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Background and study aims Data from Japanese series show that surface morphology of laterally spreading tumors (LST) in the colon identifies lesions with different incidence and pattern of submucosal invasion. Such data from western countries are scarce. We compared clinical and histological features of LST in a western country and an eastern country, with special interest on mucosal invasiveness of LST, and investigated the effect of clinical factors on invasiveness in both countries. Patients and methods Patients with LST lesions ≥20 mm were included from a multicenter prospective registry in Spain and from a retrospective registry from the National Cancer Center Hospital East, Japan. The primary outcome was the presence of submucosal invasion in LST. The secondary outcome was the presence of high-risk histology, defined as high-grade dysplasia or submucosal invasion. Results We evaluated 1102 patients in Spain and 663 in Japan. Morphological and histological characteristics differed. The prevalence of submucosal invasion in Japan was six-fold the prevalence in Spain (Prevalence Ratio PR = 5.66; 95%CI: 3.96, 8.08), and the prevalence of high-risk histology was 1.5 higher (PR = 1.44; 95%CI: 1.31, 1.58). Compared to the granular homogeneous type and adjusted by clinical features, granular mixed, flat elevated, and pseudo-depressed types were associated with higher odds of submucosal invasion in Japan, whereas only the pseudo-depressed type showed higher risk in Spain. Regarding high-risk histology, both granular mixed and pseudo-depressed were associated with higher odds in Japan, compared with only the granular mixed type in Spain. Conclusion This study reveals differences in location, morphology and invasiveness of LST in an eastern and a western cohort.

There are uncertainties concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS). The aim of this study was to determine whether a DPS within a biliary LAMS offers a potential benefit in EUS-guided CDS for the palliative management of malignant biliary obstruction. This was a multicentre retrospective study at three tertiary institutions. Period: May 2015 to August 2020. Two interventional strategies (LAMS alone and LAMS plus DPS) were compared. The choice was the endoscopist’s discretion. Inclusion: unresectable/inoperable biliopancreatic tumours with previous failed ERCP. Clinical success: bilirubin decrease > 30% at 4 weeks. Forty-one consecutive cases of EUS-CDS using biliary LAMS were treated (22 women; mean age, 72.3 years) during the study period. The procedure was technically successful in 39 (95.1%), who were managed using the two strategies (22 LAMS alone; 17 LAMS plus DPS). No differences between the groups, in terms of clinical success (77.3 vs 87.5%, p = 0.67), adverse events (AEs, 13.6 vs 11.8%, p = 0.99), recurrent biliary obstruction (RBO, 13.6 vs 23.5%, p = 0.67), or survival rate (p = 0.67) were encountered. The LAMS alone group had a shorter length of procedure (50 min vs 66 min, p = 0.102). No risk factors related to clinical success, AEs, RBO, or survival were detected. The technical variant of adding a coaxial DPS within LAMS in EUS-CDS seems not to be enough to prevent biliary morbidities, and it is a time-consuming strategy. Although prospective studies are needed, these results do not support its routine use.

Endoscopic necrosectomy through lumen apposition metal stents (LAMS) is increasingly being used for complicated walled-off pancreatic necrosis (WOPN), but the need for necrosectomy after stent placement is not well understood. The aim of this study was to evaluate clinical, endoscopic, and radiologic predictors of the need for necrosectomy in patients treated with LAMS. We retrospectively reviewed patients with WOPN treated with LAMS from 2014 to 2017. Necrosectomy was performed only in patients who had recurrent fever or hemodynamic instability during follow-up. Univariate and multivariate analyses were performed. We included 15 patients, 67% men and median age was 75 (54–76) years. Two (13%) presented adverse events, one immediate and one delayed. In the first case, the stent migrated to the gastric cavity during deployment but was relocated in the same procedure. In the second case, the patient presented bleeding on day 36 due to a pseudoaneurysm that was successfully treated with embolization. Clinical success was 100%, but five patients (33%) required endoscopic necrosectomy (4 mechanical and 1 irrigation) and one (7%) required surgical necrosectomy of distant collections. The percentage of necrosis in the collection detected in a previous CT scan (45 [35–66]% vs 10 [5–17]%) was the only factor to predict the need for necrosectomy in the multivariate analysis (OR 1.18 [1.01–1.39]). LAMS is efficient to treat WOPN but more than a third will need necrosectomy. The percentage of necrosis in the collection detected in the CT scan seems to predict the need for necrosectomy.

Electrosurgical units (ESUs) are indispensable devices in our endoscopy units. However, many endoscopists are not well-trained on their use and their physical bases are usually not properly studied or understood. In addition, comparative data concerning the settings that may be applied in different circumstances are scarce in the medical literature. Given that it is important to be aware of their strengths and risks, we conducted a review of the available information and research on this topic.

[Background and Aims]: The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models., [Methods]: A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies., [Results]: DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets., [Conclusions]: The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT 03050333.), Research support for this study was received from “La Caixa/Caja Navarra” Foundation (ID 100010434;project PR15/11100006).

Background & Aims Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection. Methods We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events. Results The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, –0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events. Conclusions In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).

We present a case-report about a patient with type II achalasia. In the high-resolution esophageal manometry (HRM), an atypical hypertensive panesophageal pressurizations were observed. Until now, the presence of hypertensive panesophageal pressurizations in type II achalasia was described in only one case-report. A POEM was performed. After the treatment, the patient presents a complete resolution of the symptoms. Control HRM showed a partial recovery of esophageal motility and the hypotonia of the gastro-esophageal junction.

Background It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. Methods/design This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to Discussion The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON. Trial registration ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home

Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) have much in common, including their main indications (biliopancreatic disorders), powerful therapeutic capacities and a steep learning curve. Over the years they have evolved from novel diagnostic procedures to interventional therapeutic techniques, but along different paths (different scopes or devices and endoscopists specializing exclusively in one or the other technique). However, EUS has gradually developed into a therapeutic technique that requires skills in the use of ERCP devices and stents, leading some ERCP specialists to explore the therapeutic potential of EUS. The corresponding literature, which has grown exponentially, includes recent experiments on combining the two techniques, which have gradually come to be used in routine care in a number of centers, with positive technical, clinical and financial outcomes. We review EUS and ERCP as individual or combined procedures for managing biliopancreatic disorders.

BACKGROUND: Data on the outcome of adverse events (AEs) and the risk of developing acute-on-chronic liver failure (ACLF) after ERCP in patients with cirrhosis are unknown. We examined the incidence and risk factors of post-ERCP AEs in patients with cirrhosis and the appearance of ACLF after ERCP. METHODS: In this multicenter, retrospective, matched-cohort study, we evaluated ERCPs performed from January 2002 to 2015. A group of patients with cirrhosis with non-ERCP interventions and one without interventions was also analyzed for the development of ACLF. RESULTS: A total of 441 ERCPs were analyzed; 158 in patients with cirrhosis (cases) and 283 in patients without cirrhosis (controls). The overall rate of AEs after all ERCPs was significantly higher in cases compared to controls (17% vs 9.5, p = 0.02). Cholangitis developed more in cases compared to controls (6.3% vs 1.8%; p = 0.01). In a subanalysis of those with sphincterotomy, the rate of bleeding was higher in those with cirrhosis (9.4% vs 3.4%; p = 0.03). Logistic regression identified cirrhosis (OR, 2.48; 95% CI, 1.36-4.53; p = 0.003) and sphincterotomy (OR, 2.66; 95% CI, 1.23-5.72; p = 0.01) as risk factors of AEs. A total of 18/158 (11.4%) cases developed ACLF after ERCP. ACLF occurred in 7/27 cases with post-ERCP AEs and in 11/131 without post-ERCP AEs (25.9% vs 8.3%; p = 0.01). A total of 3.2% (13/406) patients without interventions developed ACLF compared to 17.5% (102/580) who developed ACLF after non-ERCP interventions. Patients with decompensated cirrhosis at ERCP had a higher risk of developing ACLF (17% vs 6.8%; p = 0.04). Patients with a MELD score >= 15 were 3.1 times more likely (95% CI: 1.14-8.6; p = 0.027) to develop ACLF after ERCP. CONCLUSIONS: The rate of AEs after ERCP is higher in patients with cirrhosis compared to the non-cirrhotic population. The incidence of ACLF is higher in those with AEs after ERCP compared to those without AEs, especially cholangitis. The development of ACLF is common after ERCP and other invasive procedures. ACLF can be precipitated by numerous factors which include preceding events before the procedure, including manipulation of the bile duct, and AEs after an ERCP.

RESUMEN Este documento resume el contenido de la Guía de resección mucosa endoscópica elaborada por el grupo de trabajo de la Sociedad Española de Endoscopia Digestiva (GSEED de Resección Endoscópica) y expone las recomendaciones sobre el manejo endoscópico de las lesiones neoplásicas colorrectales superficiales. ABSTRACT This document summarizes the contents of the Clinical Guidelines for the Endoscopic Mucosal Resection of Non-Pedunculated Colorectal Lesions that was developed by the working group of the Spanish Society of Digestive Endoscopy (GSEED of Endoscopic Resection). This document presents recommendations for the endoscopic management of superficial colorectal neoplastic lesions.

Resumen Este documento resume el contenido de la Guia de reseccion mucosa endoscopica elaborada por el grupo de trabajo de la Sociedad Espanola de Endoscopia Digestiva (GSEED de Reseccion Endoscopica) y expone las recomendaciones sobre el manejo endoscopico de las lesiones neoplasicas colorrectales superficiales.

BackgroundPatients with achalasia develop a well-defined obstructive pattern of pressure in response to a rapid drink challenge test (RDC). Our aim was to determine if successful treatment of achalasia can revert the obstructive pattern of pressure in response to the RDC, and if this simple test could be useful in the follow-up of patients with achalasia. MethodsIn 26 healthy controls and 103 patients with achalasia, pressure responses to a RDC were prospectively analysed using high resolution esophageal manometry in two consecutive protocols: (a) Development study: one RDC was performed in 20 healthy controls, 63 patients with nontreated achalasia, and 21 patients with previously treated achalasia; (b) Validation study: two RDC were performed before, and 8-12weeks after treatment, in 19 patients with nontreated, newly diagnosed achalasia. Key ResultsIn the development study no healthy control, 19% of patients with previously treated achalasia and 96% of patients with nontreated achalasia developed an obstructive pressure pattern during the RDC (P3; P

Precut sphincterotomy increases the success of deep biliary cannulation, but the method fails at the initial ERCP in 5-12% of cases. Although other invasive strategies are often used to access the bile duct, a second ERCP may be effective and safe. We evaluated the efficacy, safety, and factors related to a second ERCP after failed cannulation using a precut sphincterotomy. We reviewed all patients that underwent an ERCP with native papilla from 2006 to 2014 at two tertiary institutions. Efficacy was based on the cannulation rate of the second ERCP, and safety was assessed in terms of adverse events. We identified 112 patients with failed cannulation after precut, and a second ERCP was performed in 72 (64.3%). Median time between procedures was 7 days (IQR 5-11). Deep cannulation was achieved in 54 cases (75%). The only factor associated with cannulation failure was an ERCP within 4 days after the initial precut (cannulation success 44.4 vs. 79.4% after 4 days, p = 0.026). Adverse events were recorded after the first ERCP in 13 of 112 patients (11.8%): delayed bleeding in four, pancreatitis in five, and perforation in four. After the second ERCP, three of 72 patients (4.2%) presented adverse events: two delayed bleeding and one pancreatitis. A second ERCP after failure of initial biliary cannulation following precut appears to be safe and effective. A second ERCP should be delayed at least 4 days if feasible.

The most reliable indicators for post-ERCP acute pancreatitis are elevated amylase levels and abdominal pain 24 hours after ERCP. As ERCP is often performed on an outpatient basis, earlier diagnosis is important. We aimed to identify early predictors of post-ERCP pancreatitis. We prospectively analyzed IL-6, IL-10, TNFα, CRP, amylase and lipase before and 4 hours after ERCP, and studied their association with abdominal pain. We included 510 patients. Post-ERCP pancreatitis occurred in 36 patients (7.1%). IL-6, IL-10, TNFα and CRP were not associated with post-ERCP pancreatitis. Levels of amylase and lipase were higher in patients with pancreatitis (522 U/L and 1808 U/L vs. 78 U/L and 61 U/L, respectively; p 3 ULN. Amylase and lipase were the only markers of post-ERCP pancreatitis 4 hours after the procedure.

Background Flat and sessile lesions are being identified more frequently because of increased awareness, improved endoscopic skills, and enhanced imaging. The defiant polyp (DP) is a lesion identified at colonoscopy that defies resection by the standard snare polypectomy technique. Increasingly, the DP undergoes photodocumentation and tissue sampling, and the patient is referred for an attempt at curative colonoscopic resection. Objective To evaluate the current nature of the DPs and outcomes of their endoscopic resection. Design Retrospective study. Setting Tertiary referral center. Patients and Interventions Patients with colorectal polyps not amenable to standard snare polypectomy were referred to a single endoscopist at a tertiary center for an attempt at curative endoscopic resection. The indication DP was applied prospectively, as defined previously, beginning in June 2007. An electronic endoscopy report database was searched for this indication from June 2007 to October 2009 for a single endoscopist at an endoscopy referral center. Data pertaining to patient age and sex, polyp site and histopathology, resection technique, use of adjunctive ablation, adverse events, and residual/recurrent neoplasia at follow-up were culled. Submucosal injection of varying quantities of normal saline solution tinted with methylene blue dye was used for endoscopic resection. Standard and mini-snares were used with pure coagulation current. Main Outcome Measurements Complete resection, complications, recurrence. Results This study included 274 patients (50.4% women, age 65 [standard deviation 12] years) with a total of 315 DPs who were referred for attempted endoscopic resection. The majority of DPs were located in the right side of the colon (226; 72%). The mean size was estimated at 23 mm (range 8-100 mm; standard deviation 13). In 29 DPs (10%), surgery was required because endoscopic resection was deemed unsuitable because of the unfavorable appearance (n = 3), the location (n = 9), or the inability to lift (n = 10) or because of submucosal invasion on post-EMR histopathology (n = 7). Complete endoscopic eradication (R0) was achieved in a single session in 286 DPs (91%). En bloc resection was performed in 153 polyps (53.5%) and piecemeal resection in 132 (46%). Histopathology revealed 178 tubular adenomas (56.5%), 62 serrated adenomas (20%), 27 tubulovillous adenomas (9%), 10 hyperplastic polyps (3%), and 14 adenocarcinomas (4.5%). Adjunctive ablation of focal residual neoplastic tissue was applied in 69 DPs (24%) to achieve R0. Procedure-related adverse events were recorded in 29 of 249 patients (11.6%). Acute bleeding occurred in 9 patients (1 required hospitalization and repeat endoscopy). There was 1 microperforation managed with clip closure and antibiotics. Delayed bleeding (1-6 days post-procedure) was observed in 18 patients (7.2%), of whom 8 required hospitalization and 4 colonoscopy for hemostasis. Among the patients who underwent follow-up surveillance colonoscopy (135 of 258 patients), residual/recurrent neoplastic tissue at the site of the previous EMR was identified in 36 (27%). Residual/recurrent neoplasia was successfully eradicated with further endoscopic resection or ablation. Limitations A retrospective design. Conclusions DPs consist predominantly of sessile and flat adenomas including serrated adenomas. Most DPs can be successfully eradicated at dedicated therapeutic colonoscopy by using adjunctive resection and ablation techniques. The R0 rate is high and the adverse event rate is low. A relatively high rate of local residual/recurrent neoplasia at the resection site underscores the importance of follow-up colonoscopy.

The aim of this study was to evaluate the restoration of gastrointestinal motility after NOTES using capsule endoscopy (CE).Twenty adult Yorkshire pigs were randomly assigned to four groups: transgastric NOTES (gNOTES), transrectal NOTES (rNOTES), transvaginal NOTES (vNOTES), and laparoscopy (LAP). At the end of a 30-min peritoneoscopy with identification of seven predetermined organs, an array of eight receivers and the recorder were attached to the abdominal wall. The CE was delivered into the antrum with the help of an endoscope and a polypectomy snare. Animals were kept alive for 14 d.Median time for surgery was longer in gNOTES (56 min, range 47-63) and vNOTES (54 min, range 44-79) than in LAP (32 min, range 32-33; P0.05 and P0.01) and in rNOTES (45.5 min, range 33-56) (P = ns). This increase was related to a larger incision and longer closure times. Images from the CE were successfully retrieved in 19 cases. The CE was retained in the stomach in all animals in gNOTES (459 min; range 360-600), but only in one animal in rNOTES and vNOTES and in none in the LAP group. Failure of passage of the CE beyond the stomach was associated with gNOTES and longer closure of the incision. Animals in the gNOTES group gained less weight than the others and this change was statistical significant when compared with vNOTES animals (1.7 kg, range -1.98 to 4.5 versus 8.4 kg, range 5.8 to 11.45; P0.01).Gastric emptying is delayed after gNOTES peritoneoscopy compared with rNOTES, vNOTES, and LAP and this effect is associated with less weight gain.

Inflammatory changes of different NOTES approaches remain unknown. The aim of this study was to compare the inflammatory effects of NOTES and laparoscopy.Forty female pigs were assigned to transgastric, transrectal, and transvaginal NOTES and laparoscopic peritoneoscopy groups. Antiseptic technique was utilized for NOTES whereas laparoscopy was performed sterile. Intraperitoneal pressures were monitored and maintained below 15 mmH(2)O. Pneumoperitoneum was maintained with CO(2) in all groups. Pre- and postoperative blood samples of IL-6, Il-1β, and TNFα, and peritoneal fluid collected at surgery were analyzed. Animals were followed daily for 14 days. At necropsy, peritoneal fluid was collected for cytokine analysis.Thirty-nine peritoneoscopies were successfully completed. The median procedure time was longer in the NOTES groups (57 min, range = 33-109) than in the laparoscopy group (33 min, range 32-36; P0.001); this was related to longer incision time and closure time. All 39 completed follow-up. Severe bleeding in the post-transrectal approach required early sacrifice of the remaining animal. Besides this, complications were similar among groups. At necropsy, adhesions were seen in four animals in the gastric group, five in the rectal group, two in the vaginal group, and two in the laparoscopic group (P = ns). There were no statistical differences in serum levels of TNFα among the groups. When serum TNFα values were expressed as the difference from the baseline, in the transvaginal group they were significantly lower than in the transrectal at 2 h [0.5 pg/ml (range = -14 to 59) vs. 60 pg/ml (range = -8 to 303); P = 0.041] and at 8 h [-5.5 pg/ml (range = -86 to 55] vs. 37 pg/ml (range = -30 to 62); P = 0.031]. The limitations of this study were that the analyses of IL-6 and Il-1β were not possible because most of the samples were below detectable levels, it was an animal model, and the sample size was small.Inflammatory parameters are similar between NOTES and laparoscopic peritoneoscopy despite longer surgery time in the NOTES group. The vaginal route seems to reduce the inflammatory stress.

Aliment Pharmacol Ther 31, 1192–1199 Summary Background Toll-like receptor (TLR) 4 genetic polymorphisms, mainly D299G, have been associated with increased predisposition to infection in several populations. Aim To retrospectively analyse the relationship between the presence of the TLR4 D299G polymorphism and the incidence of bacterial infections in cirrhotic patients. Methods We included 111 consecutive cirrhotic patients hospitalized with ascites and we determined the presence of the TLR4 D299G polymorphism by PCR–RFLP (polymerase chain reaction–restriction fragment length polymorphism) and its relationship with the incidence of previous bacterial infections. Results Ten out of 111 (9%) cirrhotic patients presented with the TLR4 D299G polymorphism. The mean follow-up from first decompensation of cirrhosis until current admission was longer in D299G polymorphism patients than in wild-type patients (53.8 ± 40.7 vs. 35.4 ± 48.3 months, P = 0.03). D299G polymorphism patients showed a trend towards a higher incidence of history of previous infections (80% vs. 56.4%, P = 0.19), as well as a higher number of infections (2.8 ± 2.3 vs. 1.0 ± 1.3, P = 0.01) and bacteriaemias (0.4 ± 1.0 vs. 0.04 ± 0.2, P = 0.02) per patient than wild-type patients. Conclusions Toll-like receptor 4 D299G polymorphism could influence not only the predisposition to bacterial infections but also the evolution of the disease in cirrhotic patients. Further prospective studies in larger series of patients are warranted.

Background: Numerous dietary restrictions and endoscopies limit the implementation of empiric elimination diets in patients with eosinophilic esophagitis (EoE). Milk and wheat/gluten are the most common food triggers. Objective: We sought to assess the effectiveness of a step-up dietary strategy for EoE. Methods: We performed a prospective study conducted in 14 centers. Patients underwent a 6-week 2-food-group elimination diet (TFGED; milk and gluten-containing cereals). Remission was defined by symptom improvement and less than 15 eosinophils/high-power field. Nonresponders were gradually offered a 4-food-group elimination diet (FFGED; TFGED plus egg and legumes) and a 6-food-group elimination diet (SFGED; FFGED plus nuts and fish/seafood). In responders eliminated food groups were reintroduced individually, followed by endoscopy. Results: One hundred thirty patients (25 pediatric patients) were enrolled, with 97 completing all phases of the study. ATFGED achieved EoE remission in 56 (43%) patients, with no differences between ages. Food triggers in TFGED responders were milk (52%), gluten-containing grains (16%), and both (28%). EoE induced only by milk was present in 18% and 33% of adults and children, respectively. Remission rates with FFGEDs and SFGEDs were 60% and 79%, with increasing food triggers, especially after an SFGED. Overall, 55 (91.6%) of 60 of the TFGED/FFGED responders had 1 or 2 food triggers. Compared with the initial SFGED, a step-up strategy reduced endoscopic procedures and diagnostic process time by 20%. Conclusions: A TFGED diet achieves EoE remission in 43% of children and adults. A step-up approach results in early identification of a majority of responders to an empiric diet with few food triggers, avoiding unnecessary dietary restrictions, saving endoscopies, and shortening the diagnostic process.

Background: Endoluminal therapy is an option for selected patients with Barrett's esophagus and high-grade dysplasia or early cancer. Objective: To assess long-term outcomes of patients treated with endoluminal therapy with the goal of complete eradication of all dysplasia and intestinal metaplasia. Design: Retrospective cohort study. Patients: Selected patients referred with dysplastic Barrett's esophagus. Intervention: Endoluminal therapy combining resection and photodynamic therapy, radiofrequency ablation, and/or argon plasma coagulation treatment was individualized based on patient and lesion characteristics, technique evolution, and interval response. Main Outcome Measurements: We assessed complete eradication of dysplasia, all intestinal metaplasia, and recurrences. Results: A total of 166 patients were treated and had at least 1 year of follow-up. Complete elimination of neoplasia was achieved in 157 patients (95%) and complete elimination of intestinal metaplasia in 137 patients (83%). After therapy, patients were followed for 33 (range 18-58) months. Among patients who achieved complete elimination of intestinal metaplasia, subsequent recurrent intestinal metaplasia was detected in 48 (35%) and dysplasia in 12 (9%). Among those who achieved only complete elimination of dysplasia, recurrent dysplasia was detected in 6 of 19 patients (32%). Multifocal dysplasia and patient's age were dysplasia and/ or carcinoma recurrence risk factors in the multivariable and univariable analyses. Complete elimination of intestinal metaplasia was a protective factor in the univariable analysis. Retreatment achieved remission in 90% of cases. Forty-two patients (23.9%) had complications, including 21 with stricture (11.9%) and 1 treatment-related death. Limitations: Retrospective study and evolution of endoscopic modalities. Conclusion: Multiple-mode endoluminal therapy for Barrett's esophagus with high-grade dysplasia or early cancer with intention to complete eradication of all intestinal metaplasia was successful, with low observed recurrence of dysplasia or cancer. However, recurrence of intestinal metaplasia occurs in one-third of cases and supports continued endoscopic surveillance even after complete eradication. (Gastrointest Endosc 2013; 77: 190-9.)

BACKGROUND The hemoglobin threshold for transfusion of red cells in patients with acute gastrointestinal bleeding is controversial. We compared the efficacy and safety of a restrictive transfusion strategy with those of a liberal transfusion strategy. METHODS We enrolled 921 patients with severe acute upper gastrointestinal bleeding and randomly assigned 461 of them to a restrictive strategy (transfusion when the hemoglobin level fell below 7 g per deciliter) and 460 to a liberal strategy (transfusion when the hemoglobin fell below 9 g per deciliter). Randomization was stratified according to the presence or absence of liver cirrhosis. RESULTS A total of 225 patients assigned to the restrictive strategy (51%), as compared with 65 assigned to the liberal strategy (15%), did not receive transfusions (P

Marginal ulceration is a common complication following Roux-en-Y gastric bypass surgery. These ulcers usually occur at the gastrojejunal anastomosis and can cause significant morbidity, resulting in multiple readmissions. The incidence seems to vary widely depending on the surgical technique, and theories about marginal ulcer etiology are abundant, including excess acid, fistula formation, ischemia, bile reflux, foreign body reactions, inflammation, and H. pylori infection. Long-term medical treatment with sucralfate suspension and acid inhibitors seems to heal ulcers in most patients. Additionally, revision surgery has been performed for recalcitrant ulcer disease with variable success.

Early cancer (high-grade dysplasia [HGD] and intramucosal carcinoma [ImCa]) associated with Barrett's esophagus (BE) may have a circumferential spatial predilection.To describe the esophageal circumferential location of early cancer in BE.Retrospective study, single tertiary referral center.One hundred nineteen patients were referred for endoscopic eradication therapy for early cancer associated with BE. Endoscopic images and reports and pathology were reviewed.Circumferential location designation of early cancer in BE by using a clock-face orientation.One hundred nineteen of 131 patients referred for endoscopic eradication therapy had a location designation for their advanced histology (91.9%). There were a total of 57 patients (47.9%) with HGD and 62 patients (52.1%) with ImCa. There was a significantly higher rate of early cancer (HGD or ImCa) in the right hemisphere (12 to 6 o'clock location) compared with the left hemisphere (84.9% vs 15.1%, P.0001). The highest percentage of early cancer was found in the 12 to 3 o'clock quadrant (64.7%); 71.9% of HGD and 58.1% of ImCa lesions were located in the 12 to 3 o'clock quadrant.Retrospective design, single center.Early cancer associated with BE is far more commonly found in the right hemisphere of the esophagus (12 to 6 o'clock) with the highest rate in the 12 to 3 o'clock quadrant. These findings support enhanced scrutiny of the right hemisphere of the esophagus during surveillance and endoscopic treatment of patients with BE.

Intravenous administration of albumin decreases the incidence of renal failure and mortality among patients with spontaneous bacterial peritonitis (SBP). However, it is unclear whether it should be given to all patients with SBP; we evaluated its efficacy.We analyzed data from all episodes of SBP (n = 216) during a 7-year period that occurred in a nonselected series of 167 patients with cirrhosis. Low-risk episodes (urea11 mmol/L and bilirubin68 μmol/L) were not treated with albumin, whereas high-risk episodes (urea11 mmol/L and/or bilirubin68 μmol/L) were or were not given albumin at the discretion of the attending physician.Sixty-four episodes of SBP (29.6%) were low risk and not treated with albumin, whereas 152 (70.4%) were high risk; 73 of these (48%) were treated with albumin and 79 (52%) were not. Renal failure before SBP resolution was less frequent after low-risk episodes than high-risk episodes (4.7% versus 25.6%; P = .001), in-hospital mortality was lower (3.1% versus 38.2%; P.001), and the 3-month probability of survival was higher (93% versus 53%; P.001). In an analysis of only the high-risk group, patients who received albumin had lower in-hospital mortality than those not treated with albumin (28.8% versus 46.8%; P = .02) and a greater 3-month probability of survival (62% versus 45%; P = .01).Albumin therapy increases survival of patients who have high-risk episodes of SBP, although it does not seem to be necessary for patients with low risk of death.

BACKGROUND: Infection in natural orifice transluminal endoscopic surgery (NOTES) remains controversial. OBJECTIVE: To estimate the frequency of infection during NOTES peritoneoscopy with different routes of access and to compare with laparoscopy. DESIGN: Prospective randomized controlled study (Canadian Classification type I). METHODS: Forty female pigs were randomly assigned to 3 NOTES (transgastric, transrectal, and transvaginal) and laparoscopic groups. Antiseptic technique was used for NOTES, whereas laparoscopy was performed in a sterile environment. Preoperative and postoperative intravenous antibiotics were administered. Closure of the transluminal access site was performed in all animals. Peritoneal fluid was collected for culture at the end of surgery and at necropsy at day 14. RESULTS: Thirty-nine peritoneoscopies were successfully completed. Necropsy confirmed complete healing of NOTES incisions, but 2 animals in the laparoscopy group had small abscesses in the abdominal incisions. There were no statistical differences in the presence of peritoneal adhesions. Positive culture results were seen in all groups at the end of the procedure and in all animals at necropsy, but this did not lead to clinical signs of gross infection. The most common organisms that colonized the peritoneum were gram-positive cocci and gram-negative bacilli from the normal swine gastrointestinal flora. LIMITATIONS: Animal model and small sample size. CONCLUSIONS: In these small series of animals and with the careful lavage and preparation used, NOTES appeared to be comparable to laparoscopy in terms of peritoneal contamination and clinical infection. Despite the adherence to a strict antiseptic protocol, peritoneal contamination occurs but does not lead to septic complications in the swine.

To evaluate the feasibility, reproducibility and efficacy of a new tissue anchoring device in a porcine survival model.Gastrotomies were performed using a needle-knife and balloon dilator in 10 female Yorkshire pigs weighing 30-35 kg. Gastric closure was attempted using a new tissue anchoring device. The tightness of the closure was confirmed by means of air insufflation and the ability to maintain gastric distension with stability in peritoneal pressure measured with a Veress needle. All animals were monitored daily for signs of peritonitis and sepsis over 14 d. During necropsy, the peritoneal cavity and the gastric access site were examined.Transgastric access, closure and 14 d survival was achieved in all pigs. The mean closure time was 18.1 ± 19.2 min and a mean of 2.1 ± 1 devices were used. Supplementary clips were necessary in 2 cases. The closure time was progressively reduced (24.8 ± 13.9 min in the first 5 pigs vs 11.4 ± 5.9 min in the last 5, P = NS). At necropsy, the gastric access site was correctly closed in all cases with all brace-bars present. One device was misplaced in the mesocolon. Minimal adhesions were observed in 3 pigs and signs of mild peritonitis and adhesions in one.The use of this new tissue anchoring device in porcine stomachs is feasible, reproducible and effective and requires a short learning curve.

Background: Pancreatic cystic lesions present a challenge for patients and physicians alike. Morphology alone is inaccurate in discriminating lesion pathology, and use of EUS-guided FNA (EUS-FNA) improves accuracy. Current American Society for Gastrointestinal Endoscopy guidelines recommend prophylactic antibiotics during FNA of cystic lesions to minimize infection risk. However, evidence pertaining to infection risk has been conflicting. The use of prophylactic antibiotics might not be free of other adverse events and might not prevent infection. Objective: To assess the impact of antimicrobial therapy for prophylaxis during EUS-FNA of pancreatic cysts. Design: Retrospective cohort study. Patients: This study involved all patients who underwent EDS-FNA of pancreatic cysts at one institution from May 2007 to April 2010. Intervention: Antibiotic prophylaxis for EUS-FNA. Main Outcome Measurements: Infection of a pancreatic cyst, fever, or bacteremia after EUS-FNA. Secondary variables included other complications of the procedure related to the use of prophylaxis (ie, allergic reactions, secondary infections). Results: EUS-FNA was performed on 253 patients in 266 procedures. Antibiotics were used in 88 endoscopy cases (ATB group), whereas no antibiotics were used in 178 cases (NATB group). There were no differences in patient or cyst characteristics between groups. There were 4 major complications in the NATB group (localized bleeding, 2; pancreatitis, 1; bile leakage, 1) and 2 in the ATB group (possible cyst infection, 1; bile leakage, 1) (P = 1.0). Eight mild adverse events were observed in the NATB group and 6 in the ATB group (P = .56). Infections and antibiotic-related complications occurred in 1 (0.6%) (transient fever) in the NATB group and 4 (4.5%) in the ATB group (local allergic reaction, 2; possible cyst infection, 1; Clostridium difficile diarrhea, 1) (P = .04). Limitations: Retrospective analysis. Conclusion: The incidence of infectious complications after EUS-FNA of pancreatic cystic lesions, with or without antibiotic prophylaxis, appears very low. We have not observed a protective effect from periprocedural prophylactic antibiotic administration. (Gastrointest Endosc 2011;74:81-6.)

D F c C p Endoscopic management of refractory benign esophageal strictures can be challenging, requiring multiple endoscopic procedures for successful remediation. Retrievable, self-expandable plastic stents (SEPS) have been U.S. Food and Drug Administration approved for this indication. We present an unanticipated complication that occurred after placement and removal of a SEPS, with development of a fistula to an anterior cervical plate, its recognition, management, and resolution.

Endoscopic biliary stenting is a well-established palliative treatment in patients with unresectable malignant biliary strictures. Obstruction of uncovered self-expanding metal stent (SEMS) due to tumor ingrowth is the most frequent complication. Partially covered SEMS might increase stent patency but could favor complications related to stent covering, such as pancreatitis, cholecystitis, and migration. The aim of this study was to evaluate the efficacy and safety of partially covered SEMS in patients with an unresectable malignant biliary stricture. Patients with malignant extrahepatic biliary obstruction treated endoscopically with partially covered SEMS were included in this multicenter, prospective, nonrandomized study. One hundred ninety-nine patients were endoscopically treated with partially covered SEMS in 32 Spanish hospitals. Clinical success after deep cannulation was 96%. Early complications occurred in 4% (3 pancreatitis, 2 cholangitis, 1 hemorrhage, 1 perforation, and 1 cholecystitis). Late complications occurred in 19.5% (18 obstructions, 10 migrations, 6 cholangitis without obstruction, 3 acute cholecystitis, and 2 pancreatitis), with no tumor ingrowth in any case. Median stent patency was 138.9 ± 112.6 days. One-year actuarial probability of stent patency was 70% and that of nonmigration was 86%. Multivariate analysis showed adjuvant radio- or chemotherapy as the only independent predictive factor of stent patency and previous insertion of a biliary stent was the only predictive factor of migration. The partially covered SEMS was easily inserted, had a high clinical success rate, and prevented tumor ingrowth. The incidence of possible complications related to stent coverage, namely, migration, pancreatitis, and cholecystitis, was lower than in previously published series.

Background and study aims Most natural orifice transluminal endoscopic surgery (NOTES) procedures have been performed in animal models through the anterior stomach wall, but this approach does not provide efficient access to all anatomic areas of interest. Moreover, injury of the adjacent structures has been reported when using a blind access. The aim of the current study was to assess the utility of a CT-based (CT: computed tomography) image registered navigation system in identifying safe gastrointestinal access sites for NOTES and identifying intraperitoneal structures. Methods A total of 30 access procedures were performed in 30 pigs: anterior gastric wall (n = 10), posterior gastric wall (n = 10), and anterior rectal wall (n = 10). Of these, 15 procedures used image registered guidance (IR-NOTES) and 15 procedures used a blind access (NOTES only). Timed abdominal exploration was performed with identification of 11 organs. The location of the endoscopic tip was tracked using an electromagnetic tracking system and was recorded for each case. Necropsy was performed immediately after the procedure. The primary outcome was the rate of complications; secondary outcome variables were number of organs identified and kinematic measurements. Results A total of 30 animals weighting a mean (± SD) of 30.2 ± 6.8 kg were included in the study. The incision point was correctly placed in 11 out of 15 animals in each group (73.3 %). The mean peritoneoscopy time and the number of properly identified organs were equivalent in the two groups. There were eight minor complications (26.7 %), two (13.3 %) in the IR-NOTES group and six (40.0 %) in the NOTES only group ( P = n. s.). Characteristics of the endoscope tip path showed a statistically significant improvement in trajectory smoothness of motion for all organs in the IR-NOTES group. Conclusion The image registered system appears to be feasible in NOTES procedures and results from this study suggest that image registered guidance might be useful for supporting navigation with an increased smoothness of motion.