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Per oral endoscopic myotomy (POEM) has emerged as a preferred approach for the treatment of idiopathic achalasia and various esophageal motility disorders, offering a minimally invasive alternative to traditional laparoscopic Heller's myotomy. Over the past decade, POEM has solidified its status as the primary therapeutic choice in these conditions through constant improvements. Its evolution has been marked by continuous progress, driven by the integration of innovative technologies and sophisticated techniques. Notable advancements in the techniques include the advent of shorter myotomies and sling fiber-preserving gastric myotomies. The introduction of novel image-enhanced endoscopic techniques, such as red dichromatic imaging and much safer bipolar devices, promises to enhance safety and reduce the technical demands of the POEM procedure. Furthermore, significant strides have been made in understanding gastroesophageal reflux (GERD) following POEM, enabling the differentiation of "true reflux" from acidification resulting from fermentation through manual pH tracing assessment. This distinction aids in identifying cases necessitating treatment with proton pump inhibitors. Other treatment strategies of post-POEM GERD have expanded to the incorporation of NOTES fundoplication and device-assisted fundoplication if the necessity arises. This comprehensive review delves into recent developments in POEM, encompassing technical variations, the assessment and management of post-POEM reflux, outcomes in special populations, and future prospects. By exploring these facets, we aim to provide a comprehensive overview of the current state of POEM, shedding light on its evolution and the promising directions it is poised to take in the field of third-space endoscopy.
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BACKGROUND AND AIMS: GERD is common after peroral endoscopic myotomy (POEM). Selective sparing of oblique fibers may reduce the incidence of reflux esophagitis after POEM. In this study, we compared the incidence of GERD between conventional myotomy (CM) versus oblique fiber-sparing (OFS) myotomy in patients with achalasia. METHODS: Eligible patients with type I and II achalasia who underwent POEM from January 2020 to October 2020 were randomized into 2 groups (CM and OFS myotomy). Exclusion criteria were type III achalasia, sigmoid esophagus, and history of Heller's myotomy. The primary study outcome was incidence of reflux esophagitis (at least grade B) in the 2 groups. Secondary outcomes were reflux symptoms, esophageal acid exposure, clinical success, and adverse events. RESULTS: One hundred fifteen patients were randomized into CM (n = 58) and OFS myotomy (n = 57) groups. POEM was technically successful in all patients. Overall, reflux esophagitis was found in 56 patients (48.7%). The incidence of at least grade B esophagitis was similar in both groups (CM vs OFS myotomy: 25.9% vs 31.6%, P = .541). The mean number of reflux episodes (48.2 ± 36.6 vs 48.9 ± 40.3, P = .933), increased esophageal acid exposure >6% (45.5% vs 31.7%, P = .266), and high DeMeester scores (38.6% vs 41.5%, P = .827) were similar in both groups. There was no difference in the rate of symptomatic reflux (GERD questionnaire score >7) or use of proton pump inhibitors at 1 year. CONCLUSIONS: Sparing of sling fibers has no significant impact on the incidence of significant reflux esophagitis after POEM. Novel strategies need to be explored to prevent reflux after POEM. (Clinical trial registration number: NCT04229342.).
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Acalasia Esofágica , Esofagite Péptica , Refluxo Gastroesofágico , Miotomia , Cirurgia Endoscópica por Orifício Natural , Humanos , Acalasia Esofágica/complicações , Esofagite Péptica/epidemiologia , Esofagite Péptica/etiologia , Esofagite Péptica/prevenção & controle , Cárdia/cirurgia , Cirurgia Endoscópica por Orifício Natural/efeitos adversos , Refluxo Gastroesofágico/epidemiologia , Refluxo Gastroesofágico/etiologia , Refluxo Gastroesofágico/prevenção & controle , Miotomia/efeitos adversos , Resultado do Tratamento , Esfíncter Esofágico Inferior/cirurgiaRESUMO
BACKGROUND: Endoscopic ultrasound (EUS)-guided drainage of walled-off necrosis (WON) using either plastic or metal stents is the mainstay of WON management. Our single-center randomized controlled trial aimed to evaluate the efficacy of biflanged metal stents (BFMSs) and plastic stents for WON drainage. METHODS: Patients with symptomatic WON amenable to EUS-guided drainage were randomized to receive either BFMSs or plastic stents. The primary outcome was reintervention-free clinical success at 4 weeks. Secondary outcomes were: overall clinical success (complete resolution of symptoms and significant reduction in size of WON [<50% of original size and <5 cm in largest diameter at 4-week follow-up]); number of reinterventions; adverse events (AEs); hospital stay for first admission; and medium-term outcomes at 6 months (recurrence, disconnected pancreatic duct, chronic pancreatitis, and new-onset diabetes mellitus). RESULTS: 92 patients were randomized: 46 in each arm. The reintervention-free clinical success rate was significantly higher in the BFMS group on intention-to-treat analysis (67.4% vs. 43.5%; P = 0.02). Overall clinical success at 1 month was similar in both groups. There were significantly fewer reinterventions (median 0 [IQR 0-1] vs. 1 [0-2]; P = 0.03) and shorter hospital stays in the BFMS group (7.0 [SD 3.4] vs. 9.1 [5.5] days; P = 0.04). There were no differences in procedure-related AEs, mortality, or medium-term outcomes. CONCLUSIONS: BFMSs provide better reintervention-free clinical success at 4 weeks, with shorter hospital stay and without increased risks of AEs, compared with plastic stents for EUS-guided drainage of WON. Medium-term outcomes are however similar for both stent types.
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BACKGROUND: Extracorporeal shockwave lithotripsy (ESWL) and/or endoscopic retrograde cholangiopancreatography (ERCP) are recommended as first-line therapy for painful uncomplicated chronic pancreatitis with obstructed main pancreatic duct (MPD) in the pancreas head/body. However, predictors of pain relief after ESWL are unknown. We evaluated independent predictors of persistent pain in patients who underwent ESWL for chronic pancreatitis. METHODS: 640 consecutive adult patients with chronic pancreatitis, who underwent successful ESWL with ERCP and pancreatic duct (PD) stent placement, were followed for 12 months. The pain was assessed at baseline and at 12 months using the Izbicki Pain Score, with a score decrease of >50% considered pain relief. Independent predictors of pain relief were derived from logistic regression analysis. RESULTS: Of 640 patients (mean age 36.71 [SD 12.19] years; 60.5% men), 436 (68.1%) had pain relief and 204 (31.9%) had persistent pain. On univariate analysis, older age, male sex, alcohol and tobacco intake, longer duration of symptoms, dilated MPD and MPD stricture were associated with persistent pain at 12 months (P<0.05). Consumption of alcohol (odds ratio [OR] 1.93, 95%CI 1.26-2.97), tobacco (OR 4.09, 95%CI 2.43-6.90), duration of symptoms (OR 1.02, 95%CI 1.01-1.04), MPD size (OR 1.22, 95%CI 1.11-1.33), and MPD stricture (OR 8.50, 95%CI 5.01-14.42) were independent predictors of persistent pain. CONCLUSIONS: Alcohol, tobacco, duration of symptoms, MPD size and stricture were independent predictors of persistent pain after successful ESWL. A multidisciplinary team approach that includes behavioral therapy and surgical options should be considered for such patients.
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Colangiopancreatografia Retrógrada Endoscópica , Litotripsia , Pancreatite Crônica , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor Abdominal/etiologia , Consumo de Bebidas Alcoólicas/efeitos adversos , Calcinose/terapia , Calcinose/etiologia , Cálculos/terapia , Cálculos/complicações , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversos , Litotripsia/efeitos adversos , Litotripsia/métodos , Medição da Dor , Ductos Pancreáticos , Pancreatite Crônica/complicações , Pancreatite Crônica/terapia , Fatores de Risco , StentsRESUMO
BACKGROUND AND AIM: Motorized spiral enteroscopy (MSE) has recently been introduced for small bowel evaluation. In this systematic review and meta-analysis, we aim to evaluate the safety and efficacy of MSE for evaluation of small bowel diseases. METHODS: A literature search was performed in Embase, PubMed, Medline databases for studies evaluating MSE between January -2010 and October-2022. The primary outcome of the study was diagnostic yield with MSE. Secondary outcomes included technical success, procedure duration, depth of maximum insertion (DMI), rate of pan-enteroscopy and adverse events. RESULTS: 10 studies with 961 patients [581 (60.5%) males] were included in the analysis. 1068 MSE procedures were performed by antegrade route in 698, retrograde route in 215 and bidirectional in 155 patients. Technical success was achieved in 94.9% (95% CI 92.9% to 96.4%) procedures. The pooled diagnostic yield of MSE was 73.7% (95% CI 70.7% to 76.4%). Pooled rate of pan-enteroscopy by antegrade route was 21.9% (95% CI 18.1% to 26.1%), retrograde route was 6.9% (95% CI 2.4% to 18.3%) and combined route was 61.2% (95% CI 52.4% to 69.3%). Pooled rate of major adverse events was 1.9% (95% CI 1.2% to 3.2%). CONCLUSIONS: MSE is a safe and effective tool for evaluating small bowel disorders. High diagnostic yield and low rate of adverse events make it a potential alternative to balloon enteroscopy. However, comparative trials are required in the future.
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Enteropatias , Laparoscopia , Masculino , Humanos , Feminino , Enteropatias/diagnóstico , Enteropatias/etiologia , Endoscopia Gastrointestinal/efeitos adversos , Endoscopia Gastrointestinal/métodos , Intestino Delgado , Enteroscopia de Duplo Balão/efeitos adversosRESUMO
Gastrointestinal (GI) endoscopy is among the highest waste generator in healthcare facilities. The major reasons include production of large-volume non-renewable waste, use of single-use devices, and reprocessing or decontamination processes. Single-use endoscopic accessories have gradually replaced reusable devices over last two decades contributing to the rising impact of GI endoscopy on ecosystem. Several reports of infection outbreaks with reusable duodenoscopes raised concerns regarding the efficacy and adherence to standard disinfection protocols. Even the enhanced reprocessing techniques like double high-level disinfection have not been found to be the perfect ways for decontamination of duodenoscopes and therefore, paved the way for the development of single-use duodenoscopes. However, the use of single-use endoscopes is likely to amplify the net waste generated and carbon footprint of any endoscopy unit. Moreover, single-use devices challenge one of the major pillars of sustainability, that is, "reuse." In the era of climate change, a balanced approach is required taking into consideration patient safety as well as financial and environmental implications. The possible solutions to provide optimum care while addressing the impact on climate include selective use of disposable duodenoscopes and careful selection of accessories during a case. Other options include use of disposable endcaps and development of effective high-level disinfection techniques. The collaboration between the healthcare professionals and the manufacturers is paramount for the development of environmental friendly devices with low carbon footprint.
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Mudança Climática , Ecossistema , Humanos , Contaminação de Equipamentos/prevenção & controle , Endoscópios , Duodenoscópios , Desinfecção/métodos , Endoscopia GastrointestinalRESUMO
BACKGROUND AND AIM: Resection for Crohn's disease (CD) related strictures is definitive but carries risk of morbidity, recurrence, and short bowel syndrome. On the contrary, the durability of endotherapy (ET) for CD-related strictures is questionable. Prospective comparative studies are limited. We aimed to prospectively compare the outcomes of ET in CD strictures with a case-matched surgical therapy (ST) cohort. METHODS: Patients undergoing ET or resection for primary CD strictures (symptomatic, non-traversable, < 5 cm length, n ≤ 3) between January 2021 and March 2022 in a high-volume tertiary center were compared with regard to recurrent symptoms, escalation of therapy, re-intervention, and re-operation based on propensity matched analysis. RESULTS: Fifty-nine patients [49% ET, 57.6% male, median (years): 34 (15-74)] had ≥ 12 months of follow up. Before propensity matching, cumulative re-intervention rate was significantly higher with ET [34.5% (10/29) vs 3.3% (1/30) ST, P = 0.002]. Recurrent symptoms (34.5% vs 26.7%, P = 0.42), escalation of medical therapy (27.5% vs 23.3%, P = 0.64), and re-operation (7.4% vs 3.1%, P = 0.55) were comparable. In propensity matched analysis adjusted for demographics, disease, and stricture characteristics [n = 42, 21 each, 62% male, median (years): 32 (15-60)], cumulative probability of re-intervention rates was higher in ET (28.6% vs 4.8%, P = 0.042). The cumulative probability of recurrent symptoms (ET: 33.3% vs surgery 33.3%, P = 0.93), therapy escalation (ET: 23.8% vs surgery 28.6%, P = 0.75), and re-operation (ET: 9.5% vs surgery 4.8%, P = 0.57) was similar. CONCLUSIONS: ET for CD strictures require higher re-interventions compared with resection although re-operation could be avoided in the majority with comparable symptom free survival at 1 year.
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Doença de Crohn , Obstrução Intestinal , Humanos , Masculino , Feminino , Doença de Crohn/complicações , Doença de Crohn/cirurgia , Constrição Patológica/etiologia , Constrição Patológica/cirurgia , Estudos Prospectivos , Obstrução Intestinal/etiologia , Obstrução Intestinal/cirurgia , Resultado do Tratamento , Dilatação , Estudos Retrospectivos , Endoscopia GastrointestinalRESUMO
OBJECTIVES: Endoscopic full-thickness resection (EFTR) is emerging as an effective modality for mucosal and submucosal lesions in the colorectum. In this systematic review and meta-analysis, we aimed to analyze the success and safety of device-assisted EFTR in the colon and rectum. METHODS: A literature search was performed in the Embase, PubMed, and Medline databases for studies evaluating device-assisted EFTR between inception to October 2022. The primary outcome of the study was clinical success (R0 resection) with EFTR. Secondary outcomes included technical success, procedure duration, and adverse events. RESULTS: In all, 29 studies with 3467 patients (59% male patients, 3492 lesions) were included in the analysis. The lesions were located in right colon (47.5%), left colon (28.6%), and rectum (24.3%). EFTR was performed for subepithelial lesions in 7.2% patients. The pooled mean size of the lesions was 16.6 mm (95% confidence interval [CI] 14.9-18.2, I2 98%). Technical success was achieved in 87.1% (95% CI 85.1-88.9%, I2 39%) procedures. The pooled rate of en bloc resection was 88.1% (95% CI 86-90%, I2 47%) and R0 resection was 81.8% (95% CI 79-84.3%, I2 56%). In subepithelial lesions, the pooled rate of R0 resection was 94.3% (95% CI 89.7-96.9%, I2 0%). The pooled rate of adverse events was 11.9% (95% CI 10.2-13.9%, I2 43%) and major adverse events requiring surgery was 2.5% (95% CI 2.0-3.1%, I2 0%). CONCLUSION: Device-assisted EFTR is a safe and effective treatment modality in cases with adenomatous and subepithelial colorectal lesions. Comparative studies are required with conventional resection techniques, including endoscopic mucosal resection and submucosal dissection.
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Adenoma , Ressecção Endoscópica de Mucosa , Humanos , Masculino , Feminino , Ressecção Endoscópica de Mucosa/métodos , Colo/patologia , Resultado do Tratamento , Reto/cirurgia , Reto/patologia , Adenoma/cirurgia , Estudos RetrospectivosRESUMO
The human microbiome is a diverse consortium of microbial kingdoms that play pivotal roles in host health and diseases. We previously reported a dysbiotic bacteriome in chronic pancreatitis patients with diabetes (CPD) compared with patients with it's nondiabetic (CPND) phenotype. In this study, we extended our exploration to elucidate the intricate interactions between the mycobiome, bacteriome, and hosts' plasma metabolome with the disease phenotypes. A total of 25 participants (CPD, n = 7; CPND, n = 10; healthy control, n = 8) were recruited for the study. We observed elevated species richness in both the bacterial and fungal profiles within the CP diabetic cohort compared to the nondiabetic CP phenotype and healthy control cohorts. Notably, the CP group displayed heterogeneous fungal diversity, with only 40% of the CP nondiabetic patients and 20% of the CP diabetic patients exhibiting common core gut fungal profiles. Specific microbial taxa alterations were identified, including a reduction in Bifidobacterium adolescentis and an increase in the prevalence of Aspergillus penicilloides and Klebsiella sp. in the disease groups. In silico analysis revealed the enrichment of pathways related to lipopolysaccharide (LPS), apoptosis, and peptidase, as well as reduced counts of the genes responsible for carbohydrate metabolism in the CP groups. Additionally, distinct plasma metabolome signatures were observed, with CPD group exhibiting higher concentrations of sugars and glycerolipids, while the CPND cohort displayed elevated levels of amino acids in their blood. The fatty acid-binding protein (FABP) concentration was notably greater in the CPD group than in the HC group (4.220 vs. 1.10 ng/ml, p = 0.04). Furthermore, compared with healthy controls, disease groups exhibited fewer correlations between key fungal taxa (Aspergillus sp., Candida sp.) and bacterial taxa (Prevotella copri, Bifidobacteria sp., Rumminococcaceae). Our study unveils, for the first time, a dysbiotic mycobiome and emphasizes unique host bacterial-mycobial interactions in CP patient with diabetes, potentially influencing disease severity. These findings provide crucial insights for future mechanistic studies aiming to unravel the determinants of disease severity in this complex clinical context. Supplementary Information: The online version contains supplementary material available at 10.1007/s12088-024-01207-8.
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OBJECTIVE: Recent studies have shown that motorised spiral enteroscopy (MSE) enables deeper and total small bowel evaluation compared with single-balloon enteroscopy (SBE) in suspected Crohn's disease (CD) when analysed per procedure. However, no randomised controlled study has compared bidirectional MSE with bidirectional SBE in suspected CD. DESIGN: Patients with suspected CD requiring small bowel enteroscopy were randomly assigned to either SBE or MSE between May 2022 and September 2022 in a high volume tertiary centre. Bidirectional enteroscopy was done if intended lesion could not be reached on unidirectional study. Comparison was made with regard to technical success (ability to reach lesion), diagnostic yield, depth of maximal insertion (DMI), procedure time and total enteroscopy rates. Depth:time ratio was calculated to avoid confounding for the location of lesion. RESULTS: Among 125 suspected patients with CD (28% female, 18-65 years, median 41 years), 62 and 63 underwent MSE and SBE, respectively. The overall technical success (98.4 %: MSE, 90.5 %: SBE; p=0.11), diagnostic yield (95.2%: MSE; 87.3%: SBE, p=0.2) and procedure time were not significantly different. However, MSE appeared to have higher technical success (96.8% vs 80.7%, p=0.08) in deeper small bowel (distal jejunum/proximal ileum) with higher DMI, higher depth:time ratio and total enteroscopy rates when attempted (77.8% vs 11.1%, p=0.0007). Both the modalities were safe although minor adverse events were more common with MSE. CONCLUSION: MSE and SBE have comparable technical success and diagnostic yield for small bowel evaluation in suspected CD. MSE scores over SBE with regard to deeper small bowel evaluation with complete small bowel coverage and higher depth of insertion in a shorter time. TRIAL REGISTRATION NUMBER: NCT05363930.
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Doença de Crohn , Enteropatias , Enteroscopia de Balão Único , Humanos , Feminino , Masculino , Doença de Crohn/patologia , Endoscopia Gastrointestinal/métodos , Intestino Delgado/patologia , Íleo/patologia , Enteroscopia de Duplo Balão/efeitos adversos , Enteropatias/diagnósticoRESUMO
INTRODUCTION: Device-assisted enteroscopy has revolutionized the management of small-bowel disorders (SBD). No study to date has compared both novel motorized spiral enteroscopy (NMSE) and single-balloon enteroscopy (SBE) as a randomized controlled trial. Hence, this study was planned to include patients having SBD with the primary aim to compare the total enteroscopy rate (TER). METHODS: This study was conducted at the Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India, from September 20, 2022, to December 15, 2022. All consecutive patients, older than 18 years with suspected SBD, and planned for total enteroscopy were screened for inclusion. The primary outcome was to compare the TER, and secondary outcomes were to compare the technical success, time taken to reach the depth of maximal insertion, withdrawal time, total procedure time, diagnostic yield, therapeutic success, and adverse events (AE). RESULTS: Seventy-two patients of the 110 patients screened were randomized in either NMSE (n = 35) or SBE (n = 37) group. The most common indication for the procedures was obscure gastrointestinal bleed (48%), others being unexplained abdominal pain with indeterminate radiologic findings (32%) and chronic diarrhea (20%). In NMSE group, the TER was 71.4%, whereas in the SBE group, it was 10.8% ( P < 0.0001). The total procedure time (minutes) was much lesser with NMSE (58.17 ± 21.5 minutes) vs SBE (114.2 ± 33.5 minutes) ( P < 0.0001). The diagnostic yield of NMSE (80%) was comparatively higher than SBE (62.1%) ( P = 0.096). Minor AE (grade I) were observed in both the groups: NMSE 8.5% (3/35) and SBE 5.4% (2/37). DISCUSSION: This randomized controlled trial shows that with NMSE higher TER can be achieved in shorter duration with minimal AE, compared with SBE.
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INTRODUCTION: Infected pancreatic necrosis (IPN) is a major cause of mortality in acute pancreatitis (AP). Currently, no specific strategies are available to predict the development of IPN. Earlier we reported that persistent down-regulation of HLA-DR increases risk of developing IPN. Altered kynurenine pathway (KP) metabolites showed poor prognosis in sepsis. Here we evaluated the role of HLA-DR and KP in IPN. METHODS: Patients with ANP and healthy controls were enrolled. Demographic and clinical parameters were recorded. Circulating interleukin (IL)-8, 6, 1ß, 10, Tumor necrosis factor-α were quantified using flowcytometry. Plasma procalcitonin, endotoxin, and KP (tryptophan, kynurenine) concentrations were estimated using ELISA. qRT-PCR was conducted to evaluate mRNA expression of HLA-DR, IL-10, Toll like receptor-4 (TLR-4), and kynurenine-3-monooxygenase (KMO) genes on peripheral blood mononuclear cells. Plasma metabolites were quantified using gas chromatography mass spectrometry (GC-MS/MS). Standard statistical methods were used to compare study groups. Metaboanalyst was used to analyse/visualize the metabolomics data. RESULTS: We recruited 56 patients in Cohort-1 (IPN:26,Non-IPN:30), 78 in Cohort-2 (IPN:57,Non-IPN:21), 26 healthy controls. Increased cytokines, endotoxin, and procalcitonin were observed in patients with IPN compared to Non-IPN. HLA-DR and KMO gene expressions were significantly down-regulated in IPN groups, showed positive correlation with one another but negatively correlated with IL-6 and endotoxin concentrations. Increased IDO and decreased plasma tryptophan were observed in IPN patients. Metabolome analysis showed significant reduction in several essential amino acids including tryptophan in IPN patients. Tryptophan, at a concentration of 9 mg/ml showed an AUC of 91.9 (95%CI 86.5-97.4) in discriminating IPN. CONCLUSION: HLA-DR downregulation and KP alteration are related to IPN. The KP metabolite plasma tryptophan can act as a potential biomarker for IPN.
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Cinurenina , Pancreatite Necrosante Aguda , Humanos , Cinurenina/metabolismo , Triptofano/metabolismo , Pró-Calcitonina , Espectrometria de Massas em Tandem , Doença Aguda , Leucócitos Mononucleares , Biomarcadores , Antígenos HLA-DR/genética , Quinurenina 3-Mono-Oxigenase/genética , Quinurenina 3-Mono-Oxigenase/metabolismo , Necrose , EndotoxinasRESUMO
BACKGROUND AND AIMS: Both single-balloon enteroscopy (SBE) and the novel motorized spiral enteroscopy (NMSE) are effective techniques for device-assisted enteroscopy (DAE). To date, no study has prospectively compared both modalities in suspected Crohn's disease (CD). METHODS: Patients with suspected CD undergoing either SBE or NMSE between March 2021 and December 2021 in a high-volume tertiary center were prospectively compared for technical success (ability to reach the lesion), diagnostic yield, depth of maximal insertion (DMI), procedure time, and total enteroscopy rates. RESULTS: One hundred seventy-seven patients (37.2% female; aged 7-75 years) with suspected CD underwent 201 DAEs. Technical success was 83% (SBE 81.5% vs NMSE 87.3%, P = .61) and impacted subsequent management in 92% (SBE 88.5% vs NMSE 97.8%, P = .2). Technical success with antegrade NMSE was significantly higher (81.4%) than antegrade SBE (33.3%, P = .007) for lesions in the proximal ileum and beyond. There was no significant difference in the diagnostic yield (SBE 80.8% vs NMSE 83.6%, P = .65). Median procedure time was significantly lower in both antegrade (NMSE, 40 minutes [range, 10-75]; SBE, 60 minutes [range, 20-180]; P < .0001) and retrograde (NMSE, 25 minutes [range, 20-60]; SBE, 60 minutes [range, 20-180]; P < .0001) NMSE. Median DMI was higher with antegrade NMSE (NMSE, 400 cm [range, 70-600]; SBE, 180 cm [range, 60-430]; P < .0001). The total enteroscopy rate was higher with NMSE (37% vs .7% with SBE, P < .0001). All adverse events were mild. CONCLUSIONS: Both NMSE and SBE are safe and effective for small-bowel evaluation in suspected CD. NMSE is superior to SBE with regard to deeper small-bowel evaluation with complete small-bowel coverage and shorter procedure time.
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Doença de Crohn , Enteropatias , Enteroscopia de Balão Único , Humanos , Feminino , Masculino , Doença de Crohn/diagnóstico por imagem , Estudos Prospectivos , Endoscopia Gastrointestinal/métodos , Intestino Delgado/diagnóstico por imagem , Intestino Delgado/patologia , Enteroscopia de Duplo Balão/efeitos adversos , Enteropatias/diagnósticoRESUMO
BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. METHODS: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent. RESULTS: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65). CONCLUSIONS: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.).
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Gastroenteropatias , Pancreatite Crônica , Stents Metálicos Autoexpansíveis , Humanos , Adulto , Pessoa de Meia-Idade , Idoso , Ductos Pancreáticos , Constrição Patológica/terapia , Constrição Patológica/complicações , Estudos Prospectivos , Resultado do Tratamento , Stents Metálicos Autoexpansíveis/efeitos adversos , Pancreatite Crônica/complicações , Stents/efeitos adversos , Gastroenteropatias/etiologia , Dor/etiologia , Plásticos , Colangiopancreatografia Retrógrada Endoscópica/efeitos adversosRESUMO
BACKGROUND: The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas. METHODS: 61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥â18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs). RESULTS: Among 551 patients, 236 (42.8â%) were aged >â65, 281 (51.0â%) were men, and 256 (46.5â%) had their procedure as an inpatient. ERCPs included 196 (35.6â%) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0â%) were completed: 503 (91.3â%) using only the single-use duodenoscope, and 26 (4.7â%) with crossover to a reusable endoscope. There were 22 ERCPs (4.0â%) that were not completed, of which 11 (2.0â%) included a crossover and 11 (2.0â%) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8â%), including 17 (3.1â%) who developed post-ERCP pancreatitis. CONCLUSIONS: In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.
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Colangiopancreatografia Retrógrada Endoscópica , Pancreatite , Adulto , Masculino , Humanos , Feminino , Colangiopancreatografia Retrógrada Endoscópica/métodos , Duodenoscópios/efeitos adversos , Endoscopia Gastrointestinal , Pancreatite/etiologiaRESUMO
OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) has revolutionized the treatment of many pancreaticobiliary conditions. However, little is known about the global practices, training programs, and credentialing of the procedure. The aim of the current study is to address the above questions. METHODS: This was an international cross-sectional survey conducted between October 2020 and May 2021. Participating countries were requested to complete an online survey on ERCP services and training. RESULTS: Eighty-nine countries responded to the survey. There were significant increases in the proportion of ERCP services provided by the government (P < 0.0001), number of endoscopists per million of population (P < 0.0001), and number of institutions per million of population (P < 0.0001) from low to high human development index (HDI). Eighteen percent of the countries offer the procedure as part of a standard training program, 68.5% do not follow a standardized training curriculum. Risk factors for higher incidence and mortality from pancreatic cancers include higher HDI category, smaller population, a larger number of endoscopists proficient in ERCP, and lower number of institutions providing ERCP training. Countries with very high HDI have four times higher incidence and mortality from pancreatic cancers as compared to those with low HDI. CONCLUSIONS: There is still an ongoing need for improving ERCP training in low to very high HDI countries. A structured training program is still lacking in many parts of the world. With increasing incidence and mortality of pancreatic cancers, particularly in high HDI countries, there is a need for further increasing facilities for ERCP training.
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Colangiopancreatografia Retrógrada Endoscópica , Neoplasias Pancreáticas , Humanos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Estudos Transversais , Endoscopia Gastrointestinal , Neoplasias Pancreáticas/etiologia , CurrículoRESUMO
BACKGROUND: The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN: Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. RESULTS: Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. CONCLUSION: EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER: NCT03322553.
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Esofagite Péptica , Refluxo Gastroesofágico , Adulto , Endoscopia Gastrointestinal , Feminino , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/cirurgia , Humanos , Masculino , Inibidores da Bomba de Prótons/uso terapêutico , Qualidade de Vida , Resultado do TratamentoRESUMO
OBJECTIVE: In patients with an intermediate likelihood of choledocholithiasis, European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend endoscopic ultrasound (EUS) or magnetic resonance cholangiopancreatography (MRCP) to diagnose choledocholithiasis to make the indication for endoscopic retrograde cholangiopancreatography (ERCP) treatment; there is no randomised control trial to compare both in this setting. DESIGN: Patients with suspected choledocholithiasis satisfying ESGE guideline's intermediate likelihood were screened for this single-centre randomised controlled trial between November 2019 and May 2020. The enrolled patients were randomised to either EUS or MRCP. ERCP was performed in stone positive cases or if clinical suspicion persisted during follow-up. Negative cases underwent a further 6-month clinical follow-up. Main outcome was accuracy (sensitivity/specificity) of both tests to diagnose choledocholithiasis, with ERCP or follow-up as a gold standard. RESULTS: Of 266 patients, 224 patients (mean age: 46.77±14.57 years; 50.9 % female) were enrolled; overall prevalence of choledocholithiasis was 49.6%, with a higher frequency in the MRCP group (63/112 vs 46/112 for EUS). Both sensitivity of EUS and MRCP were similarly high (92%-98%), without significant differences between the two groups. The negative predictive value and likelihood ratio + were significantly higher in EUS arm (p<0.05). The percentage of ERCPs either incorrectly halted back (false negatives: EUS: 2 vs MRCP: 5) or performed unnecessarily (false positives: EUS: 1 vs MRCP: 2) was low in both groups. CONCLUSION: The performance parameters of both EUS and MRCP are comparable for detecting choledocholithiasis in the intermediate-risk group of choledocholithiasis and the choice of a test should be based on local expertise, availability of resources and patient preference. TRIAL REGISTRATION NUMBER: NCT04173624.
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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 vs 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 endoscopic retrograde cholangiopancreatography (ERCPs) and stents, and stent- or procedure-related serious adverse events. 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 = .008 for noninferiority intention-to-treat analysis), mean number of ERCPs was 3.9 ± 1.3 vs 2.6 ± 1.3 (P < .001, intention-to-treat), and mean number of stents placed was 7.0 ± 4.4 vs 1.3 ± .6 (P < .001, as-treated). Serious adverse events occurred in 16 (19.0%) MPS and 19 (23.8%) FCSEMS patients (P = .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 with a single FCSEMS, with FCSEMS requiring fewer ERCPs over 2 years. (ClinicalTrials.gov, Number: NCT01543256.).
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Colestase/terapia , Materiais Revestidos Biocompatíveis , Drenagem/instrumentação , Pancreatite Crônica/complicações , Plásticos , Stents Metálicos Autoexpansíveis , Stents , Adulto , Idoso , Colestase/diagnóstico por imagem , Colestase/etiologia , Drenagem/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pancreatite Crônica/diagnóstico , Desenho de Prótese , Resultado do TratamentoRESUMO
INTRODUCTION: This study aimed to evaluate the role of prophylactic norfloxacin in preventing bacterial infections and its effect on transplant-free survival (TFS) in patients with acute-on-chronic liver failure (ACLF) identified by the Asian Pacific Association for the Study of the Liver criteria. METHODS: Patients with ACLF included in the study were randomly assigned to receive oral norfloxacin 400 mg or matched placebo once daily for 30 days. The incidence of bacterial infections at days 30 and 90 was the primary outcome, whereas TFS at days 30 and 90 was the secondary outcome. RESULTS: A total of 143 patients were included (72 in the norfloxacin and 71 in the placebo groups). Baseline demographics, biochemical variables, and severity scores were similar between the 2 groups. On Kaplan-Meier analysis, the incidence of bacterial infections at day 30 was 18.1% (95% confidence interval [CI], 10-28.9) and 33.8% (95% CI, 23-46) (P = 0.03); and the incidence of bacterial infections at day 90 was 46% (95% CI, 34-58) and 62% (95% CI, 49.67-73.23) in the norfloxacin and placebo groups, respectively (P = 0.02). On Kaplan-Meier analysis, TFS at day 30 was 77.8% (95% CI, 66.43-86.73) and 64.8% (95% CI, 52.54-75.75) in the norfloxacin and placebo groups, respectively (P = 0.084). Similarly, TFS at day 90 was 58.3% (95% CI, 46.11-69.84) and 43.7% (95% CI, 31.91-55.95), respectively (P = 0.058). Thirty percent of infections were caused by multidrug-resistant organisms. More patients developed concomitant candiduria in the norfloxacin group (25%) than in the placebo group (2.63%). DISCUSSION: Primary norfloxacin prophylaxis effectively prevents bacterial infections in patients with ACLF.