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Background and Aims: Esophageal stricture (ES) is a severe adverse event following wide-field endoscopic submucosal dissection (ESD) of superficial esophageal carcinoma. This study evaluated the efficacy and safety of combining endoscopic vacuum therapy (EVT) and budesonide orodispersible tablet (BOT) in preventing post-ESD strictures., Methods: This prospective case series included patients with superficial esophageal squamous cell carcinoma and adenocarcinoma who had wide-field ESD (≥75% circumference, resection length ≥50 mm). After ESD, EVT was applied immediately, followed by 8 weeks of BOT. The main outcome measurement was the incidence of post-ESD stricture., Results: Eleven patients underwent ESD. Of these, 81.8% had 75-99% circumference resected, and 18.2% had a circumferential resection. EVT remained in situ for a mean of 3.5 days. No esophageal strictures were observed by the final follow-up. There were no major adverse events related to EVT or BOT., Conclusions: The prophylactic combination of EVT and BOT is a novel and promising strategy for reducing post-ESD strictures., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Today, endoscopy plays a decisive role not only in the detection of colorectal adenomas and carcinomas, but also in the treatment of precancerous lesions, in particular flat adenomas and early carcinomas. In recent years, endoscopic submucosal dissection (ESD) has become increasingly important alongside classic polypectomy and mucosal resection after saline injection using a snare (EMR). Using ESD the lesion is marked, injected submucosally using viscous substances and the mucosa incised and tunneled with a transparent cap and a fine diathermy knife. Particularly in the case of widespread and high-risk lesions ESD enables a quasi-surgical "en bloc" resection almost regardless of size, with a histological R0 resection rate of far over 90% in specialized centers. ESD enables an excellent histopathological evaluation and has a low recurrence risk of 1-3%. Endoscopic full-thickness resection using a dedicated device (FTRD system) represents another addition to the armamentarium. It can be used for circumscribed submucosal, suspicious or scarred changes up to 2 cm in the middle and upper rectum. Endoscopic intermuscular dissection (EID) enables histopathological analysis of the complete submucosa beyond the mucosa and upper submucosal layer by including the circular inner muscle layer within the resection specimen. It reduces basal R1 situations and offers a new perspective for T1 carcinomas through curative, organ-preserving endoscopic therapy, especially in the case of deep submucosal infiltration alone, without other risk factors for metastases. Indications, the procedure itself and significance of the various techniques for premalignant and early malignant lesions in the rectum are presented., Competing Interests: Es besteht kein primärer Interessenskonflikt in Bezug auf den Beitrag. Forschungsunterstützung: Erbe, Tübingen: Fujifilm Europe, Ratingen; Medtronic, Meerbusch; Ovesco, Tübingen. Honorare für Vorträge: Falk Foundation, Freiburg; Fujifilm Europe, Ratingen; Ovesco, Tübingen., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Objectives: Endoscopic trans-anal colonic decompression (ECD) may be requested in the case of massive colon distension, but evidence regarding success and safety issues remains scarce. The aim of this analysis is to examine the technical success, complications and clinical outcome in a large series of patients undergoing an ECD in various clinical scenarios. A standardized evaluation system was used to identify the pre-interventional risk parameters that might be helpful to guide clinical decision making., Methods: In this single-centre retrospective study, the modified Clavien-Dindo classification (CDC) was applied to assess technical success, complications and clinical outcome of 125 consecutive patients who underwent ECD between 2007 and 2020., Primary Endpoint: post interventional 90-day mortality. Secondary endpoints: periprocedural complications (CDC event IV-V) and technical success rate. All Martin criteria for standardized reporting of complications were met. Uni- and multivariable analyses for prediction of complications were carried out., Results: The overall technical success rate was 90%. The periprocedural complication rate was low with 3%. Overall 90-day mortality was 31%. Univariable analyses showed a significant correlation between 90-day mortality and ASA≥4 (p<0.001, odds ratio [OR] 15.33), general anaesthesia (p=0.05, OR 21.42) and elevated serological infection parameters (p 0.028, OR 1.004). The pre-interventional multivariable model identified ASA ≥4 (p <0.001; OR 10.94) as the only independent risk factor., Conclusions: ECD is a safe, easily available, technical feasible, inexpensive and successful tool for colonic decompression in various colonic obstruction scenarios, even in critically ill patients. ASA Score ≥IV can be helpful to identify patients at risk for complications/mortality after ECD., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Delayed bleeding is the most frequent complication after endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) of large colon polyps. Today, prophylactic clipping with through-the-scope clips (TTSCs) is commonly used to reduce the risk of bleeding. However, the over-the-scope clip (OTSC) system might be superior to TTSCs in achieving hemostasis. This study aims to evaluate the efficacy and safety of prophylactic clipping using the OTSC system after ESD or EMR of large colon polyps., Methods: This is a retrospective analysis of a prospective collected database from 2009 until 2021 of three endoscopic centers. Patients with large (≥ 20 mm) colon polyps were enrolled. All polyps were removed by either ESD or EMR. After the resection, OTSCs were prophylactically applied on parts of the mucosal defect with a high risk of delayed bleeding or/and perforation. The main outcome measurement was delayed bleeding., Results: A total of 75 patients underwent ESD (67%, 50/75) or EMR (33%, 25/75) in the colorectum. The mean resected specimen diameter was 57 mm ± 24.1 (range 22-98 mm). The mean number of OTSCs placed on the mucosal defect was 2 (range 1-5). None of the mucosal defects were completely closed. Intraprocedural bleeding occurred in 5.3% (ESD 2.0% vs. EMR 12.0%; P = 0.105), and intraprocedural perforation occurred in 6.7% (ESD 8% vs. EMR 4%; P = 0.659) of the patients. Hemostasis was achieved in 100% of cases of intraprocedural bleeding, whereas two patients required surgical conversion due to intraprocedural perforation. Among the remaining 73 patients who received prosphylactic clipping, delayed bleeding occurred in 1.4% (ESD 0% vs. EMR 4.2%; P = 0.329), and delayed perforation occurred in 0%., Conclusions: The prophylactic partial closure of large post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation. The prophylactic partial closure of large complex post-ESD/EMR mucosal defects using OTSCs could serve as an effective strategy to reduce the risk of delayed bleeding and perforation., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aims: Over-the-scope clips (OTSCs) substantially improved the endoscopic armamentarium for the treatment of severe GI bleeding and can potentially overcome limitations of standard clips. Data indicate a superiority of OTSCs in hemostasis as first- and second-line therapy. However, the impact of the OTSC designs, in particular the traumatic (-t) or atraumatic (-a) type, in duodenal ulcer bleeding has not been analyzed so far., Methods: This was a retrospective analysis of a prospective collected database from 2009 to 2020 of 6 German endoscopic centers. All patients who underwent emergency endoscopy and were treated using an OTSC for duodenal ulcer bleeding were included. OTSC-t and OTSC-a patients were compared by the Fisher exact test, χ 2 test, or Mann-Whitney U test as appropriate. A propensity score-based 1:1 matching was performed to obtain equal distribution of baseline characteristics in both groups., Results: The entire cohort comprised 173 patients (93 OTSC-a, 80 OTSC-t). Age, gender, anticoagulant therapy, Rockall score, and treatment regimen had similar distributions in the 2 groups. However, the OTSC-t group showed significantly more active bleeding ulcers (Forrest Ia/b). Matching identified 132 patients (66 in both groups) with comparable baseline characteristics. Initial bleeding hemostasis (OTSC-a, 90.9%; OTSC-t, 87.9%; P = .82) and 72-hour mortality (OTSC-a, 4.5%; OTSC-t, 6.0%; P > .99) were not significantly different, but the OTSC-t group revealed a clearly higher rate of recurrent bleeding (34.9% vs 7.6%, P < .001) and necessity of red blood cell transfusions (5.1 ± 3.4 vs 2.5 ± 2.4 concentrates, P < .001)., Conclusions: For OTSC use, the OTSC-a should be the preferred option for duodenal ulcer bleeding., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Introduction: Risk stratification in upper gastrointestinal bleeding (UGIB) currently relies on clinical parameters and risk scores. HemoPill ® acute (Ovesco Endoscopy, Tuebingen, Germany) is a pill-shaped, orally administered sensor capsule for real-time blood detection. The aim of this study was to evaluate the system in clinical routine., Material and Methods: Sixty-one consecutive patients in whom the HemoPill ® had been used at 12 international hospitals between July 2019 and March 2020 were retrospectively analysed. Indications for application were the clinical suspicion of UGIB, small bowel bleeding, of rebleeding after hemostasis. Primary endpoints were technical success and bleeding detection/exclusion. Secondary endpoints included adverse events and change of clinical course., Results: The capsule was used in 45 (73%) patients with UGIB, in 12 (20%) patients with small bowel bleeding and in four (7%) patients for exclusion of rebleeding. Technical success was 98%. 35/60 (58%) cases were capsule-positive and among these, endoscopy showed bleeding in 20/35 (57%) cases. None of the 25 capsule-negative patients rebled. Emergency endoscopy could be avoided in 18/25 (72%) cases. Serious adverse events did not occur., Conclusion: HemoPill ® -based blood detection is feasible and safe. Negative capsule results might 'downgrade' the need for urgent endoscopy.

Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H - mean 93.0% [95%CI 90.2-95.4], AL-mean 89.7% [95%CI 85.9-92.9] and CL-mean 83.8% [95%CI 76.9-89.7]. Pooled durable clinical success proportions were: H-mean 87.5% [95%CI 80.5-93.2], AL-mean 81.4% [95%CI 77.0-85.3] and CL-mean 63.0% [95%CI 53.0-72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.

Introduction: Endoscopic resection techniques can successfully resect large lesions either in "en bloc" fashion or in "piece-meal" technique by using a submucosal injection solution. The aim of this study was to evaluate the safety of a novel injectable, containing thermally sensitive co-polymer from ethylenoxide and propylenoxide (LiftUp) used as submucosal injection solution. Material and methods: We conducted an in vivo animal trial in the porcine model to evaluate the LiftUp gel in a preclinical setting and to study the effectiveness of mucosal lifting and the safety of the new injectable. In seven animals a total of 63 injections and endoscopic resections were carried out in different anatomical locations (esophagus, stomach and rectum). The resection sites were controlled endoscopically one and four weeks after resection and a histopathological evaluation of the resection sites was performed after four weeks. Results: The application of LiftUp was safe and there were no negative effects on wound healing after injection and resection. A major procedural complication rate (defined as perforation and major haemorrhage) of 3.2% was registered, which undercuts the anticipated mean complication rate of 4-8%. Furthermore, there was no necessity of reinjection after the initial submucosal injection in 90.5% and no procedural complications in 98.8%. The histopathological examination of the tissue samples indicated normal wound healing with granulation tissue and epithelialisation. Conclusion: The use of LiftUp as submucosal injection solution was feasible for different endoscopic resection techniques, with high and long-lasting elevation and fewer procedural adverse events than expected at trial planning. The new injectable is a practical advancement over the current state-of-the-art of submucosal injection and could fasten up the resection procedure and make endoscopic 'en bloc' resection safer.

Introduction  Endoscopic submucosal dissection (ESD) is increasingly being used in the western world. Submucosal injectates are an essential tool for the ESD procedure. In this study, we evaluated a novel copolymer injectate (LiftUp, Ovesco, Tübingen Germany) in an established ESD model (EASIE-R) in comparison to existing submucosal injectables. Materials and methods  We conducted a prospective, randomized ex vivo study performing ESD with three injectates: LiftUp, hydroxyethyl starch (HAES 6 %) and normal saline solution (NaCl 0.9 %). A total of 60 artificial lesions, each 3 × 3 cm in size, were resected in an ex vivo porcine model, utilizing one of the three studied injectates (n = 20 ESDs per injectate). Study parameters were: en bloc resection rate, perforation rate, lifting property, time of injection, injectate volume, general ESD procedure time, and overall procedure time. Results  All 60 lesions were successfully resected using the standard ESD technique. LiftUp had no procedure related perforations, one perforation occurred in the HAES group, and two perforations in the NaCl group ( P  > 0.05). Furthermore, adequate lifting was achieved in 16/20 (80 %) using LiftUp, 6/20 (30 %) in the HAES group and 6/20 (30 %) in the NaCl group ( P  < 0.0002). En bloc resection was achieved in 19 (95 %) with LiftUp, in 20 (100 %) with HAES, and in 16 (80 %) with NaCl. General ESD procedure time and overall procedure time were not different among the three groups. Conclusion  LiftUp appears to be a safe alternative to established fluids for ESD. It had a significantly improved lifting effect and required significantly less injected volume compared to well-established lifting solutions.

Introduction: The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB., Patients and Methods: In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29-93 years; mean (±SD) 71.39 ± 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3-10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC ≤3)], moderate risk (RRC 4-7), and high risk (RRC ≥8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher's Exact Test., Results: Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC ≥8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4-7) with 4.9% as well as in the high-risk group (RRC ≥8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001)., Conclusions: This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.

The full-thickness resection device (FTRD) is a novel endoscopic device approved for the resection of colorectal lesions. This case-series describes the device and its use in high-risk patients with colorectal lesions and provides an overview of the potential indications in recently published data. Between December 2014 and September 2015, 3 patients underwent endoscopic full thickness resection using the FTRD for colorectal lesions: 1 case for a T1 adenocarcinoma in the region of a surgical anastomosis after recto-sigmoidectomy, 1 case for a non-lifting colonic adenoma with low-grade dysplasia in an 89-year old patient and 1 for a recurrent adenoma with high-grade dysplasia in a young patient with ulcerative rectocolitis who was under immunosuppression after renal transplantation. Both technical and clinical success rates were achieved in all cases. The size of removed lesions ranged from 9 to 30 mm. Overall, the most frequent indication in the literature has been for lifting or non-lifting adenoma, submucosal tumors, neuroendocrin tumors, incomplete endoscopic resection (R1) or T1 carcinoma. Colorectal FTRD is a feasible technique for the treatment of colorectal lesions and represents a minimally invasive alternative for either surgical or conventional endoscopic resection strategies.

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

A uniform and comprehensive terminology is essential in the correct documentation of diagnostic or therapeutic endoscopic procedure. In the German-speaking world, the standard terminology available so far is based on a previous version published in 1999. Therefore, the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) has undergone a comprehensive revision and re-structuring of the terminology. This appeared mandatory due to various changes, new diagnoses and new endoscopic procedures. The suggestions drawn up by individual working groups were approved by consensus and are now available as an online document (https://doi.org/10.1055/s-0043-121167) for modifying current software systems. In order to ensure an up-to-date documentation in the future, it was decided that annual updates will be performed by the DGVS to check respective software packages for modifications and new contents., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (© Georg Thieme Verlag KG Stuttgart · New York.)

Introduction:  The over-the-scope-clip (OTSC) can potentially overcome limitations of standard clips and achieve more efficient and reliable hemostasis. Data on OTSC use for non-variceal upper gastrointestinal bleeding (NVUGIB) in patients with cardiovascular comorbidities are currently limited., Patients and Methods:  We prospectively collected and retrospectively analyzed our database from February 2009 to September 2015 from all patients who underwent emergency endoscopy for high-risk NVUGIB in 2 academic centers and were treated with OTSC as first-line (n = 81) or second-line therapy (n = 19)., Results:  One hundred patients mean age 72 (range 27 - 97 years) were included in this study. Fifty-one percent (n = 51) had severe cardiovascular co-morbidity (ischemic heart disease, congestive heart failure, hypertension, valvular heart disease, peripheral arterial occlusive disease and atrial fibrillation) and 73 % (n = 73) were on antiplatelet or/and anticoagulation therapy. The median size of the treated ulcers was 3 cm (range 1 - 5 cm). In 94 % (n = 94) primary hemostasis with OTSC was achieved. Clinical long-term success during a mean 6-month follow-up without rebleeding was 86 % (n = 86)., Conclusions:  In this cohort OTSC was demonstrated to be a safe and effective first- or second-line treatment for NVUGIB in high-risk patients with cardiovascular disease and complex, large ulcers.

Background: Percutaneous transhepatic biliary drainage (PTBD) is widely performed as a salvage procedure in patients with unresectable malignant obstruction of the common bile duct (CBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) or in case of surgically altered anatomy. Endoscopic ultrasound-guided hepaticogastrostomy (EU-HGS) is a more recently introduced alternative to relieve malignant obstructive jaundice. The aim of this prospective observational study was to compare the outcome, efficacy and adverse events of EU-HGS and PTBD., Methods: From April 2012 to August 2015, consecutive patients with malignant CBD obstruction who underwent EU-HGS or PTBD in two tertiary-care referral centers were included. The primary endpoint was the clinical success rate. Secondary endpoints were technical success, overall survival, procedure-related adverse events, incidence of adverse events, and reintervention rate., Results: A total of 51 patients (EU-HGS, n = 31; PTBD, n = 20) were included. Median survival was 71 days (range 25-75th percentile; 30-95) for the EU-HGS group and 78 days (range 25-75th percentile; 42-108) for the PTBD group ( p = 0.99). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25 (86%) of 31 patients in the EU-HGS group and in 15 (83%) of 20 patients in the PTBD group ( p = 0.88). There was no difference in adverse events rates between the two groups (EU-HGS: 16%; PTBD: 10%) ( p = 0.69). Four deaths within 1 month (two hemorrhagic and two septic) were considered procedure related (two in the EU-HGS group and two in the PTBD group). Overall reintervention rate was significantly lower after EU-HGS ( n = 2) than after PTBD ( n = 21) ( p = 0.0001). Length of hospital stay was shorter after EU-HGS (8 days versus 15 days; p = 0.002)., Conclusions: EU-HGS can be an effective and safe mini invasive-procedure alternative to PTBD, with similar success and adverse-event rates, but with lower rates of reintervention and length of hospitalization., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest.

Endoscopic submucosal dissection (ESD) is widely practiced in Japan and the Eastern World and is rapidly expanding in western countries for the management of early malignancies of the upper and lower gastrointestinal tube. In addition, novel therapeutic applications deriving from ESD have emerged including the treatment of achalasia, of submucosal tumors, of diverticula, of strictures and of reflux disease. An ESD procedure necessitates not only skills and specific training, but also familiarization with a vast spectrum of devices (endoscopes, high-frequency generators and their settings, endoknives, hoods, irrigation devices) and techniques (such as countertraction, artificial ulcer closure), that render the procedure faster, more efficient and safer. This technological article gives an overview on current and novel equipment for an ESD and associated techniques.

Aim: To investigate the efficacy and clinical outcome of patients treated with an over-the-scope-clip (OTSC) system for severe gastrointestinal hemorrhage, perforations and fistulas., Methods: From 02-2009 to 10-2012, 84 patients were treated with 101 OTSC clips. 41 patients (48.8%) presented with severe upper-gastrointestinal (GI) bleeding, 3 (3.6%) patients with lower-GI bleeding, 7 patients (8.3%) underwent perforation closure, 18 patients (21.4%) had prevention of secondary perforation, 12 patients (14.3%) had control of secondary bleeding after endoscopic mucosal resection or endoscopic submucosal dissection (ESD) and 3 patients (3.6%) had an intervention on a chronic fistula., Results: In 78/84 patients (92.8%), primary treatment with the OTSC was technically successful. Clinical primary success was achieved in 75/84 patients (89.28%). The overall mortality in the study patients was 11/84 (13.1%) and was seen in patients with life-threatening upper GI hemorrhage. There was no mortality in any other treatment group. In detail OTSC application lead to a clinical success in 35/41 (85.36%) patients with upper GI bleeding and in 3/3 patients with lower GI bleeding. Technical success of perforation closure was 100% while clinical success was seen in 4/7 cases (57.14%) due to attendant circumstances unrelated to the OTSC. Technical and clinic success was achieved in 18/18 (100%) patients for the prevention of bleeding or perforation after endoscopic mucosal resection and ESD and in 3/3 cases of fistula closure. Two application-related complications were seen (2%)., Conclusion: This largest single center experience published so far confirms the value of the OTSC for GI emergencies and complications. Further clinical experience will help to identify optimal indications for its targeted and prophylactic use.

Endoscopic submucosal dissection (ESD) was developed in Japan but has now also become permanently established in various centers in Europe. ESD is an endoscopic en bloc mucosal resection technique for the treatment of early cancers with a diameter >1 cm and also superficial precancerous lesions, which could only be removed unsatisfactorily in several fragments or with uncertain lateral safety margins using previous loop excision procedures. Using ESD a lesion is excised after circular marking and generous submucosal injection with a safety margin of approximately 5 mm and subsequently resected at the level of the submucosa with a 1-3 mm short diathermic knife. ESD requires high technical skills in interventional endoscopy and is more time-consuming than snare resection techniques. However, numerous studies have shown a clear superiority for ESD with respect to the R0 resection rate and the local recurrence rate. The present article gives a current review of the use of ESD in the upper and lower gastrointestinal tract and demonstrates perspectives of the procedure.

Background & Aims: Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA., Methods: We performed an international, multidisciplinary, systematic, evidence-based review of different management strategies for patients with BE and dysplasia or early-stage EA. We used a Delphi process to develop consensus statements. The results of literature searches were screened using a unique, interactive, Web-based data-sifting platform; we used 11,904 papers to inform the choice of statements selected. An a priori threshold of 80% agreement was used to establish consensus for each statement., Results: Eighty-one of the 91 statements achieved consensus despite generally low quality of evidence, including 8 clinical statements: (1) specimens from endoscopic resection are better than biopsies for staging lesions, (2) it is important to carefully map the size of the dysplastic areas, (3) patients that receive ablative or surgical therapy require endoscopic follow-up, (4) high-resolution endoscopy is necessary for accurate diagnosis, (5) endoscopic therapy for HGD is preferred to surveillance, (6) endoscopic therapy for HGD is preferred to surgery, (7) the combination of endoscopic resection and radiofrequency ablation is the most effective therapy, and (8) after endoscopic removal of lesions from patients with HGD, all areas of BE should be ablated., Conclusions: We developed a data-sifting platform and used the Delphi process to create evidence-based consensus statements for the management of patients with BE and early-stage EA. This approach identified important clinical features of the diseases and areas for future studies., (Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: The authors hypothesized that by combining transumbilical, transvaginal, and transrectal accesses, complex bowel operations, including proctocolectomy with restorative J pouch [corrected] reconstruction, might be possible., Methods and Results: Out of a series of 30 natural orifice surgery (NOS) operations performed at the authors' institution in the past 12 months, proctocolectomy with ileoanal pouch reconstruction was planned for 3 female patients (31 years, BMI = 30; 50 years, BMI = 31; 30 years, BMI = 21) with extensive disease of ulcerative colitis, and they were operated via a 3-lumenal NOS approach. The first 2 patients received a proctocolectomy with a J-pouch formation. A 3-stage procedure was planned for the third patient, and she received a total colectomy. The colonic specimen was retrieved through the anus obviating dilation of the vagina. The J-pouch was prepared through a horizontal 2-cm incision, which later served as the protective loop ileostomy site., Conclusion: Trilumenal NOS proctocolectomy is feasible and safe providing a solution to overcome the lack of triangulation using a single-lumen approach.

Background: Minimal invasive surgery has led to a significant decrease in surgical trauma, pain, recovery time and improved cosmesis compared with open surgery. However, scar development and the risk of hot spots for infections and hernias are still present. Natural orifice surgery (NOS) promises to offer even further reduction in invasiveness and thus may lead to even faster recovery. The goal of this study was to establish a NOS colonic resection by using commercially available standard surgical instruments avoiding major abdominal incisions., Methods and Results: This article reports a new triluminal hybrid NOS approach for sigmoid and colonic resection (Tri-Port-NOS-SIG), established using rigid laparoscopic instruments through the umbilicus, the vagina, and the rectum, without any major abdominal incision. The specimen was retrieved through the anus avoiding dilatation of the vagina. In an early series of 5 patients the first patient was a 37-year-old woman with a 10-year history of recurrent diverticulitis. She recovered quickly and was discharged on postoperative day 2. She returned to sports activity on day 12 postoperatively and to her heavy-duty job on day 16. The following 4 patients also recovered well and were discharged on postoperative days 7 (2 patients), 8, and 11, respectively. One patient experienced a temporary, mild paresthesia of the left lower dorsal leg, most likely because of intraoperative positioning. No major complications occurred., Conclusion: Tri-Port-NOS-SIG offers a feasible scarless approach for abdominal resections using commercially available surgical instruments in experienced hands.

In the past 10 years endoscopic diagnostics has benefited from technologies such as big chips, high-definition television (HDTV) and narrow band imaging (NBI). Video capsule endoscopy and double balloon enteroscopy have facilitated visualization of the entire small bowel. A number of studies on mucosal Barrett's and gastric cancers could prove that endoscopic mucosal resection (EMR) is oncologically equivalent to surgical resection when certain criteria are respected. However, EMR is less invasive and carries a substantially lower complication risk and mortality compared to surgery. Endoscopic submucosal dissection (ESD) facilitates en bloc resection with thorough histopathologic evaluation of the specimen, e.g. for mucosal lesions in the stomach and rectum. Endosonography (EUS) guided transgastric necrosectomy using a flexible gastroscope has set a milestone in the treatment of infected pancreatic necroses and has replaced open surgery in many centers. Natural orifice transluminal endoscopic surgery (NOTES) uses natural body openings as minimally invasive access to the abdomen and mediastinum. Interventional GI endoscopists and minimally invasive surgeons have profited from these innovations in micromechanics and microelectronics.

There is little information in the literature on endoscopic tumor treatment in the bile duct with a curative intention. This article reports on the few cases published and on the authors' own experience with endoscopic retrograde and percutaneous transhepatic cholangioscopic treatment of tumors in the biliary system.

Background: Since the first presentation of the compactEASIE in 1997, this training model has become established for nearly all interventional techniques in upper gastrointestinal endoscopy including ERCP. So far, training using double-balloon enteroscopy (DBE) for ERCP has not become established., Aims: This paper presents a special organ preparation for the compactEASIE model which for the first time allows simulation of ERCP in patients who have had prior abdominal surgery. Two abdominal organ packages from freshly slaughtered pigs were used to create a postsurgical anatomic situation., Results: A life-like training model was established for ERCP training in a postsurgical anatomic situation. A Roux-en-Y anastomosis was created such that the papilla was located around 100 cm beyond the pylorus. The duodenum was closed shortly above the pig papilla at the level of the pylorus. The papilla was successfully reached by DBE after 40 minutes. The papilla was cannulated and regular contrasting of the biliary system using fluoroscopy was achieved. Sphincterotomy, stent placement and exchange, and needle-knife sphincterotomy over a 7-Fr stent were conducted successfully., Conclusion: Modified organ preparations allow the simulation of and training in ERCP in postsurgical anatomic situations in training models using animal parts.

Background: The objective benefit of a training using the compact Erlangen Active Simulator for Interventional Endoscopy-simulator was demonstrated in two prospective educational trials (New York, France). The present study analysed whether endoscopic novices are able to reach a comparable level of endoscopic skills as in the above-described projects., Methods: Twenty-seven endoscopic novices (medical students, first year residents) were enrolled in this prospective, randomised trial. The compact Erlangen Active Simulator for Interventional Endoscopy-simulator with an upper GI-organ package and blood perfusion system was used as a training tool. Basic evaluation of endoscopic skills was performed after a practical and theoretical course in diagnostic upper GI endoscopy followed by a stratified randomisation according to the rating in endoscopic skills into intensive (n=14) and control group (n=13). The intensive group was trained 12 times every second week over 7 months in 4 endoscopic disciplines (manual skills, injection therapy, haemoclip, band ligation) by skilled endoscopist (three trainees/simulator). Assessment was performed (single steps/overall) using an analogue scale from 1 to 10 (1=worst, 10=optimal performance) by expert tutors. The control group was not trained. Blinded final evaluation of all participants was performed in January 2003., Results: We observed in all techniques applied a significant improvement of endoscopic skills and of the performance time in the intensive group compared to the control group (p<0.001). The comparison with the previous projects showed that the intensively trained novices achieved comparable levels of performance to the GI fellows in the New York and France Project (at least 80% of the median score in three out of four techniques)., Conclusion: Endoscopic novices acquired notable skills in interventional endoscopy in the simulator by an intensive, periodical training using the compactEASIE.

Background: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) using ex-vivo porcine organs was introduced in 1997. The present study should analyze whether repeated EASIE simulator training in endoscopic hemostasis led to superior performance compared with a traditionally educated group. The results were compared with a similar project in New York., Methods: Thirty-five French GI fellows were enrolled. Baseline skills evaluation was performed in four disciplines (manual skills, injection/coagulation, clip application and variceal ligation) using the compactEASIE-simulator equipped with an upper gastrointestinal organ package for bleeding simulation. The same, translated evaluation forms (from the prior New York project) were used. Subsequently, fellows were randomized into group A (n=17, only clinical education) and group B (n=18, additional three simulator trainings). Group B was trained the next day and after 4 and 7 months by experts of the French Society of Gastrointestinal Endoscopy. Both groups performed routine and emergency endoscopies at their home hospitals during the study period. Both groups were re-evaluated blindly after 9 months., Results: The learning curve for group B showed a significant improvement in all disciplines (P<0.004) whereas group A improved significantly in only two of four disciplines at blinded final evaluation (manual skills P=0.02, injection/coagulation P=0.013). The direct comparison of groups B and A at blinded final evaluation showed significantly superior ratings for group B in all disciplines (P<0.006) and significantly shorter performance times in two disciplines (P=0.016 each). The comparison with the similar 'New York project' revealed that preexisting differences in skills were adjusted by the training., Conclusion: Complementary trainings (three workshops in 7 months) in endoscopic hemostasis using the compactEASIE improved skills compared with a solely clinical education. The results of the 'New York project' were confirmed and benefits were independent from the medical educational system.

The introduction of the ex vivo tissue endoscopy simulators represents a major advance in endoscopic training, particularly in therapeutic endoscopy. The simulators have been popular teaching tools from the start, and the data supporting their benefit are accruing, especially in hemostasis training. Simulators like the compact EASIE may prove most beneficial as training tools for interventional skills that require repetitive practice and a larger volume of procedures than may occur naturally during the course of standard endoscopy practice. More data are needed to confirm that hands-on simulator training improves outcomes in clinical endoscopic performance and to characterize better the influence of such simulator work on subsequent endoscopic practice. As ex vivo simulators become more available, it is likely that these models will enhance initial training and also allow practicing gastroenterologists to acquire new techniques, maintain their skills, and demonstrate proficiency for credentialing purposes.

Background and Study Aims: Hemoclip therapy is a well-established procedure in the treatment of gastrointestinal bleeding. Although new products are provided periodically by the industry, comparative investigations are lacking. We compared two different hemoclip devices in an experimental setting, assessing them using objective hemostatic parameters., Materials and Methods: We compared two disposable clip devices (Olympus HX-200L-135 (n = 40) vs. Wilson-Cook Tri-Clip (n = 40)) in an experimental setting using the compact Erlangen Active Simulator for Interventional Endoscopy (compactEASIE) training model equipped with an upper gastrointestinal-organ package for bleeding simulation. This was a randomized, prospective, controlled trial. Four investigators with different levels of endoscopic experience applied ten hemoclip devices of each type to the spurting vessels, the clips allocated using a randomized list for each investigator. The efficacy of hemostasis was determined by continuous measurement of the pressure within the afferent vessel before and after clip application and calculation of the relative reduction of vessel diameter by the clip device. The system pressure was recorded over the period from 1 minute before to 1 minute after clip application. A secondary end point was a subjective assessment of the whole clip application procedure by the endoscopist and the assisting nurse, using a visual analog scale (0 - 100, with 100 representing the best experience)., Results: A total of 39/40 clips of each type were applied successfully. Both clip devices led to a significant increase in system pressure, representing significant relative reduction of vessel diameter (Olympus 5.4 +/- 7.5 %, p < 0.001; Cook 4.9 +/- 8.0 %, p < 0.001). Overall, there was no significant difference between the two devices ( P = 0.756). However, the investigator with the least experience in endoscopy (< 100 procedures) produced significantly inferior results compared with the other three investigators, who had performed between 2000 and 6000 procedures each ( P < 0.05). We found no evidence of a learning curve from the intra-observer results. The devices received good, but not significantly different, overall ratings by the endoscopists (Olympus 69 +/- 24 vs. Wilson-Cook 65 +/- 16) and by the assisting nurses (Olympus 77 +/- 9 vs. Wilson-Cook 70 +/- 22)., Conclusions: Using an established cadaveric training model, no significant difference was found between the two types of hemoclip devices with respect to their "hemostatic efficacy". However, the experience of the endoscopist appears to play a major role in successful clip application. The use of a feedback mechanism in emergency endoscopy training, using continuous intravessel pressure monitoring, may substantially enhance the efficacy of training, resulting in a similar improvement in clinical results.

Background: The efficacy of an intensive hands-on training in endoscopic hemostasis on the compactEASIE simulator has been previously demonstrated in a randomized prospective trial. In the current study, we evaluated how quickly and effectively new tutors, without simulator training experience, are able to acquire teaching skills in endoscopic hemostasis., Methods: Five tutors with prior Erlangen Active Simulator for Interventional Endoscopy (EASIE) teaching experience instructed 7 endoscopists without prior EASIE experience on how to teach when using the model. These new tutors then independently conducted a workshop for 8 fellows in 4 hemostasis techniques. Results were compared with a historical control trained similarly by experienced tutors. Two one-day workshops in endoscopic hemostasis on the compactEASIE ex vivo endoscopy simulator were conducted in a category A hospital in New York City, New York. Skill scores at the end of training were compared with baseline skills assessments, and qualitative ratings of the new tutors were obtained from both the trainees and the experienced tutors., Results: Significant improvement was achieved by the fellows in all 4 skills areas. Both the expert tutors and the trainees consistently rated the teaching skill of the new tutors highly. Fellows' skill acquisition using new tutors was of similar magnitude to that achieved in the prior EASIE trial using experienced trainers teaching the fellows., Conclusions: It is feasible to conduct an effective EASIE train-the-trainer course in one day. Tutors trained in this manner are able to provide a similar educational experience with objective improvement in trainee skill to experts who have conducted many hands-on workshops.

Background and Study Aims: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 as a training model for interventional endoscopy. Objective evidence of the benefits of training with this model has not previously been published. As part of two long-term projects, the benefits of a 1-day training course with the "compactEASIE" simulator were evaluated., Materials and Methods: Fourteen American and 18 French gastroenterology fellows were enrolled. These fellows were participants in the intensive groups performing training in endoscopic hemostasis, with a total number of 28 fellows in New York and 36 in France. Gastrointestinal endoscopy faculty members in New York and France evaluated and timed the fellows in four disciplines to establish baseline skills (manual skills; injection and coagulation; Hemoclip application; and variceal ligation) with the compactEASIE simulator. The trainees were reevaluated after an intensive 1-day course (with two or three fellows and one instructor per station), also including preparation and assistance for each procedure. The assessment (overall and parts) was done by expert tutors using an ordinal scale ranging from 1 to 10 (1 = poorest, 10 = best), recording also mistakes and performance time. The compactEASIE simulator, equipped with an upper gastrointestinal organ package and an artificial blood perfusion system, was used as the training tool., Results: A highly significant improvement ( P < or = 0.001) was observed in the performance of all endoscopic techniques. A significant reduction in performance time was also observed with three of the four endoscopic techniques. Successful hemostasis was significantly improved in two out of three techniques., Conclusions: A 1-day training course on endoscopic hemostasis using the compactEASIE simulator is capable of improving the performance of hemostasis procedures. Long-term effects of repeated training sessions are currently subject of collaborative studies in New York and France.

Background: The need is well recognized for additional data on endoluminal therapies for gastroesophageal reflux disease (GERD). This prospective multicenter clinical trial was designed to assess safety and effectiveness of Enteryx, a nonresorbable copolymer implanted into the lower esophagus, in reducing usage of proton pump inhibitors (PPIs) and improving reflux symptoms and quality of life., Methods: Enteryx implantation was performed under fluoroscopic visualization without general anesthesia in 93 patients with symptomatic GERD responsive to and relapsing upon cessation of PPI therapy. Subjective and objective data were collected up to 12 months postprocedure. The criterion for treatment success was reduction in PPI dosage of > or =50%., Results: At 12 months, treatment success was attained in 86% (confidence interval, 77%-93%) of 74 evaluable patients and elimination of PPI therapy in 65% (confidence interval, 53%-76%). The treatment success rate by intent-to-treat analysis was 69% (confidence interval, 58%-78%). Reflux-related heartburn (P < 0.0001), regurgitation symptoms (P = 0.0005), and physical (P < 0.0001) and mental quality of life (P = 0.0012) scores improved. The most frequent complications were chest pain (77%), dysphagia/odynophagia (27%), and sensation of fever (26%)., Conclusions: Enteryx implantation provides an effective and safe alternative for management of gastroesophageal reflux, reducing medication dependency and symptoms and enhancing quality of life.

Background: The Erlangen Active Simulator for Interventional Endoscopy (EASIE) was introduced in 1997 for interventional endoscopy training. compactEASIE developed in 1998 is a modified, light-weight version of the original model. Objective evidence of the benefits of training with these models is limited. A randomized controlled study, therefore, was conducted to compare the effects of intensive 7-month, hands-on training in hemostatic techniques by using the compactEASIE model (in addition to clinical endoscopic training) vs. pure clinical training in endoscopic hemostatic methods., Methods: Thirty-seven fellows in gastroenterology in New York City area training programs were enrolled. Baseline skills were assessed on the simulator for the following techniques: manual skills, injection and electrocoagulation, hemoclip application, and variceal ligation. Twenty-eight fellows were then randomized into two comparable groups. Those randomized to Group A received purely clinical training in endoscopic hemostatic techniques at their hospitals. Those in Group B, in addition, were trained by experienced tutors in 3 full-day hemostasis workshops over 7 months. Both groups underwent a final evaluation on the compactEASIE simulator conducted by their tutors and additional evaluators who were blinded to the method of training. Initial and final evaluation scores were compared for each group and between groups. Outcomes of actual clinical hemostatic procedures performed during the study period also were analyzed., Results: Ten of 14 fellows randomized to Group A (standard training) and 13 of 14 in Group B (intensive training) returned for the final evaluation. For Group B, scores for all techniques were significantly improved. In Group A, a significant improvement was noted for variceal ligation alone., Conclusions: compactEASIE simulator training (3 sessions over 7 months), together with clinical endoscopic training resulted in objective improvement in the performance by fellows of all 4 endoscopic hemostatic techniques, whereas significant improvement was noted for variceal ligation alone for fellows who had standard clinical training. In clinical practice, fellows who had intensive simulator/clinical training had a significantly higher success rate and a nonsignificant reduction in the frequency of occurrence of complications.

Background: In 1997 Hochberger and Neumann presented the "Erlangen Biosimulation Model" (commercialized as the "Erlangen Endo-Trainer") at various national and international meetings. The new compactEASIE is a simplified version of the original "Biosimulation Model" (Endo-Trainer) and is specially designed for easy handling. CompactEASIE is reduced in its features, focusing exclusively on flexible endoscopy training. The acceptance of training in endoscopic hemostasis is accepted by workshop participants, as evaluated by a questionnaire on both models., Methods: Eleven structured courses on endoscopic hemostasis for doctors and nurses organized by the same endoscopists from 3/1998 to 5/1999 were evaluated using one of both models. The questionnaires were filled in by 207/291 trainees (71%). The Endo-Trainer was used in 4 (n = 103) and the compactEASIE in 7 courses (n = 104). Both simulators were equipped with identical types of specially prepared pig-organ packages consisting of esophagus, stomach and duodenum, including artificial sewn-in vessels, polyps and varices. Blood perfusion was done with a roller pump connected to the sewn-in vessels and blood surrogate. All workshops were identical concerning the course structure: a 30-min theoretical introduction on ulcer bleeding was followed by 2 h of practical training in injection techniques and hemoclip application. The second part of variceal therapy consisted of a 30-min theoretical introduction prior to 2 h of practical training on sclerotherapy, band ligation and cyanoacrylate application. Finally, a questionnaire on the trainees' pre-experience and their rating of the different workshop sections was handed out to each participant., Results: Previous endoscopic experience was comparable in both groups. The training in both simulators was highly accepted by the trainees (compactEASIE 95% excellent and good versus EASIE (Endo-Trainer) 97%) and did not show any significant difference (P = 0.493). Even in the assessment of the single techniques, no statistical difference was observed. Furthermore, the assessments of the closeness to reality and the endoscopic environment in both simulators were identical., Conclusions: Both simulators (Endo-Trainer, compactEASIE) are excellent educational tools for interventional endoscopy with a high level of acceptance. The easy-to-handle, "lightweight" compactEASIE is a significant, progress tool for the future.

Gastric outlet obstruction as a result of gallstone (Bouveret syndrome) is a rare but serious complication of cholelithiasis. In many cases, surgery has been conducted for treatment. In recent years, minimal invasive treatment modalities (e.g. shockwave lithotripsy) have been shown to be effective in some of those patients. Laserlithotripsy has so far been described in two cases with a Rhodamine-6G dye laser. We present the case of a 90-year-old woman with duodenal obstruction due to a huge gallstone. The patient was referred to our hospital because attempts at endoscopic extraction and extracorporeal shockwave lithotripsy had failed. The man was treated successfully in just one session with a new cost-efficient frequency doubled doublepulse Nd:YAG laser (FREDDY) using a total of 5726 laser pulses (120 mJ pulse energy, 10 Hz pulse repetition rate) and recovered rapidly. Laserlithotripsy can be considered an effective non-invasive therapeutic alternative to surgical treatment in Bouveret's syndrome, especially in old or high-risk patients.

Background: Studies suggest that heparin has anti-inflammatory effects that could prevent acute post-ERCP pancreatitis. The aim of this investigator-initiated, prospective, randomized, double-blind, multicenter study was to determine whether low-molecular-weight heparin can prevent acute post-ERCP pancreatitis., Methods: Patients at increased risk for acute post-ERCP pancreatitis based on assessment of known risk factors were randomized to receive low-molecular-weight heparin (Certoparin 3000 IU subcutaneously) or placebo (saline solution 0.3 mL subcutaneously) the day before ERCP. The drug was given 2 hours before and 22 hours after ERCP. Documentation and follow-up included patient history, risk factors for acute post-ERCP pancreatitis, procedure-related data, assessment of pain (visual analogue scale, need for pain medication), laboratory findings before and after ERCP (0, 4, and 24 hours), as well as post-ERCP complications. The two-sided Fisher exact test was used for statistical comparison, and a p value < or =0.05 was considered significant., Results: A total of 458 patients were enrolled in the study. Data from 10 patients could not be evaluated, leaving 221 patients in the low-molecular-weight heparin group and 227 in the placebo group (total 448 patients; 135 men, 313 women; mean age 58 [15] years). Low-molecular-weight heparin and placebo groups were comparable with regard to risk factors for acute post-ERCP pancreatitis (gender distribution, age <65 years, history of pancreatitis, pancreas divisum, disorders of sphincter of Oddi) and procedure-related data (difficult cannulation, diagnostic or therapeutic ERCP, needle-knife papillotomy, endoscopic sphincterotomy, biliary or pancreatic procedure, pancreatic contrast injection, success and final diagnosis of ERCP). Acute post-ERCP pancreatitis occurred in 8.5% (38/448), with one death resulting from severe pancreatitis. Low-molecular-weight heparin offered no benefit compared with placebo based on the frequency of acute post-ERCP pancreatitis (low-molecular-weight heparin, 18/221 vs. placebo, 20/227; p=0.87) and the severity of acute post-ERCP pancreatitis (low-molecular-weight heparin, 14 mild, 3 moderate, one severe; placebo, 18 mild, two moderate, 0 severe). The 24-hour serum amylase values and 24-hour pain scores did not differ significantly between the low-molecular-weight heparin group and the placebo group. Bleeding complications occurred in two patients, both in the low-molecular-weight heparin group (one mild, one moderate)., Conclusions: Prophylactic subcutaneous administration of low-molecular-weight heparin does not prevent acute post-ERCP pancreatitis.