Interdisciplinary Endoscopy Research Articles

Validation of the ViGaTu Immersive Virtual Reality Endoscopy Training System for Physicians and Nurses.

Endoscopy simulators are primarily designed to provide training in interventions performed during procedures. Peri-interventional tasks such as checking patient data, filling out forms for team time-out, patient monitoring, and performing sedation are often not covered. This study assesses the face, content, and construct validity of the ViGaTu (Virtual Gastro Tutor) immersive virtual reality (VR) simulator in teaching these skills. 71 nurses and physicians were invited to take part in VR training. The participants experienced an immersive VR simulation of an endoscopy procedure, including setting up the endoscopic devices, checking sign-in and team time-out forms, placing monitoring devices, and performing sedation. The actions performed by the participants and their timing were continuously recorded. Face and content validity, as well as the System Usability Scale (SUS), were then assessed. 43 physicians and 28 nurses from 43 centers took a mean of 27.8 min (standard deviation ± 14.42 min) to complete the simulation. Seventy-five percent of the items for assessing face validity were rated as realistic, and 60% of items assessing content validity and usefulness of the simulation for different learning goals were rated as useful by the participants (four out of five on a Likert scale). The SUS score was 70, demonstrating a high degree of usability. With regard to construct validity, experienced endoscopy staff were significantly faster in setting up the endoscope tower and instruments than beginners. This multicenter study presents a new type of interdisciplinary endoscopy training system featuring peri-interventional tasks and sedation in an immersive VR environment.

Increased accuracy of FNA-based cytological diagnosis of pancreatic lesions by use of an ethanol-based fixative system: A STROBE compliant study.

EUS-guided fine needle aspiration cytology (FNA) is the gold standard of evaluation of solid pancreatic lesions. However, accuracy is generally low. The aim of this study was to compare the diagnostic yield of conventional cytology (CC) with liquid-based cytological analysis using an ethanol based fixative system (LBC) without onsite cytopathological assessment. We performed a retrospective evaluation in patients referred to the Department of Interdisciplinary Endoscopy at Jena University Hospital for FNA of pancreatic masses between 2008 and 2015. LBC preservation of specimen was introduced in April 2011. Gold standard was defined as a surgically obtained histology or a patient follow-up of at least 1 year for diagnosis or exclusion of malignancy. 172 patients were included into the final analysis. Mean age was 64.8 years (SD 12.4 years), 105 patients were male. 107 lesions were malignant, while 65 lesions were benign. 89 specimens were evaluated by CC, whereas 83 specimens were processed by LBC. Liquid-based cytology performed significantly better than conventional cytology in terms of sensitivity (87.8% vs 67.2% (P = .021)), specificity (100% vs 87.1% (P = .047)) negative predictive value (NPV) (85% vs 58.7% (P = .009)) and accuracy (92.8% vs 74.2% (P = .001)). We observed no learning curve after implementation of LBC Liquid based cytology is a simple and inexpensive technique that helps improving sensitivity, specificity, NPV and accuracy over conventional cytology in fine needle aspirates from patients with pancreatic lesions. Therefore, this real-world evidence shows, that EUS-FNA specimen processing should be performed using LBC to achieve best possible results.

Analysis of the effects of the first and second/third waves of the COVID-19 pandemic on an Interdisciplinary Endoscopy Unit in a German 'hotspot' area: a single-center experience.

Background:Since December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed a pandemic threat to global health. We are now in the fourth wave of this pandemic. As the pandemic developed, the requirements and therapeutic endoscopic procedures for SARS-CoV-2-positive patients underwent changes.Methods:Analysis of implications for an endoscopy unit during the first and second/third waves of the COVID-19 pandemic with a focus on COVID-19-related process changing. Addressed are number of SARS-CoV-2-positive patients and endoscopic examinations performed in patients who tested positive for SARS-CoV-2 during the various waves, adherence to scheduled examinations, rotation of staff to COVID-dedicated structures and, finally, impact of vaccination on infection rate among endoscopic staff.Results:During the first wave, 10 SARS-CoV-2-positive in-house patients underwent a total of 22 gastrointestinal (GI) endoscopic procedures. During the second and third waves, 59 GI endoscopies were performed in 38 patients. While in the first wave, GI bleeding was the main indication for endoscopy (82%), in the second and third waves the main indication for endoscopy was endoscopic insertion of deep feeding tubes (78%; p < 0.001). During the first wave, 5 (17%) of 29 Interdisciplinary Endoscopy Unit (IEU) staff members were moved to designated COVID wards, which was not necessary during the following waves. Lack of protective clothing was critical during the first wave, but not in the later waves. Screening tests for patients and staff were widely available after the first wave, and IEU staff was vaccinated during the second wave.Conclusion:Strategies to ensure safe endoscopies with respect to preventing transmission of SARS-CoV-2 from patients to staff were effective. Organizational adjustments allowed the routine program to continue unaffected. Indications for GI endoscopies changed over time: during the first wave, GI endoscopies were performed for life-threatening indications, whereas later supportive procedures were the main indication.

Impact of the COVID-19 pandemic on an interdisciplinary endoscopy unit in a German \u201chotspot\u201d area: a single center experience

Background and study aimsSince December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative pathogen of coronavirus disease 2019 (COVID-19), has posed a pandemic threat to global health and has challenged health care system in all affected countries.Patients and methodsThis is a combined study including a descriptive part about the changes in the daily work routine of an Interdisciplinary Endoscopic Unit (IEU) and a prospective analysis of patients tested positive for SARS-CoV-2 who required endoscopic interventions. Conclusively, we present the finding of a point-prevalence analysis in the staff of the IEU.ResultsWe present effects of the COVID-19-related restructuring of processes in our interdisciplinary endoscopy unit (IEU) with respect to cancelation of examinations, relocation of staff to other departments, impact of SARS-CoV-2 on medical staff of the IEU, and supply of protective clothing. Additionally, we analyzed the cohort of COVID-19 patients: Sixteen endoscopic interventions were done in ten patients. In all patients with confirmed infection with SARS-CoV-2, emergency endoscopies were required for relevant bleeding situations. Re-endoscopies were required only in critically ill COVID-19 patients.ConclusionsThe restructuring of processes in the IEU was feasible in short time, effective, and can also be applied broadly at least in developed countries [Garbe et al. in Gastroenterology 159:778–780, 2020; Repici A, Pace F, Gabbiadini R, Colombo M, Hassan C, Dinelli M, Group IG-CW, Maselli R, Spadaccini M, Mutignani M, Gabbrielli A, Signorelli C, Spada C, Leoni P, Fabbri C, Segato S, Gaffuri N, Mangiavillano B, Radaelli F, Salerno R, Bargiggia S, Maroni L, Benedetti A, Occhipinti P, De Grazia F, Ferraris L, Cengia G, Greco S, Alvisi C, Scarcelli A, De Luca L, Cereatti F, Testoni PA, Mingotto R, Aragona G, Manes G, Beretta P, Amvrosiadis G, Cennamo V, Lella F, Missale G, Lagoussis P, Triossi O, Giovanardi M, De Roberto G, Cantu P, Buscarini E, Anderloni A, Carrara S, Fugazza A, Galtieri PA, Pellegatta G, Antonelli G, Rosch T, Sharma P (2020) Endoscopy units and the COVID-19 Outbreak: a Multi-Center Experience from Italy. Gastroenterology;]. The endoscopy-related rate of SARS-CoV-2 infection of staff is low, but supply of protective equipment is crucial for this. Endoscopic procedures in COVID-19 patients were not directly related to SARS-CoV-2 infection, but to other underlying diseases or typical complications of long-term ICU treatment.

Experience of pancreaticobiliary endoscopy fellow in Department of Interdisciplinary Endoscopy, University Medical Center, Hamburg-Eppendorf, Germany

Experience of pancreaticobiliary endoscopy fellow in Department of Interdisciplinary Endoscopy, University Medical Center, Hamburg-Eppendorf, Germany

Endoscopic Treatment of Biliary Stenosis in Patients with Alveolar Echinococcosis--Report of 7 Consecutive Patients with Serial ERC Approach.

Background and AimsBiliary vessel pathology due to alveolar echicococcosis (AE) results in variable combinations of stenosis, necrosis and inflammation. Modern management strategies for patients with cholestasis are desperately needed. The aim is proof of principle of serial ERC (endoscopic retrograde cholangiography) balloon dilation for AE biliary pathology.MethodsRetrospective case series of seven consecutive patients with AE-associated biliary pathology and ERC treatment in an interdisciplinary endoscopy unit at a University Hospital which hosts a national echinococcosis treatment center. The AE patient cohort consists of 106 patients with AE of the liver of which 13 presented with cholestasis. 6/13 received bilio-digestive anastomosis and 7/13 patients were treated by ERC and are reported here. Biliary stricture balloon dilation was performed with 18-Fr balloons at the initial and with 24-Fr balloons at subsequent interventions. If indicated 10 Fr plastic stents were placed.ResultsSix patients were treated by repeated balloon dilation and stenting, one by stenting only. After an acute phase of 6 months with repeated balloon dilation, three patients showed “sustained clinical success” and four patients “assisted therapeutic success,” of which one has not yet reached the six month endpoint. In one patient, sustained success could not be achieved despite repeated insertion of plastic stents and balloon dilation, but with temporary insertion of a fully covered self-expanding metal stent (FCSEMS). There was no loss to follow up. No major complications were observed.ConclusionsSerial endoscopic dilation is a standard tool in the treatment of benign biliary strictures. Serial endoscopic intervention with balloon dilation combined with benzimidazole treatment can re-establish and maintain biliary duct patency in AE associated pathology and probably contributes to avoid or postpone bilio-digestive anastomosis. This approach is in accordance with current ERC guidelines and is minimally disruptive for patients.

Response to Baldaque-Silva et al.

1 Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Correspondence: Daniel von Renteln, MD, Department of Interdisciplinary Endoscopy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. E-mail: [email protected] This letter underwent AJG editorial review.

Sa1607 Endoscopic Full-Thickness Specimens of the Gastrointestinal Wall for the Detection of Neuromuscular Disease

Endoscopic Full-Thickness Specimens of the Gastrointestinal Wall for the Detection of Neuromuscular Disease Annette Fritscher-Ravens*, Mark Ellrichmann, Thilo Wedel, Klaus-GERD Hadeler, Ines Hellwig, Peter J. Milla Internal Medicine I, Interdisciplinary Endoscopy, Kiel, Germany; Anatomy, University Kiel, Kiel, Germany; Animal breeding, Loeffler Institute, Mariensee, Germany; Child Health, University College London, London, United Kingdom Introduction: Gastrointestinal (GI) neuromuscular pathology (GINMP) is associated with a broad spectrum of functional GI disorders, e.g. gastroparesis, slow-transit constipation, intestinal pseudoobstruction. Irritable bowel syndrome (IBS) is now considered to be a related disorder. Diagnosis of GINMP requires full-thickness (FT) specimens (FTS) currently accomplished by laparoscopy. Efforts to construct a device for FTS via endoscopy have not succeeded to date. Aims: 1)To test whether a novel prototype device can obtain FTS of O 1cm from the gut to enable histological analysis of GINMP; 2)to investigate for any complications and damage of adjacent tissues in the peritoneal cavity. Methods: In 30 pigs FTS were taken from the posterior gastric wall. A new modified endoscopic device using a circular cutter within an end cap mounted on the endoscope was used without electrocautery to avoid tissue damage. A metal anchor was pushed to the peritoneal side, the metal cutter pressed against it from the endoluminal side and rotation enabled sampling. The peritoneal anchor also served as abutment to avoid damage of adjacent organs and to retrieve the FTS. Endoscopic t-tags were used for closure. Mini-laparoscopy was performed to inspect the resection site for any damage caused. After 2 weeks survival, peritoneal lavage was performed prior to euthanasia and autopsy. Results: 29/30 procedures were successfully performed; 1 case of bleeding needed endoscopic treatment. All but one FTS were retrieved with the anchor in place. Time to obtain FTS was mean 8.3 min (6.0-15.5 min), for defect closure 18.5 min (range: 7.2-32 min). T-tag closure was successful in all cases. No major complications were seen. Post-procedure laparoscopy proved no other organ damage. Some very minor bleedings were seen in 6/29 cases. The size of FTS was O 9.1 mm with little evidence of edge damage. At autopsy, the scars appeared to have healed well. There was no abscess nor other abnormality. Histology and immunohistochemical work-up proved the presence of well-preserved submucosa and of both the submucosal and myenteric nerve plexus as well as intramuscular nerve fibers. The circular and longitudinal muscle layers were of very good tissue quality. The anchor pushed through the center of the FTS did not substantially alter the quality of the material. Conclusion: Using a new modified prototype endoscopic FTS-device we showed that it was possible to reliably obtain FTS in a quality that provided sufficient tissue for histological analysis of GINMP. All relevant histological and immunohistochemical techniques showed excellent staining qualities required for diagnosing the different subtypes of GINMP. The damage caused with an earlier prototype device was avoided due to the new anchor system. The improved functionality of the device might enable first studies in patients.

Triangulation: the holy grail of endoscopic surgery?

Interventional endoscopy has recently breached the boundaries of the gastrointestinal lumen, entering into the peritoneal cavity to perform natural orifice translumenal endoscopic surgery (NOTES) [1–3]. NOTES is defined as a surgical procedure in which visualization, dissection, and organ retraction is performed with flexible endoscopic instruments through the natural orifices of the body. NOTES is theoretically scarless, and therefore, incisional hernias and associated wound infections are avoided. Other potential benefits include reduced surgical trauma resulting in less postoperative pain and adhesion formation compared with laparoscopic surgery [3]. Currently, no randomized, controlled trial has demonstrated a true advantage of NOTES compared with laparoscopic surgery and the proposed benefits remain speculative. Thus far, and largely in animal laboratories, gastroenterologist and surgeon have opened and closed the gastrointestinal wall, peered into the peritoneal cavity, and demonstrated feasibility of organ resection [4, 5]. Why is it that despite being eager to perform endoscopic intraperitoneal surgery, gastroenterologists and surgeons have only scratched the surface of this novel surgical approach, which is still nowhere near primetime? When experts try to predict how NOTES could function, they normally look at the principles of laparoscopic surgery. Laparoscopic surgery is performed with careful placement of trocars to optimize exposure and to permit triangulation. It is assumed that triangulation is necessary to create traction and countertraction and that this physical principle is what permits appropriate retraction, dissection, or suturing. Accordingly, many experts have suggested that flexible endoscopic surgery will need to emulate the same principles of triangulation to be an effective surgical approach [6, 7]. Several articles have proposed a triangulating endoscope as a key element for the success of NOTES [3, 8–11]. Consequently, NOTES research in recent years has been dominated by major efforts to develop devices and platforms that simulate triangulation and surgical tasks based on how they are performed in the laparoscopic environment. The first patent describing the concept of an endoscope with angulating end-effectors was filed by Mitsui for Olympus as early as 1974 (United States patent number 3,915,157). This patent was subsequently further refined and advanced to a prototype triangulating endoscopic platform filed for patent in 1999 (Matsui et al., United States Patent number 6,352,503). Despite these enduring efforts to build a triangulating endoscopic platform, no such device has become available for clinical use, and those among us who had the opportunity to work with triangulating prototypes have realized that triangulating end-effectors at the tip of a flexible endoscope may have inherited more problems than solutions. Using the flexible translumenal instead of a laparoscopic approach for intraperitoneal surgery does not nullify surgical principles and certain tasks, such as robust organ retraction and classic suturing, will likely require triangulation. There D. von Renteln (&) T. Rosch Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Martinistrase. 52, 20246 Hamburg, Germany e-mail: renteln@gmx.net

Malignant gastroduodenal obstruction: Retrospective comparison of endoscopic and surgical palliative therapy

Introduction. Endoscopic stenting (ES) is a minimally invasive alternative to surgical gastroenterostomy (GE) for palliation of malignant gastroduodenal obstructions. This consecutive, retrospective analysis compares the clinical outcome of all patients undergoing ES or GE in the same period. Methods. ES was performed at the Endoscopy Department, University Hospital Mannheim or at the Interdisciplinary Endoscopy Department, University Hospital Hamburg-Eppendorf. GE was performed at the Surgical Department, University Hospital Mannheim. All palliative ES or GE on patients with malignant gastroduodenal obstruction without earlier gastric resections between January 2001 and April 2007 were evaluated. Main outcome measurements were ability of solid food intake (gastric outlet obstruction score), persistence of nausea and vomiting (gut function score), length of hospital stay, morbidity, mortality and re-interventions. Results. A total of 44 ES and 43 GE were performed. Nausea and vomiting – measured by means of the gut function score – persisted in significantly more patients in the GE group than in those who underwent stent placement (p = 0.0102). The gastric outlet obstruction score at discharge from the hospital revealed no significant difference in the ability of solid food intake between the groups. The hospital stay was significantly longer in the GE group (p = 0.0003). There was no significant difference in mortality and the rates of complications and re-interventions. Conclusion. In this study, ES is a generally equivalent – and in several points superior – alternative to GE for palliation of malignant gastroduodenal obstruction. ES seems to be the less invasive alternative for symptomatic patients. GE has good results in patients with longer survival and can be practiced within abdominal explorations.

Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

BackgroundSedation prior to performance of diagnostic esophagogastroduodenoscopy (EGDE) is widespread and increases patient comfort. But 98% of all serious adverse events during EGDEs are ascribed to sedation. The S3 guideline for sedation procedures in gastrointestinal endoscopy published in 2008 in Germany increases patient safety by standardization. These new regulations increase costs because of the need for more personnel and a prolonged discharge procedure after examinations with sedation. Many patients have difficulties to meet the discharge criteria regulated by the S3 guideline, e.g. the call for a second person to escort them home, to resign from driving and working for the rest of the day, resulting in a refusal of sedation. Therefore, we would like to examine if an acupuncture during elective, diagnostic EGDEs could increase the comfort of patients refusing systemic sedation.Methods/DesignA single-center, double blinded, placebo controlled superiority trial to compare the success rates of elective, diagnostic EGDEs with real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic EGDE who refuse a systemic sedation are eligible. 354 patients will be randomized. The primary endpoint is the rate of successful EGDEs with the randomized technique. Intervention: Real or placebo acupuncture before and during EGDE. Duration of study: Approximately 24 months.DiscussionOrganisation/Responsibility The ACUPEND - Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Interdisciplinary Endoscopy Center (IEZ) of the University Hospital Heidelberg is responsible for design and conduct of the trial, including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI) and the Center of Clinical Trials (KSC) at the Department of General, Visceral and Transplantation Surgery, University of Heidelberg.Trial registrationThe trial is registered at Germanctr.de (DRKS00000164) on December 10th 2009. The first patient was randomized on February 2nd 2010.

Diagnostische Endosonografie – State of the Art 2009

Erste Berichte über die endoluminale Ultraschalldiagnostik liegen 3 Jahrzehnte zurück. Inzwischen hat sich der endoskopische Ultraschall (EUS) von einer experimentellen Außenseiter­methode zu einer in Gastroenterologie, Visze­ralchirurgie, Pneumologie, Endokrinologie und ­Onkologie unverzichtbaren Methode etablieren können und gilt heute als interdisziplinäre „Königs­disziplin“ der Endoskopie [1]. Ein ent­schei­dender Meilenstein dieser Entwicklung war die Einführung elektronischer Longitudinalscanner als Voraussetzung für die endosonografisch gestützte Biopsie. Elektronische Longitudinal- und Radialscanner ermöglichten es darüber hinaus, innovative Ultraschalltechnologien wie farbkodierte Duplexsonografie, echosignalver­stärkte Sonografie und die Realtime-Elastografie auch endoluminal einzusetzen. Die Akzeptanz des EUS im klinischen Alltag gründet sich auf eine überzeugende wissenschaftliche Evidenz in den etablierten Indikationsgebieten und auf eine breite Verfügbarkeit in hoher Qualität. In Deutschland werden strukturierte Ausbildungscurricula und die vergleichende Bewertung der Ergebnisqualität (Benchmarking) helfen, den klinischen Stellenwert des EUS zu festigen.

Quality control of endoscopic ultrasound in preoperative staging of esophageal cancer

Endoscopic ultrasonography (EUS) is generally established as the most sensitive diagnostic tool for the assessment of locoregional tumor stage in esophageal carcinoma. It therefore has a crucial impact on the decision whether patients should undergo surgery as primary treatment or should receive neoadjuvant therapy. This study retrospectively evaluates the accuracy of EUS in tumor and nodal staging of prospectively evaluated patients with esophageal carcinoma in relation to tumor type, tumor grading, tumor site, and the influence of dilation. All 214 patients included in the study underwent surgery without neoadjuvant therapy and had tumor-free resection margins with no evidence of distant metastasis. EUS investigations were done at our Department of Interdisciplinary Endoscopy. EUS results were compared with the pathological findings. EUS correctly identified T status in 141 patients (65.9 %). The sensitivity and specificity in relation to T status were 68.1 % and 98.2 % respectively for T1, 40.9 % and 83.4 % for T2, 84.3 % and 64.6 % for T3, and 14.3 % and 98.8 % for T4. The overall diagnostic accuracy of EUS in relation to N status was 64.5 % (n = 138); sensitivity and specificity for the diagnosis of N1 were 93.8 % and 20 %, respectively. Sixty-eight (80 %) of 85 pN0-staged tumors were overstaged as uN1. Dilation had a significant influence on the accuracy of EUS staging in advanced tumors ( P = 0.02), whereas tumor grading impacted on EUS staging in early tumors ( P = 0.01). Tumor site and tumor type did not show any influence. Endosonographic staging of esophageal carcinoma is still unsatisfactory. An improvement in staging accuracy may be achieved by adding fine-needle aspiration biopsy (FNA) to EUS, because FNA improves N-stage accuracy, but it has no bearing on T-stage accuracy.

Tissue glue for the endoscopist: Healing by sealing

Tissue glue for the endoscopist: Healing by sealing

Timing of emergency ERCP and treatment procedures in acute biliary pancreatitis: [formula omitted], A. Adler, K.E. Hampel, R.E. Hintze. Central Interdisciplinary Endoscopy, Dept. of Gastroenterology, University Hospital Rudolf Virchow, Free University of Berlin, Germany

Timing of emergency ERCP and treatment procedures in acute biliary pancreatitis: [formula omitted], A. Adler, K.E. Hampel, R.E. Hintze. Central Interdisciplinary Endoscopy, Dept. of Gastroenterology, University Hospital Rudolf Virchow, Free University of Berlin, Germany

Significance of ERC and computed tomography (CT) imaging in diagnosing primary sclerosing cholangitis (PSC): [formula omitted], F.D. Knollmann∗, W. Veltzke, K.E. Hampel, R. Felix∗, R.E. Hintze. Central Interdisciplinary Endoscopy, Depts. of Gastroenterology and ∗Radiology, University Hospital Rudolf Virchow, Free University of Berlin, Germany

Significance of ERC and computed tomography (CT) imaging in diagnosing primary sclerosing cholangitis (PSC): [formula omitted], F.D. Knollmann∗, W. Veltzke, K.E. Hampel, R. Felix∗, R.E. Hintze. Central Interdisciplinary Endoscopy, Depts. of Gastroenterology and ∗Radiology, University Hospital Rudolf Virchow, Free University of Berlin, Germany