Utility of interventional endoscopic ultrasound in pancreatic cancer.

Endoscopic ultrasound (EUS) has an important role in the management algorithm of patients with pancreatic ductal adenocarcinoma (PDAC), typically for its diagnostic utilities. The past two decades have seen a rapid expansion of the therapeutic capabilities of EUS. Interventional EUS is now one of the more exciting developments within the field of endoscopy. The local effects of PDAC tend to be in anatomical areas which are difficult to target and endoscopy has cemented itself as a key role in managing the clinical sequelae of PDAC. Interventional EUS is increasingly utilized in situations whereby conventional endoscopy is either impossible to perform or unsuccessful. It also adds a different dimension to the host of oncological and surgical treatments for patients with PDAC. In this review, we aim to summarize the various ways in which interventional EUS could benefit patients with PDAC and aim to provide a balanced commentary on the current evidence of interventional EUS in the literature.

UK ERCP sedation practices, patient comfort and endoscopist characteristics: National Endoscopy Database (NED) analysis on behalf of the JAG and BSG.

Objectives: This analysis assessed current endoscopic retrograde cholangiopancreatography (ERCP) practice within the UK, including use of sedation and patient comfort. Methods: ERCPs conducted over 1 year (1 July 2021-30 June 2022) and uploaded to the National Endoscopy Database (NED) were analysed. The endoscopist workforce was classified by gender and specialty, use of sedation was analysed. Logistic regression was used to assess associations between patient age, gender and procedure indications on moderate to severe discomfort risk. Results: 27 812 ERCPs were performed by 491 endoscopists in 175 sites and uploaded to NED, an estimated 50% of total UK activity. 13% were training procedures, 94% of the endoscopists were male, with 72% being gastroenterologists. Most ERCPs were performed under conscious sedation (89%). The discomfort rate among patients aged 60-90 undergoing ERCP under conscious sedation was 4.2% (95% CI 3.9% to 4.5%), with only 5.5% (95% CI 5.2% to 5.9%) receiving greater than 5 mg midazolam or 100 µg fentanyl.Younger patients (<30 years) had a higher discomfort risk during conscious sedation ERCPs than those aged 70-79 (OR 3.0, 95% CI 2.2 to 4.3, p<0.05), while male patients had a lower discomfort risk compared with females (OR 0.9, 95% CI 0.8 to 1.0, p=0.05).Enhanced sedation (propofol or general anaesthetic) was associated with lower frequency of discomfort (0.3%, 95% CI 0.1 to 0.6) compared with conscious sedation (5.1%, 95% CI 4.9% to 5.4%, p<0.05). Conclusions: Conscious sedation is well tolerated for most patients and prescribing practices have improved. However, triage of more patients, particularly young females, to enhanced sedation lists should be considered to reduce discomfort rates in future.

Informed consent for endoscopic procedures: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

All endoscopic procedures are invasive and carry risk. Accordingly, all endoscopists should involve the patient in the decision-making process about the most appropriate endoscopic procedure for that individual, in keeping with a patient's right to self-determination and autonomy. Recognition of this has led to detailed guidelines on informed consent for endoscopy in some countries, but in many no such guidance exists; this may lead to variations in care and exposure to risk of litigation. In this document, the European Society of Gastrointestinal Endoscopy (ESGE) sets out a series of statements that cover best practice in informed consent for endoscopy. These statements should be seen as a minimum standard of practice, but practitioners must be aware of and adhere to the law in their own country. 1: Patients should give informed consent for all gastrointestinal endoscopic procedures for which they have capacity to do so. 2: The healthcare professional seeking consent for an endoscopic procedure should ensure that the patient has the capacity to consent to that procedure. 3: For patients who lack capacity, healthcare personnel should at all times try to engage with people close to the patient, such as family, friends, or caregivers, to achieve consensus on the appropriateness of performing the procedure. 4: Where a patient lacks capacity to provide informed consent, the best interest decision should be clearly documented in the medical record. This should include information about the capacity assessment, reason(s) that the decision cannot be delayed for capacity recovery (or if recovery is not expected), who has been consulted, and where relevant the form of authority for the decision. 5: There should be a systematic and transparent disclosure of the expected benefits and harms that may reasonably affect patient choice on whether or not to undergo any diagnostic or interventional endoscopic procedure. Information about possible alternatives, as well as the consequences of doing nothing, should also be provided when relevant. 6: The information provided on the benefit and harms of an endoscopic procedure should be adapted to the procedure and patient-specific risk factors, and the preferences of the patient should be central to the consent process. 7: The consent discussion should be undertaken by an individual who is familiar with the procedure and its risks, and is able to discuss these in the context of the individual patient. 8: Patients should confirm consent to an endoscopic procedure in a private, unrushed, and non-coercive environment. 9: If a patient requests that an endoscopic procedure be discontinued, the procedure should be paused and the patient's capacity for decision making assessed. If a competent patient continues to object to the procedure, or if a conclusive determination of capacity is not feasible, the examination should be terminated as soon as it is safe to do so. 10: Informed consent should be sufficiently detailed to cover all findings that can be reasonably anticipated during an endoscopic examination. The scope of this consent should not be expanded, nor a patient's implicit consent for additional interventions assumed, unless failure to proceed with such interventions would result in immediate and predictable harm to the patient.

Individualised consent for endoscopy: update on the 2016 BSG guidelines.

In 2016, the British Society of Gastroenterology (BSG) published comprehensive guidelines for obtaining consent for endoscopic procedures. In November 2020, the General Medical Council (GMC) introduced updated guidelines on shared decision making and consent. These guidelines followed the Montgomery ruling in 2015, which changed the legal doctrine determining what information should be given to a patient before a medical intervention. The GMC guidance and Montgomery ruling expand on the role of shared decision making between the clinician and patient, explicitly highlighting the importance of understanding the values of the patient. In November 2021, the BSG President's Bulletin highlighted the 2020 GMC guidance and the need to incorporate patient -related factors into decision making. Here, we make formal recommendations in support of this communication, and update the 2016 BSG endoscopy consent guidelines. The BSG guideline refers to the Montgomery legislation, but this document expands on the findings and gives proposals for how to incorporate it into the consent process. The document is to accompany, not replace the recent GMC and BSG guidelines. The recommendations are made in the understanding that there is not a single solution to the consent process, but that medical practitioners and services must work together to ensure that the principles and recommendations laid out below are deliverable at a local level. The 2020 GMC and 2016 BSG guidance had patient representatives involved throughout the process. Further patient involvement was not sought here as this update is to give practical advice on how to incorporate these guidelines into clinical practice and the consent process. This document should be read by endoscopists and referrers from primary and secondary care.

EUS-guided through the needle microbiopsy: a useful adjunct in the investigation of pancreatic cystic lesions.

OBJECTIVE: Endoscopic ultrasound-guided through-the-needle microbiopsy (EUS-TTNB) forceps is a recent development that facilitates sampling of the walls of pancreatic cystic lesions (PCL) for histological analysis. We aimed to assess the impact of EUS-TTNB and its influence on patient management in a tertiary pancreas centre. DESIGN: A prospective database of consecutive patients who underwent EUS-TTNB from March 2020 to August 2022 at a tertiary referral centre was retrospectively analysed. RESULTS: Thirty-four patients (22 women) were identified. Technical success was achieved in all cases. Adequate specimens for histological diagnosis were obtained in 25 (74%) cases. Overall, EUS-TTNB led to a change in management in 24 (71%) cases. Sixteen (47%) patients were downstaged, with 5 (15%) discharged from surveillance. Eight (24%) were upstaged, with 5 (15%) referred for surgical resection. In the 10 (29%) cases without change in management, 7 (21%) had confirmation of diagnosis with no change in surveillance, and 3 (9%) had insufficient biopsies on EUS-TTNB. Two (6%) patients developed post-procedural pancreatitis, and 1 (3%) developed peri-procedural intracystic bleeding with no subsequent clinical sequelae. CONCLUSION: EUS-TTNB permits histological confirmation of the nature of PCL, which can alter management outcomes. Care should be taken in patient selection and appropriately consented due to the adverse event rate.

Intraductal fully covered self-expanding metal stents in the management of post-liver transplant anastomotic strictures: a UK wide experience.

Background: Fully covered intraductal self-expanding metal stents (IDSEMS) have been well described in the management of post-liver transplant (LT) anastomotic strictures (ASs). Their antimigration waists and intraductal nature make them suited for deployment across the biliary anastomosis. Objectives: We conducted a multicentre study to analyse their use and efficacy in the management of AS. Design: This was a retrospective, multicentre observational study across nine tertiary centres in the United Kingdom. Methods: Consecutive patients who underwent endoscopic retrograde cholangiopancreatography with IDSEMS insertion were analysed retrospectively. Recorded variables included patient demographics, procedural characteristics, response to therapy and follow-up data. Results: In all, 162 patients (100 males, 62%) underwent 176 episodes of IDSEMS insertion for AS. Aetiology of liver disease in this cohort included hepatocellular carcinoma (n = 35, 22%), followed by alcohol-related liver disease (n = 29, 18%), non-alcoholic steatohepatitis (n = 20, 12%), primary biliary cholangitis (n = 15, 9%), acute liver failure (n = 13, 8%), viral hepatitis (n = 13, 8%) and autoimmune hepatitis (n = 12, 7%). Early AS occurred in 25 (15%) cases, delayed in 32 (20%) cases and late in 95 (59%) cases. Age at transplant was 54 years (range, 12-74), and stent duration was 15 weeks (range, 3 days-78 weeks). In total, 131 (81%) had complete resolution of stricture at endoscopic re-evaluation. Stricture recurrence was observed in 13 (10%) cases, with a median of 19 weeks (range, 4-88 weeks) after stent removal. At removal, there were 21 (12%) adverse events, 5 (3%) episodes of cholangitis and 2 (1%) of pancreatitis. In 11 (6%) cases, the removal wires unravelled, and 3 (2%) stents migrated. All were removed endoscopically. Conclusion: IDSEMS appears to be safe and highly efficacious in the management of post-LT AS, with low rates of AS recurrence.

Factors predicting 30-day mortality after ERCP in patients with inoperable malignant hilar biliary obstruction: a single tertiary referral centre experience and systematic review.

OBJECTIVE: There is a paucity of studies in the literature body evaluating short term outcomes following endoscopic retrograde cholangiopancreatography (ERCP) in patients with inoperable malignant hilar biliary obstruction (MHBO). We aimed to primarily evaluate 30-day mortality in these patients and secondarily, conduct a systematic review of studies reporting 30-day mortality. DESIGN: We conducted a retrospective analysis of all patients with inoperable MHBO who underwent ERCP at Leeds Teaching Hospitals NHS Trust between February 2015 and September 2020. Logistic regression models constructed from baseline patient data, the modified Glasgow Prognostic Score (mGPS) and Charlson Comorbidity Index (CCI) were evaluated as predictors of 30-day mortality. RESULTS: Eighty-seven patients (49 males) with a mean age of 70.4 years (SD ±12.3) were included. Cholangiocarcinoma was the most common aetiology of MHBO affecting 35/87 (40.2%). Technical success was achieved in 72/87 (82.8%). The 30-day mortality rate was 25.3% (22/87), of which 16 were due to progression of underlying malignant disease. On multivariate analysis, only leucocytosis (OR 4.12, 95% CI 2.70 to 7.41, p=0.02) was an independent predictor of 30-day mortality. Neither mGPS (p=0.47) nor CCI with a cut-off value of ≥7 (p=0.06) were significant predictors of 30-day mortality. CONCLUSION: We demonstrated that 30-day mortality following ERCP for inoperable MHBO remains high despite technical success. Further studies are warranted to identify patients most appropriate for intervention.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review.

1: ESGE recommends a prolonged course of a prophylactic broad-spectrum antibiotic in patients with ascites who are undergoing therapeutic endoscopic ultrasound (EUS) procedures.Strong recommendation, low quality evidence. 2: ESGE recommends placement of partially or fully covered self-expandable metal stents during EUS-guided hepaticogastrostomy for biliary drainage in malignant disease.Strong recommendation, moderate quality evidence. 3: ESGE recommends EUS-guided pancreatic duct (PD) drainage should only be performed in high volume expert centers, owing to the complexity of this technique and the high risk of adverse events.Strong recommendation, low quality evidence. 4: ESGE recommends a stepwise approach to EUS-guided PD drainage in patients with favorable anatomy, starting with rendezvous-assisted endoscopic retrograde pancreatography (RV-ERP), followed by antegrade or transmural drainage only when RV-ERP fails or is not feasible.Strong recommendation, low quality evidence. 5: ESGE suggests performing transduodenal EUS-guided gallbladder drainage with a lumen-apposing metal stent (LAMS), rather than using the transgastric route, as this may reduce the risk of stent dysfunction.Weak recommendation, low quality evidence. 6: ESGE recommends using saline instillation for small-bowel distension during EUS-guided gastroenterostomy.Strong recommendation, low quality evidence. 7: ESGE recommends the use of saline instillation with a 19G needle and an electrocautery-enhanced LAMS for EUS-directed transgastric endoscopic retrograde cholangiopancreatography (EDGE) procedures.Strong recommendation, low quality evidence. 8: ESGE recommends the use of either 15- or 20-mm LAMSs for EDGE, with a preference for 20-mm LAMSs when considering a same-session ERCP.Strong recommendation, low quality evidence.

Controversies in ERCP: Technical aspects.

The aim of the series of papers on controversies of biliopancreatic drainage procedures is to discuss pros and cons of the varying clinical practices and techniques in ERCP and EUS for drainage of biliary and pancreatic ducts. While the first part focuses on indications, clinical and imaging prerequisites prior to ERCP, sedation options, post-ERCP pancreatitis prophylaxis, and other related technical topics, the second part discusses specific procedural ERCP techniques including precut techniques and their timing as well as management algorithms. In addition, reviews on controversies in EUS-guided bile duct and pancreatic drainage procedures are under preparation.

Controversies in ERCP: Indications and preparation.

The aim of the series of papers on controversies of biliopancreatic drainage procedures is to discuss the pros and cons of the varying clinical practices and techniques in ERCP and EUS for drainage of biliary and pancreatic ducts. The first part focuses on indications, clinical and imaging prerequisites before ERCP, sedation options, post-ERCP pancreatitis (PEP) prophylaxis, and other related technical topics. In the second part, specific procedural ERCP-techniques including precut techniques and its timing as well as management algorithms are discussed. In addition, controversies in EUS-guided bile duct and pancreatic drainage procedures are under preparation.

Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

1: ESGE recommends the use of endoscopic ultrasound-guided biliary drainage (EUS-BD) over percutaneous transhepatic biliary drainage (PTBD) after failed endoscopic retrograde cholangiopancreatography (ERCP) in malignant distal biliary obstruction when local expertise is available.Strong recommendation, moderate quality evidence. 2: ESGE suggests EUS-BD with hepaticogastrostomy only for malignant inoperable hilar biliary obstruction with a dilated left hepatic duct when inadequately drained by ERCP and/or PTBD in high volume expert centers.Weak recommendation, moderate quality evidence. 3: ESGE recommends that EUS-guided pancreatic duct (PD) drainage should only be considered in symptomatic patients with an obstructed PD when retrograde endoscopic intervention fails or is not possible.Strong recommendation, low quality evidence. 4: ESGE recommends rendezvous EUS techniques over transmural PD drainage in patients with favorable anatomy owing to its lower rate of adverse events.Strong recommendation, low quality evidence. 5: ESGE recommends that, in patients at high surgical risk, EUS-guided gallbladder drainage (GBD) should be favored over percutaneous gallbladder drainage where both techniques are available, owing to the lower rates of adverse events and need for re-interventions in EUS-GBD.Strong recommendation, high quality of evidence. 6: ESGE recommends EUS-guided gastroenterostomy (EUS-GE), in an expert setting, for malignant gastric outlet obstruction, as an alternative to enteral stenting or surgery.Strong recommendation, low quality evidence. 7: ESGE recommends that EUS-GE may be considered in the management of afferent loop syndrome, especially in the setting of malignancy or in poor surgical candidates. Strong recommendation, low quality evidence. 8: ESGE suggests that endoscopic ultrasound-directed transgastric ERCP (EDGE) can be offered, in expert centers, to patients with a Roux-en-Y gastric bypass following multidisciplinary decision-making, with the aim of overcoming the invasiveness of laparoscopy-assisted ERCP and the limitations of enteroscopy-assisted ERCP.Weak recommendation, low quality evidence.

Esophageal stenting for benign and malignant disease: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021.

MALIGNANT DISEASE: 1: ESGE recommends placement of partially or fully covered self-expandable metal stents (SEMSs) for palliation of malignant dysphagia over laser therapy, photodynamic therapy, and esophageal bypass.Strong recommendation, high quality evidence. 2 : ESGE recommends brachytherapy as a valid alternative, alone or in addition to stenting, in esophageal cancer patients with malignant dysphagia and expected longer life expectancy.Strong recommendation, high quality evidence. 3: ESGE recommends esophageal SEMS placement for sealing malignant tracheoesophageal or bronchoesophageal fistulas. Strong recommendation, low quality evidence. 4 : ESGE does not recommend SEMS placement as a bridge to surgery or before preoperative chemoradiotherapy because it is associated with a high incidence of adverse events. Other options such as feeding tube placement are preferable. Strong recommendation, low quality evidence. BENIGN DISEASE: 5: ESGE recommends against the use of SEMSs as first-line therapy for the management of benign esophageal strictures because of the potential for adverse events, the availability of alternative therapies, and their cost. Strong recommendation, low quality evidence. 6: ESGE suggests consideration of temporary placement of self-expandable stents for refractory benign esophageal strictures. Weak recommendation, moderate quality evidence. 7: ESGE suggests that fully covered SEMSs be preferred over partially covered SEMSs for the treatment of refractory benign esophageal strictures because of their very low risk of embedment and ease of removability. Weak recommendation, low quality evidence. 8: ESGE recommends the stent-in-stent technique to remove partially covered SEMSs that are embedded in the esophageal wall. Strong recommendation, low quality evidence. 9: ESGE recommends that temporary stent placement can be considered for the treatment of leaks, fistulas, and perforations. No specific type of stent can be recommended, and the duration of stenting should be individualized. Strong recommendation, low quality of evidence. 10 : ESGE recommends considering placement of a fully covered large-diameter SEMS for the treatment of esophageal variceal bleeding refractory to medical, endoscopic, and/or radiological therapy, or as initial therapy for patients with massive bleeding. Strong recommendation, moderate quality evidence.

Upper gastrointestinal stenting during the SARS-CoV-2 outbreak: impact of mitigation measures and risk of contamination for patients and staff.

Background and study aims The impact of COVID-19 mitigation measures on stent placement procedures has not yet been reported. The aim of this study was to assess the impact of COVID-19 mitigation measures on upper stenting during SARS-CoV-2 outbreak, as well as the use of personal protection equipment (PPE) and risk of contamination for patients and staff. Patients and methods This was a multicenter, retrospective study of consecutive patients who underwent stent placement for upper gastrointestinal obstruction during the second half of SARS-CoV-2 outbreak period in comparison to same period one year before. Results A total of 29 stents were placed for upper gastrointestinal obstruction during the study period, corresponding to an increase of 241 % comparing to the same period in 2019 (n = 12). No significant major differences were found between the two time periods regarding patients' baseline characteristics, post-stenting management and number of staff involved in stent placement. Fellows' involvement was significantly lower in 2020 compared to 2019 (21 % vs 67 %; P  = 0.01). The majority of procedures were performed using FFP2 /FFP3 mask (76 %), protective eyewear (86 %), two pairs of gloves (65 %), hairnet (76 %) and full disposable gowns (90 %). One patient tested positive for SARS-CoV-2 after the procedure. None of the medical staff involved in stenting procedures developed COVID-19 14 days after procedure. Conclusion Upper gastrointestinal stenting increased during the SARS-CoV-2 outbreak period, which could be related to yearly variation on the number of procedures or reflect a change of oncologic treatment practice during COVID times.

Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020.

The following recommendations should only be applied after a thorough diagnostic evaluation including a contrast-enhanced computed tomography (CT) scan. 1 : ESGE recommends colonic stenting to be reserved for patients with clinical symptoms and radiological signs of malignant large-bowel obstruction, without signs of perforation. ESGE does not recommend prophylactic stent placement.Strong recommendation, low quality evidence. 2 : ESGE recommends stenting as a bridge to surgery to be discussed, within a shared decision-making process, as a treatment option in patients with potentially curable left-sided obstructing colon cancer as an alternative to emergency resection.Strong recommendation, high quality evidence. 3 : ESGE recommends colonic stenting as the preferred treatment for palliation of malignant colonic obstruction.Strong recommendation, high quality evidence. 4 : ESGE suggests consideration of colonic stenting for malignant obstruction of the proximal colon either as a bridge to surgery or in a palliative setting.Weak recommendation, low quality evidence. 5 : ESGE suggests a time interval of approximately 2 weeks until resection when colonic stenting is performed as a bridge to elective surgery in patients with curable left-sided colon cancer.Weak recommendation, low quality evidence. 6 : ESGE recommends that colonic stenting should be performed or directly supervised by an operator who can demonstrate competence in both colonoscopy and fluoroscopic techniques and who performs colonic stenting on a regular basis.Strong recommendation, low quality evidence. 7 : ESGE suggests that a decompressing stoma as a bridge to elective surgery is a valid option if the patient is not a candidate for colonic stenting or when stenting expertise is not available.Weak recommendation, low quality evidence.