procedures and comparative studies of single-use versus reusable accessories were identified as research priorities. CONCLUSIONS: In this survey, ESGE and ESGENA members acknowledge climate change as a major threat to humanity. Further improvement in sustainability beliefs and professional attitudes, reduction in inappropriate GI endoscopy, and rational use of single-use accessories and endoscopes are critically required.

Implementation of esophageal endoscopic submucosal dissection in Spain: Results from the nationwide registry. / Implementación de la disección endoscópica submucosa esofágica en España: resultados del registro nacional.

INTRODUCTION AND AIMS: The outcomes of endoscopic submucosal dissection (ESD) in the esophagus have not been assessed in our country. Our primary aim was to analyze the effectiveness and safety of the technique. MATERIAL AND METHODS: Analysis of the prospectively maintained national registry of ESD. We included all superficial esophageal lesions removed by ESD in 17 hospitals (20 endoscopists) between January 2016 and December 2021. Subepithelial lesions were excluded. The primary outcome was curative resection. We conducted a survival analysis and used logistic regression analysis to assess predictors of non-curative resection. RESULTS: A total of 102 ESD were performed on 96 patients. The technical success rate was 100% and the percentage of en-bloc resection was 98%. The percentage of R0 and curative resection was 77.5% (n=79; 95%CI: 68%-84%) and 63.7% (n=65; 95%CI: 54%-72%), respectively. The most frequent histology was Barrett-related neoplasia (n=55 [53.9%]). The main reason for non-curative resection was deep submucosal invasion (n=25). The centers with a lower volume of ESD obtained worse results in terms of curative resection. The rate of perforation, delayed bleeding and post-procedural stenosis were 5%, 5% and 15.7%, respectively. No patient died or required surgery due to an adverse effect. After a median follow-up of 14months, 20patients (20.8%) underwent surgery and/or chemoradiotherapy, and 9 patients died (mortality 9.4%). CONCLUSIONS: In Spain, esophageal ESD is curative in approximately two out of three patients, with an acceptable risk of adverse events.

Clinical outcomes of anti-reflux mucosal ablation for gastroesophageal reflux disease: An international bi-institutional study.

BACKGROUND AND AIM: Anti-reflux mucosal ablation (ARMA) is an emerging endoscopic treatment aimed at enhancing the gastroesophageal junction flap valve. This study aimed to evaluate its feasibility, effectiveness, and safety. METHODS: Between May 2018 and December 2022, patients with gastroesophageal reflux disease (GERD) symptoms refractory to acid suppression medications or those dependent on such medications were enrolled for ARMA. This retrospective analysis utilized prospectively collected data from an international bi-center study. GERD questionnaire, upper endoscopy, and 24-h pH monitoring were conducted at 2-6 months and 12 months post-ARMA. Clinical success was defined as a > 50% reduction in a validated GERD questionnaire. RESULTS: A total of 68 patients underwent ARMA. Definitive GERD was diagnosed in 44 (64.7%) patients, while 24 (35.3%) exhibited reflux hypersensitivity. Clinical success rates at 2-6 months and 1 year post-ARMA were 60% (39/65) and 70% (21/30), respectively. The median GERD-health-related quality of life score significantly improved from 26 to 11 at 2-6 months (P < 0.001). Among the 51 patients (71.8%) who underwent 24-h pH monitoring, the median acid exposure time decreased from 5.3% to 0.7% (P = 0.003), accompanied by a significant reduction in esophagitis rates (P < 0.001). Multivariate analysis did not identify predictors of short-term success. Nine (13.2%) patients experienced transient stenosis requiring balloon dilation. CONCLUSIONS: ARMA demonstrates both technical feasibility and reproducibility as a safe procedure that effectively ameliorates GERD symptoms in approximately two-thirds of patients during short-term follow up. Both reflux hypersensitivity and confirmed GERD patients, regardless of their response to acid suppression medication, may be suitable candidates.

Western outcomes of circumferential endoscopic submucosal dissection for early esophageal squamous cell carcinoma.

BACKGROUND AND AIMS: Circumferential endoscopic submucosal dissection (cESD) in the esophagus has been reported to be feasible in small Eastern case series. We assessed the outcomes of cESD in the treatment of early esophageal squamous cell carcinoma (ESCC) in Western countries. METHODS: We conducted an international study at 25 referral centers in Europe and Australia using prospective databases. We included all patients with ESCC treated with cESD before November 2022. Our main outcomes were curative resection according to European guidelines and adverse events. RESULTS: A total of 171 cESDs were performed on 165 patients. En bloc and R0 resections rates were 98.2% (95% confidence interval [CI], 95.0-99.4) and 69.6% (95% CI, 62.3-76.0), respectively. Curative resection was achieved in 49.1% (95% CI, 41.7-56.6) of the lesions. The most common reason for noncurative resection was deep submucosal invasion (21.6%). The risk of stricture requiring 6 or more dilations or additional techniques (incisional therapy/stent) was high (71%), despite the use of prophylactic measures in 93% of the procedures. The rates of intraprocedural perforation, delayed bleeding, and adverse cardiorespiratory events were 4.1%, 0.6%, and 4.7%, respectively. Two patients died (1.2%) of a cESD-related adverse event. Overall and disease-free survival rates at 2 years were 91% and 79%. CONCLUSIONS: In Western referral centers, cESD for ESCC is curative in approximately half of the lesions. It can be considered a feasible treatment in selected patients. Our results suggest the need to improve patient selection and to develop more effective therapies to prevent esophageal strictures.

Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score.

OBJECTIVE: To evaluate the risk factors for lymph node metastasis (LNM) after a non-curative (NC) gastric endoscopic submucosal dissection (ESD) and to validate and eventually refine the eCura scoring system in the Western setting. Also, to assess the rate and risk factors for parietal residual disease. DESIGN: Retrospective multicentre multinational study of prospectively collected registries from 19 Western centres. Patients who had been submitted to surgery or had at least one follow-up endoscopy were included. The eCura system was applied to assess its accuracy in the Western setting, and a modified version was created according to the results (W-eCura score). The discriminative capacities of the eCura and W-eCura scores to predict LNM were assessed and compared. RESULTS: A total of 314 NC gastric ESDs were analysed (72% high-risk resection (HRR); 28% local-risk resection). Among HRR patients submitted to surgery, 25% had parietal disease and 15% had LNM in the surgical specimen. The risk of LNM was significantly different across the eCura groups (areas under the receiver operating characteristic curve (AUC-ROC) of 0.900 (95% CI 0.852 to 0.949)). The AUC-ROC of the W-eCura for LNM (0.916, 95% CI 0.870 to 0.961; p=0.012) was significantly higher compared with the original eCura. Positive vertical margin, lymphatic invasion and younger age were associated with a higher risk of parietal residual lesion in the surgical specimen. CONCLUSION: The eCura scoring system may be applied in Western countries to stratify the risk of LNM after a gastric HRR. A new score is proposed that may further decrease the number of unnecessary surgeries.

Endoscopic Vacuum Therapy for Upper Gastrointestinal Leaks and Perforations: Analysis From a Multicenter Spanish Registry.

INTRODUCTION: Endoscopic vacuum therapy (EVT) is a novel technique for closing upper gastrointestinal (UGI) defects. Available literature includes single-center retrospective cohort studies with small sample sizes. Furthermore, evidence about factors associated with EVT failure is scarce. We aimed to assess the efficacy and safety of EVT for the resolution of UGI defects in a multicenter study and to investigate the factors associated with EVT failure and in-hospital mortality. METHODS: This is a prospective cohort study in which consecutive EVT procedures for the treatment of UGI defects from 19 Spanish hospitals were recorded in the national registry between November 2018 and March 2022. RESULTS: We included 102 patients: 89 with anastomotic leaks and 13 with perforations. Closure of the defect was achieved in 84 cases (82%). A total of 6 patients (5.9%) had adverse events related to the EVT. The in-hospital mortality rate was 12.7%. A total of 6 patients (5.9%) died because of EVT failure and 1 case (0.9%) due to a fatal adverse event. Time from diagnosis of the defect to initiation of EVT was the only independent predictor for EVT failure (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05, P = 0.005). EVT failure (OR 24.5, 95% CI 4.5-133, P = 0.001) and development of pneumonia after EVT (OR 246.97, 95% CI 11.15-5,472.58, P = 0.0001) were independent predictors of in-hospital mortality. DISCUSSION: EVT is safe and effective in cases of anastomotic leak and perforations of the upper digestive tract. The early use of EVT improves the efficacy of this technique.

POEM from A to Z: current perspectives.

The "third space endoscopy" or also called "submucosal endoscopy" is a reality we can transfer to our patients since 2010. Various modifications of the submucosal tunneling technique allow access to the submucosa or deeper layers of the gastrointestinal tract. In addition to peroral endoscopic myotomy for the treatment of achalasia, also called esophageal POEM, other variants have emerged that make it possible to treat different esophageal motility disorders, esophageal diverticula, subepithelial tumors of various locations, gastroparesis, reconnection of complete esophageal strictures or even thanks to exceptional endoscopists, pediatric disorders such as Hirschsprung's disease. Although some technical aspects are yet to be standardized, these procedures are becoming widespread worldwide and will likely become the standard treatment of these pathologies soon.

High incidence of surgery and initiation of medical therapies after colectomy for ulcerative colitis or inflammatory bowel disease unclassified.

BACKGROUND AND AIMS: Despite novel medical therapies, colectomy has a role in the management of patients with ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBDU). This study aimed to determine the incidence of unplanned surgery and initiation of immunomodulatory or biologic therapy (IMBT) after colectomy in patients with UC or IBDU, and identify associated factors. METHODS: Data of patients with preoperative diagnosis of UC or IBDU who underwent colectomy and were followed up at a single tertiary centre was retrospectively collected. The primary outcome was the risk of unplanned surgery and initiation of IMBT during follow-up after colectomy. Secondary outcomes were development of Crohn's disease-like (CDL) complications and failure of reconstructive techniques. RESULTS: 68 patients were included. After a median follow-up of 9.9 years, 32.4% of patients underwent unplanned surgery and IMBT was started in 38.2%. Unplanned surgery-free survival was 85% (95% confidence interval [CI] 73.8-91.6%) at 1 year, 76% (95% CI 63.2-84.9%) at 5 years and 69.1% (95% CI 55-79.6%) at 10 years. IMBT-free survival was 96.9% (95% CI 88.2-99.2%) at 1 year, 77.6% (95% CI 64.5-86.3%) at 5 years and 63.3% (95% CI 48.8-74.7%) at 10 years. 29.4% of patients met criteria for CDL complications. CDL complications were significantly associated to IMBT (hazard ratio 4.5, 95% CI 2-10.1). CONCLUSION: In a retrospective study, we found a high incidence of unplanned surgery and IMBT therapy initiation after colectomy among patients with UC or IBDU. These results further question the historical concept of surgery as a "definitive" treatment.

Learning curve for peroral endoscopic myotomy in therapeutic endoscopy experts and nonexperts: Large single-center experience.

OBJECTIVES: Reports on learning curve for peroral endoscopic myotomy (POEM) in therapeutic endoscopy nonexperts are limited. We aimed to assess the number of cases required to achieve POEM proficiency for endoscopic submucosal dissection (ESD) experts and nonexperts. METHODS: This is a retrospective study at the largest POEM referral center in Japan. POEM between April 2014 and December 2020 were included. Nonexperts and ESD experts were divided by training phases: A, 1-20; B, 21-40; C, 41-60; D, 61-80; and E, 81-100 cases. Primary outcome was operation time, and the phase to reach target time (83 min) was investigated. Secondary outcomes were clinical success rate, adverse events, and post-POEM gastroesophageal reflux disease (GERD). RESULTS: Five hundred and sixty-six cases were performed by 14 nonexperts, and 555 cases by 15 ESD experts. As the primary outcome, operation time in nonexperts was: A, 95 (79-115.8); B, 86.5 (71-105); C, 80 (70-100); D, 73 (64.5-100.5); and E, 73.5 (57.8-88.8) min, while in ESD experts: A, 90 (74-128); B, 77 (70-92); and C, 77 (70-93.5) min (median [interquartile range]). Operation time decreased significantly as experience increased in both groups (P < 0.001), and nonexperts required 41-60 cases to achieve proficiency, while experts required 21-40 cases. As secondary outcomes, in nonexperts, clinical success was 96.9-100%, adverse events were 5.0-9.2%, symptomatic GERD was 11.8-26.5%, and proton pump inhibitor (PPI) intake was 11.5-18.7% in each phase. While in experts, clinical success was 96.2-100%, adverse events were 3.0-5.8%, symptomatic GERD was 14.6-22.0%, and PPI intake was 12.6-17.9%. There were no significant differences among training phases. CONCLUSIONS: Non-ESD experts require more cases to achieve proficiency in POEM. These results are useful for establishing POEM training programs and institutional implementation of the procedure.

Over-the-scope-clip (OTSC®) as a rescue treatment for gastrointestinal bleeding secondary to peptic ulcer disease.

BACKGROUND AND AIMS: over-the-scope-clips (OTSC®) have been proposed as a rescue treatment for bleeding peptic ulcers. However, their effectiveness has not been evaluated in Spain. METHODS: this retrospective and single-center study (January 2018-December 2021) assessed the technical success, clinical success and safety of the device within 30 days. All patients with upper gastrointestinal bleeding due to a peptic ulcer and treated with the OTSC® clip (OVESCO) as a rescue therapy were included in the study. RESULTS: a total of eleven patients were included in the study, nine due to rebleeding and two due to persistent bleeding. Technical success was 81.9 % (9/11, confidence interval [CI] 95 %: 52-95 %). The per-protocol and intention-to-treat clinical success were 88.9 % (8/9, CI 95 %: 57-98 %) and 72.7 % (8/11, CI 95 %: 43-90 %), respectively. No device-related adverse effects were recorded. CONCLUSION: the OTSC® clip was an effective and safe rescue therapy for bleeding peptic ulcers.

Efectividad del sistema over-the-scope-clip (OTSC®) como tratamiento de rescate en la hemorragia digestiva alta secundaria a úlcera péptica / Over-the-scope-clip (OTSC®) as a rescue treatment for gastrointestinal bleeding secondary to peptic ulcer disease

Introducción: el clip OTSC® (over-the-scope-clip) se ha postulado como tratamiento de rescate de la hemorragia digestiva alta por úlcera péptica, aunque su efectividad no ha sido evaluada en nuestro medio. Métodos: en este estudio retrospectivo y unicéntrico (enero 2018-diciembre 2021) se evaluaron el éxito técnico, el éxito clínico y la seguridad del dispositivo a 30 días. Se incluyeron todos los pacientes con hemorragia digestiva alta por úlcera péptica en los que se utilizó el clip OTSC® como tratamiento de rescate. Resultados: se incluyeron once pacientes (nueve por resangrado y dos por sangrado persistente). El éxito técnico fue del 81,9 % (9/11, intervalo de confianza [IC] 95 %: 52-95 %). El éxito clínico por protocolo y por intención de tratar fue del 88,9 % (8/9, IC 95 %: 57-98 %) y del 72,7 % (8/11, IC 95 %: 43-90 %) (8/11), respectivamente. No se registraron efectos adversos relacionados con el dispositivo. Conclusiones: el clip OTSC® fue un tratamiento de rescate efectivo y seguro de la hemorragia digestiva por úlcera péptica (AU)

EUS-guided gastroenterostomy versus duodenal self-expandable metal stent for malignant gastric outlet obstruction: results from a nationwide multicenter retrospective study (with video).

BACKGROUND AND AIMS: Traditionally, palliative treatment of malignant gastric outlet obstruction (GOO) has been surgical, but surgical treatment carries significant morbidity and mortality rates. Endoscopic placement of a duodenal self-expandable metal stent (D-SEMS) has been proven to be successful for this indication in the short term. However, D-SEMSs are likely to malfunction over time. EUS-guided gastroenterostomy (EUS-GE) may help overcome these limitations. We aimed to evaluate stent failure-free survival at 3 months. METHODS: A nationwide multicenter, observational study of D-SEMS and EUS-GE procedures for patients with malignant GOO was conducted at 7 academic centers from January 2015 to June 2020. Stent failure-free survival at 1, 3, and 6 months; technical and clinical success; adverse events (AEs); and patient survival were evaluated in both groups and compared. RESULTS: Ninety-seven patients were included in the D-SEMS group and 79 in the EUS-GE group. Pancreatic cancer was the main underlying malignancy in 53.4%. No statistically significant differences regarding technical (92.8% vs 93.7%) or clinical success (83.5% vs 92.4%) were found. AE rates did not differ between groups (10.3% vs 10.1%), although 2 events in the EUS-GE group required surgical management. Patients in the EUS-GE group had improved stent patency when compared with those patients in the D-SEMS group at 3 months (92.23% vs 80.6%; adjusted hazard ratio, .37; P = .033). CONCLUSIONS: EUS-GE seems to have improved patency outcomes when compared with D-SEMS placement for palliative treatment of malignant GOO. Prospective trials are needed to fully compare their efficacy and AE profile.