Safety of endoscopist-guided sedation in a low-risk collective.

INTRODUCTION: Worldwide, gastrointestinal endoscopies are predominantly performed under sedation. National and international guidelines and recommendations contain very different specifications for the use of sedation in gastrointestinal endoscopy. These differences come from specific requirements for staffing during endoscopy. AIM: The aim of the study is to evaluate whether endoscopist-guided sedation without additional sedation assistance is not inferior to endoscopist-guided sedation with additional sedation assistance with respect to the rate of sedation-associated complications in a defined low-risk population (low-risk procedure and low-risk patient). METHODS: Prospective, multicenter, randomized study. RESULTS: 27 German study centers participated in the study. A total of 30 569 endoscopies were recorded during the study period from 1.8.2015 to 10.3.2020. The final data analysis included 28 673 examinations (64.1 % esophagosgastroduodenoscopies and 35.9 % colonoscopies). In 307 (1.1 %) examinations, 322 sedation-associated complications occurred. Of these, 321 (1.1 %) were minor complications and one (0.003 %) was a major complication. There was no statistically significant difference in the frequency of sedation-associated complications between endoscopist-guided sedation with versus without additional sedation assistance. Within the legal framework, a "shadow" sedation assistant was present in the study group without sedation assistance. This assistant intervened because of sedation-associated complications in 101 (0.7 %) of the endoscopies. CONCLUSION: The study documents the safety of propofol-based endoscopist-guided sedation in a low-risk population. In 98.9 % of all endoscopies, no sedation-associated complication occurred or it was so minimal that no intervention (e. g., increase of oxygen supply) was necessary. The study cannot answer to what extent a serious complication was avoided by the active intervention of the "shadow" sedation assistance in the group without sedation assistance.The study proves in a randomized, prospective design that sedation in low-risk endoscopy (low-risk patient, low-risk procedure) can be performed as endoscopist-guided sedation without additional sedation assistance, without demonstrably accepting a reduction in safety.

[The gastroenterology during the first and second wave of corona pandemic - two surveys by the working group of the guiding gastroenterologic clinicians (ALGK)]. / Die Gastroenterologie in der ersten und zweiten Corona-Welle ­ zwei Umfragen der Arbeitsgemeinschaft Leitender Gastroenterologischer Krankenhausärzte (ALGK).

BACKGROUND: An evaluation of the non-university hospitals in Germany with regard to the actual and follow-up working condition, alterations and perspectives during the Corona-crisis is missing. The working group of the guiding gastroenterologic clinicians (ALGK) comprises more than 70% of the head physicians of gastroenterological units leading to representative informations. METHODS: The ALGK conducted two surveys among its members in 2020 during the first and 2021 during the second Corona-wave. 369 members with correct email adresses were contacted. The first survey included 17 and the second survey 21 questions. RESULTS: 58 % of the respondent represented primary and standard care hospitals, 36 % secondary care hospitals, 6 % tertiary hospitals of maximum care, 43 % communal, 38 % confessional and 18 % private hospitals. 87 % of the respondent reported about cancellation of the hospital appointments by the patients (87 %/85 %). In the second survey, appointment cancellation by the physican (58 % vs. 84 %), reduction of emergency cases (16 % vs. 29 %), postponement of diagnostic or therapeutic appointments (85 % vs. 99 %) and reduction of programmed inpatient (65 vs. 91 %) or outpatient treatment (15 % vs. 84 %) were lesser compared to the first survey. Mean reduction of endoscopic procedures per unit were 337/month to 151/month (55 %) for diagnostic endoscopy, 174/month to 84/month (52 %) for therapeutic endoscopy and 56/month to 7/month (87,5 %) for prevention colonoscopy. The comparison between hospital operators revealed more reports on staff to be under quarantine, more very strong or strong feeling of psychological stress, more fear of corona-infection and more suspicion of ambulatory maintenance in gastroenterology in private hospitals. Willingness for vaccination was very high among physicians and nursing staff (92 %/89 %) and not different between the hospital operators. 38 % of the repsondent reported on the fear of existential risk of their hospital because of the Corona-crisis. CONCLUSION: The two ALGK surveys give a reprensentative picture of the situation of non-university gastroenterological units during Corona-pandemic in Germany.

Acute sedation-associated complications in GI endoscopy (ProSed 2 Study): results from the prospective multicentre electronic registry of sedation-associated complications.

OBJECTIVES: Sedation has been established for GI endoscopic procedures in most countries, but it is also associated with an added risk of complications. Reported complication rates are variable due to different study methodologies and often limited sample size. DESIGNS: Acute sedation-associated complications were prospectively recorded in an electronic endoscopy documentation in 39 study centres between December 2011 and August 2014 (median inclusion period 24 months). The sedation regimen was decided by each study centre. RESULTS: A total of 368 206 endoscopies was recorded; 11% without sedation. Propofol was the dominant drug used (62% only, 22.5% in combination with midazolam). Of the sedated patients, 38 (0.01%) suffered a major complication, and overall mortality was 0.005% (n=15); minor complications occurred in 0.3%. Multivariate analysis showed the following independent risk factors for all complications: American Society of Anesthesiologists class >2 (OR 2.29) and type and duration of endoscopy. Of the sedation regimens, propofol monosedation had the lowest rate (OR 0.75) compared with midazolam (reference) and combinations (OR 1.0-1.5). Compared with primary care hospitals, tertiary referral centres had higher complication rates (OR 1.61). Notably, compared with sedation by a two-person endoscopy team (endoscopist/assistant; 53.5% of all procedures), adding another person for sedation (nurse, physician) was associated with higher complication rates (ORs 1.40-4.46), probably due to higher complexity of procedures not evident in the multivariate analysis. CONCLUSIONS: This large multicentre registry study confirmed that severe acute sedation-related complications are rare during GI endoscopy with a very low mortality. The data are useful for planning risk factor-adapted sedation management to further prevent sedation-associated complications in selected patients. TRIAL REGISTRATION NUMBER: DRKS00007768; Pre-results.

Long-term efficacy and safety of endoscopic resection for patients with mucosal adenocarcinoma of the esophagus.

BACKGROUND & AIMS: Barrett's esophagus-associated high-grade dysplasia is commonly treated by endoscopy. However, most guidelines offer no recommendations for endoscopic treatment of mucosal adenocarcinoma of the esophagus (mAC). We investigated the efficacy and safety of endoscopic resection in a large series of patients with mAC. METHODS: We collected data from 1000 consecutive patients (mean age, 69.1 ± 10.7 years; 861 men) with mAC (481 with short-segment and 519 with long-segment Barrett's esophagus) who presented at a tertiary care center from October 1996 to September 2010. Patients with low-grade and high-grade dysplasia and submucosal or more advanced cancer were excluded. All patients underwent endoscopic resection of mACs. Patients found to have submucosal cancer at their first endoscopy examination were excluded from the analysis. RESULTS: After a mean follow-up period of 56.6 ± 33.4 months, 963 patients (96.3%) had achieved a complete response; surgery was necessary in 12 patients (3.7%) after endoscopic therapy failed. Metachronous lesions or recurrence of cancer developed during the follow-up period in 140 patients (14.5%) but endoscopic re-treatment was successful in 115, resulting in a long-term complete remission rate of 93.8%; 111 died of concomitant disease and 2 of Barrett's esophagus-associated cancer. The calculated 10-year survival rate of patients who underwent endoscopic resection of mACs was 75%. Major complications developed in 15 patients (1.5%) but could be managed conservatively. CONCLUSIONS: Endoscopic therapy is highly effective and safe for patients with mAC, with excellent long-term results. In an almost 5-year follow-up of 1000 patients treated with endoscopic resection, there was no mortality and less than 2% had major complications. Endoscopic therapy should become the standard of care for patients with mAC.

Ablation of residual Barrett's epithelium after endoscopic resection: a randomized long-term follow-up study of argon plasma coagulation vs. surveillance (APE study).

BACKGROUND AND STUDY AIM: It is commonly assumed that ablation of any remaining Barrett's epithelium after endoscopic resection of early Barrett's neoplasia improves outcome by reducing the rate of metachronous lesions, but this has not yet been evaluated in a randomized trial. The aim of this study was to compare argon plasma coagulation (APC) with surveillance only for the management of residual Barrett's epithelium following endoscopic resection. PATIENTS AND METHODS: Patients in whom focal early Barrett's neoplasia (high grade intraepithelial neoplasia [HGIN] or mucosal cancer) had been curatively resected by endoscopy were randomly assigned to undergo ablation of the residual Barrett's segment by APC or surveillance only; pH-metry-adjusted proton pump inhibitor therapy was administered in both groups. The main outcome parameter was recurrence-free survival. Follow-up endoscopies with biopsies in cases of further residual Barrett's epithelium were carried out at 6-monthly intervals in both groups. RESULTS: A total of 63 patients (57 male [90.5%]) were included in the study (ablation group n=33; surveillance group n=30). For complete Barrett's ablation, a mean number of 4±1.6 APC sessions were required (range 2-7). The mean follow-up duration did not differ significantly between ablation (28.2±13.7 months, range 0-44) and surveillance patients (24.7±14.8 months, range 0-45; P=0.159). The number of secondary lesions was 1 in the ablation group (3%), and 11 in the surveillance group (36.7%), leading to significantly higher recurrence-free survival for the patients undergoing ablation (P=0.005). CONCLUSIONS: Thermal ablation of residual Barrett's epithelium leads to a significant reduction in neoplasia recurrence rate compared with a surveillance strategy during a limited follow-up of 2 years. A longer follow-up duration may have led to a relatively higher rate of secondary neoplasia in both groups of patients.

Efficacy, safety, and long-term results of endoscopic treatment for early stage adenocarcinoma of the esophagus with low-risk sm1 invasion.

BACKGROUND & AIMS: Patients with early-stage mucosal (T1a) esophageal adenocarcinoma (EAC) are increasingly treated by endoscopic resection. EACs limited to the upper third of the submucosa (pT1b sm1) could also be treated by endoscopy. We assessed the efficacy, safety, and long-term effects of endoscopic therapy for these patients. METHODS: We analyzed data from 66 patients with sm1 low-risk lesions (macroscopically polypoid or flat, with a histologic pattern of sm1 invasion, good-to-moderate differentiation [G1/2], and no invasion into lymph vessels or veins) treated by endoscopic therapy at the HSK Hospital Wiesbaden from 1996 through 2010. The efficacy of endoscopic therapy was assessed on the basis of rates of complete endoluminal remission (CER), metachronous neoplasia, lymph node events, and long-term remission (LTR). Safety was assessed on the basis of rate of complications. RESULTS: Remissions were assessed in 61 of the 66 patients; 53 of the 61 achieved CER (87%). Of patients with small focal neoplasias ≤2 cm, 97% achieved CER (for those with tumors ≥2 cm, 77%; P = .026). Metachronous neoplasias were observed in 10 of 53 patients (19%; 9 of the 10 underwent repeat endoscopic resection). One patient developed a lymph node metastasis (1.9%). Fifty-one patients achieved LTR (84%); 90% of those with focal lesions ≤2 cm achieved LTR after a mean follow-up period of 47 ± 29.1 months (range, 8-120 months). No tumor-associated deaths were observed, and the estimated 5-year survival rate was 84%. The rate of major complications from endoscopic resection was 1.5%, and no patients died. CONCLUSIONS: Endoscopic therapy appears to be a good alternative to esophagectomy for patients with pT1b sm1 EAC, on the basis of macroscopic and histologic analyses. The risk of developing lymph node metastases after endoscopic resection for sm1 EAC is lower than the risk of surgery.

Prospective randomized comparison of short-access mother-baby cholangioscopy versus direct cholangioscopy with ultraslim gastroscopes.

BACKGROUND: Mother-baby technologies, the criterion standard for cholangioscopy, have several limitations. A novel, short-access, mother-baby (SAMBA) system may improve this technique. Direct cholangioscopy (DC) was recently developed as an alternative to mother-baby cholangioscopy. OBJECTIVE: Comparison of success rates with SAMBA and DC. DESIGN: Single-center, randomized, controlled trial. SETTING: Academic tertiary-care referral center. PATIENTS: Sixty patients with suspected cholangiopathies randomized to either SAMBA (n = 30) or DC (n = 30). INTERVENTION: Cholangioscopy under deep sedation. MAIN OUTCOME MEASUREMENTS: Technical success rate of diagnostic or therapeutic procedure. RESULTS: A total of 24 and 21 diagnostic procedures were performed in the SAMBA and DC groups, respectively. There were no significant differences in the overall technical success rates between SAMBA (90.0%) and DC (86.7%) (P = 1.0). There was better correlation between the endoscopic prediction and histologic findings in DC (P = .013). Procedure times were shorter in DC (P < .03). In patients without significant stenoses, SAMBA allowed intrahepatic bile duct exploration in all cases, compared with 10.5% of cases in DC (P < .01). No differences regarding adverse event rates between the groups occurred (10.0% both groups). LIMITATIONS: Small sample size. Heterogeneous indications for cholangioscopy. DC requires advanced skills of the endoscopist. The study is not replicable. CONCLUSION: SAMBA and DC offer high technical success rates for diagnostic and therapeutic interventions. The advantages of DC consist of superior imaging, shorter total procedure time, and a wider working channel for adequate tissue sampling. SAMBA is better than DC with regard to intraductal stability and accessibility of the intrahepatic bile ducts.

[The abdominal pain unit as a treatment pathway : Structured care of patients with atraumatic abdominal pain in the emergency department]. / Die Abdominal Pain Unit als Behandlungspfad : Strukturierte Versorgung von Patient*innen mit atraumatischen Bauchschmerzen in der Notaufnahme.

BACKGROUND: Patients with atraumatic abdominal pain are common in the emergency department and have a relatively high hospital mortality, with a very wide spectrum of different causes. Rapid, goal-directed diagnosis is essential in this context. METHODS: In a Delphi process with representatives of different disciplines, a diagnostic treatment pathway was designed, which is called the Abdominal Pain Unit (APU). RESULTS: The treatment pathway was designed as an extended event process chain. Crucial decision points were specified using standard operating procedures. DISCUSSION: The APU treatment pathway establishes a consistent treatment structure for patients with atraumatic abdominal pain. It has the potential to improve the quality of care and reduce intrahospital mortality over the long term.

Detection of Viral Infection and Bacterial Coinfection and Superinfection in Coronavirus Disease 2019 Patients Presenting to the Emergency Department Using the 29-mRNA Host Response Classifier IMX-BVN-3: A Multicenter Study.

Background: Identification of bacterial coinfection in patients with coronavirus disease 2019 (COVID-19) facilitates appropriate initiation or withholding of antibiotics. The Inflammatix Bacterial Viral Noninfected (IMX-BVN) classifier determines the likelihood of bacterial and viral infections. In a multicenter study, we investigated whether IMX-BVN version 3 (IMX-BVN-3) identifies patients with COVID-19 and bacterial coinfections or superinfections. Methods: Patients with polymerase chain reaction-confirmed COVID-19 were enrolled in Berlin, Germany; Basel, Switzerland; and Cleveland, Ohio upon emergency department or hospital admission. PAXgene Blood RNA was extracted and 29 host mRNAs were quantified. IMX-BVN-3 categorized patients into very unlikely, unlikely, possible, and very likely bacterial and viral interpretation bands. IMX-BVN-3 results were compared with clinically adjudicated infection status. Results: IMX-BVN-3 categorized 102 of 111 (91.9%) COVID-19 patients into very likely or possible, 7 (6.3%) into unlikely, and 2 (1.8%) into very unlikely viral bands. Approximately 94% of patients had IMX-BVN-3 unlikely or very unlikely bacterial results. Among 7 (6.3%) patients with possible (n = 4) or very likely (n = 3) bacterial results, 6 (85.7%) had clinically adjudicated bacterial coinfection or superinfection. Overall, 19 of 111 subjects for whom adjudication was performed had a bacterial infection; 7 of these showed a very likely or likely bacterial result in IMX-BVN-3. Conclusions: IMX-BVN-3 identified COVID-19 patients as virally infected and identified bacterial coinfections and superinfections. Future studies will determine whether a point-of-care version of the classifier may improve the management of COVID-19 patients, including appropriate antibiotic use.

Water infusion for cecal intubation increases patient tolerance, but does not improve intubation of unsedated colonoscopies.

BACKGROUND & AIMS: Several studies have indicated that water infusion, instead of air insufflation, enhances cecal intubation in selected patients undergoing unsedated colonoscopy. We performed a prospective, randomized, controlled trial to investigate whether the water technique increases the proportion of patients that are able to complete unsedated colonoscopy. METHODS: We analyzed data from 116 consecutive outpatients who were willing to start colonoscopy without sedation; 58 were each randomly assigned to groups given water infusion or air insufflation during the insertion phase. Sedation and analgesia were administered on demand. RESULTS: Fewer patients requested sedation in the water group (8.6%) than in the air group (34.5%; P = .003) and their maximum pain scores were lower (2.8 ± 1.9 vs 4.2 ± 2.3 in the air group; P = .011). However, differences in percentages of patients who received complete, unsedated colonoscopy between the water group (74.1%) and air group (62.1%) did not reach statistical significance (P = .23); the percentage of successful cecal intubations was lower in the water group (82.8%) than in the air group (96.5%; P = .03) because of poor visibility. Failed procedures in the water group were completed successfully after air insufflation. The cecal intubation time was shorter in the air group (6.2 ± 3.4 min) than in the water group (8.1 ± 3.0 min; P = .01). CONCLUSIONS: In patients willing to undergo unsedated colonoscopy, water infusion improves patient tolerance for cecal intubation, compared with air insufflation. However, it does not increase the overall percentage of successful cecal intubations because suboptimal bowel preparation interferes with visibility.

Diagnostics and Early Diagnosis of Esophageal Cancer.

In the esophagus two different kinds of primary neoplasias may arise: squamocellular carcinomas (SCC) and esophageal adenocarcinomas (EAC). Although both types of carcinoma are rare diseases, especially the incidence of EAC rose in the last years. The management of esophageal cancer is challenging. There are no specific symptoms of early esophageal cancers. Due to this fact, most of the esophageal cancers are found incidentally, and only 12.5% of esophageal tumors are endoscopically resectable. Gastroscopy is the gold standard for the diagnosis of esophageal cancer. The sensitivity of detecting early-stage carcinoma may be improved by adjunct techniques such as chromoendoscopy, virtual chromoendoscopy, magnification endoscopy, and other advanced endoscopic imaging techniques. The diagnosis of esophageal cancer can be verified with targeted biopsies. Accurate staging information is crucial for establishing appropriate treatment choices for esophageal cancer, while the depth of the tumor determines the feasibility of therapy. In terms of staging, endosonography, abdominal ultrasound, and computed tomography scan of the thorax and abdomen should thus be performed before initiation of therapy.

Perioperative and Palliative Chemotherapy for Esophageal Cancer.

Perioperative and palliative chemotherapy for esophageal carcinoma has undergone substantial changes in recent years. The implementation of trastuzumab in the treatment of HER2-positive advanced adenocarcinoma is a milestone as it marked the introduction of the first molecularly targeted treatment of gastric cancer. Current studies are investigating whether anti-HER2-directed treatment also proves effective in the perioperative setting. Data from the CROSS study on neoadjuvant radio-/chemotherapy with paclitaxel and carboplatin have helped to establish a new standard of care for the treatment of localized esophageal cancer. Finally, preliminary experience in potentially curative treatment approaches for oligometastatic tumor stages may offer new treatment options for patients with stage IV gastric cancer. However, some of these innovative approaches urgently require validation in larger, prospective, and controlled multicenter studies. Highly active forms of radiotherapy, radio-/chemotherapy, or chemoimmunotherapy can achieve complete tumor remissions in some patients. Despite these advances, life expectancy unfortunately continues to be very limited in the majority of patients with locally advanced or metastatic esophageal carcinoma.

Verrucous Oesophageal Carcinoma: Single Case Report and Case Series Including 15 Patients - Issues for Consideration of Therapeutic Strategies.

BACKGROUND: Verrucous carcinomas (VC) of the oesophagus are a rarity. Due to their histological resemblance to squamous cell carcinoma, the diagnostic and treatment standards applicable to the latter have so far also been applied to VC as a disease entity. Quite limited data are available including two case series of 5 or 11 patients. The present study reports on a single case treated by local endoscopic therapy and a series of 15 patients, 9 of whom received local endoscopic therapy. METHODS: The data for patients diagnosed with VC of the oesophagus who had been treated from January 1999 to May 2011 were analysed retrospectively. RESULTS: 15 patients with the diagnosis of oesophageal VC were included. The male-female ratio was 3:1. 9 of 11 pT1-VC patients presented with the cardinal symptom dysphagia or odynophagia. For the majority of the patients, the growth pattern is one of extensive superficial expansion showing a median length of 9 cm (range: 2-22 cm). Surprisingly, none of the VC patients showed lymph node or distant metastasis. 9 of 15 VC patients received local endoscopic therapy; 4 were treated with curative intent and 5 were treated palliatively. 3 patients underwent oesophageal resection, and definitive chemoradiotherapy was administered in a further 3 patients. One severe complication, consisting of a postoperative anastomotic insufficiency with a fatal outcome, occurred in this group of patients. CONCLUSION: This is the largest published study describing patients diagnosed with VC of the oesophagus so far. The option of local endoscopic therapy and its results in 9 patients are reported for the first time. The superficial growth pattern of the tumour and the frequent absence of lymph node or distant metastasis suggest that endoscopic resection can be carried out as a diagnostic and/or therapeutic approach. Due to the rarity of this entity, the case numbers are unfortunately so limited that evidence-based recommendations are unlikely to become available even in the future.

Barrett's adenocarcinoma of the esophagus: better outcomes through new methods of diagnosis and treatment.

BACKGROUND: Esophageal adenocarcinoma has attracted more attention among gastroenterologists recently because of its rapidly rising incidence in Western countries. Many new epidemiological findings have been published, and there have been numerous technical advances in diagnostic procedures and in multimodal treatment based on the staging of the disease. METHODS: In this paper, we selectively review the literature on esophageal adenocarcinoma, also considering the evidence-based recommendations contained in the guidelines of the German Society for Digestive and Metabolic Diseases (Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten, DGVS) as well as the latest data from our own research team. RESULTS AND CONCLUSION: here have been major recent advances in the diagnosis and treatment of esophageal adenocarcinoma. New refinements in endoscopic techniques now make endoscopic treatment possible for early esophageal carcinoma. New surgical techniques and new strategies of neoadjuvant chemotherapy have lowered the morbidity and improved the outcome of patients with locally advanced disease. Molecular therapies, too, have shown promising initial results.

Curative endoscopic resection of early esophageal adenocarcinomas (Barrett's cancer).

BACKGROUND: In view of the increasing incidence of adenocarcinoma in Barrett's esophagus and the mortality and high morbidity rates associated with surgical therapy for this condition, safe and effective but less invasive methods of treatment are needed. OBJECTIVE: To evaluate efficacy and safety of endoscopic resection in these patients. DESIGN: Single-center prospective study. SETTING: Teaching hospital, conducted between October 1996 and September 2003. PATIENTS: A total of 100 consecutive patients (mean age, 62.1 +/- 10.9 years; range, 31-86 years) with low-risk adenocarcinoma of the esophagus (macroscopic types I, IIa, IIb, and IIc; lesion diameter up to 20 mm; mucosal lesion without invasion into lymph vessels and veins; and histologic grades G1 and G2) arising in Barrett's metaplasia. INTERVENTIONS: Endoscopic resection with the suck-and-cut technique. MAIN OUTCOME MEASUREMENTS: Complete local remission. RESULTS: A total of 144 resections (1.47 per patient) were performed without technical problems. No major complications and only 11 minor ones (bleedings without decrease of Hb >2 g/dL; treated with injection therapy) occurred. Complete local remission was achieved in 99 of the 100 patients after 1.9 months (range, 1-18 months) and a maximum of 3 resections. During a mean follow-up period of 36.7 months, recurrent or metachronous carcinomas were found in 11% of the patients, but successful repeat treatment with endoscopic resection was possible in all of these cases. The calculated 5-year survival rate was 98%. Two patients died of other causes. LIMITATIONS: Nonblinded, nonrandomized study. CONCLUSIONS: Endoscopic resection is associated with favorable outcomes for low-risk patients with early esophageal adenocarcinoma (Barrett's carcinoma).