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.

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.

The Glasgow Prognostic Score at the Time of Palliative Esophageal Stent Insertion is a Predictive Factor of 30-Day Mortality and Overall Survival.

BACKGROUND: Optimizing the timing of esophageal stent insertion is a challenge, partly due to difficulty predicting survival in advanced malignancy. The Glasgow prognostic score (GPS) is a validated tool for predicting survival in a number of cancers. GOALS: To assess the utility of the GPS in predicting 30-day mortality and overall survival postesophageal stent insertion. STUDY: Patients at a tertiary referral center who had received an esophageal stent for palliation of dysphagia were included if they had a measurement of albumin and C-reactive protein (CRP) in the week preceding the procedure (n=209). Patients with both an elevated CRP (>10 mg/L) and hypoalbuminemia (<35 g/L) were given a GPS score of 2 (GPS2). Patients with only one of these abnormalities were assigned as GPS1 and those with normal CRP and albumin were assigned as GPS0. Clinical and pathologic parameters were also collected to assess for potential confounding factors in the survival analysis. RESULTS: Increasing GPS was associated with 30-day mortality; for patients with GPS0, 30-day mortality was 5% (2/43), for GPS1 it was 23% (26/114), and for GPS2 it was 33% (17/52). The adjusted hazard ratio for overall poststent mortality was 1.6 (95% confidence interval, 1.1-2.4; P=0.02) for GPS1 and 2.4 (95% confidence interval, 1.5-3.8; P<0.001) for GPS2 patients compared with GPS0. CONCLUSIONS: GPS is an independent prognostic factor of 30-day mortality and overall survival after esophageal stent insertion. It is a potential adjunct to clinical assessment in identifying those patients at high-risk of short-term mortality poststent.

Guideline for obtaining valid consent for gastrointestinal endoscopy procedures.

Much has changed since the last guideline of 2008, both in endoscopy and in the practice of obtaining informed consent, and it is vital that all endoscopists who are responsible for performing invasive and increasingly risky procedures are aware of the requirements for obtaining valid consent. This guideline is restricted to GI endoscopy but we cover elective and acute or emergency procedures. Few clinical trials have been carried out in relation to informed consent but most areas are informed by guidance from the General Medical Counsel (GMC) and/or are enshrined in legislation. Following an iterative voting process a series of recommendations have been drawn up that cover the majority of situations that will be encountered by endoscopists. This is not exhaustive and where doubt exists we have described where legal advice is likely to be required. This document relates to the law and endoscopy practice in the UK-where there is variation between the four devolved countries this is pointed out and endoscopists must be aware of the law where they practice. The recommendations are divided into consent for patients with and without capacity and we provide sections on provision of information and the consent process for patients in a variety of situations. This guideline is intended for use by all practitioners who request or perform GI endoscopy, or are involved in the pathway of such patients. If followed, we hope this document will enhance the experience of patients attending for endoscopy in UK units.

Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial.

BACKGROUND: Transfusion thresholds for acute upper gastrointestinal bleeding are controversial. So far, only three small, underpowered studies and one single-centre trial have been done. Findings from the single-centre trial showed reduced mortality with restrictive red blood cell (RBC) transfusion. We aimed to assess whether a multicentre, cluster randomised trial is a feasible method to substantiate or refute this finding. METHODS: In this pragmatic, open-label, cluster randomised feasibility trial, done in six university hospitals in the UK, we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding, irrespective of comorbidity, except for exsanguinating haemorrhage. We randomly assigned hospitals (1:1) with a computer-generated randomisation sequence (random permuted block size of 6, without stratification or matching) to either a restrictive (transfusion when haemoglobin concentration fell below 80 g/L) or liberal (transfusion when haemoglobin concentration fell below 100 g/L) RBC transfusion policy. Neither patients nor investigators were masked to treatment allocation. Feasibility outcomes were recruitment rate, protocol adherence, haemoglobin concentration, RBC exposure, selection bias, and information to guide design and economic evaluation of the phase 3 trial. Main exploratory clinical outcomes were further bleeding and mortality at day 28. We did analyses on all enrolled patients for whom an outcome was available. This trial is registered, ISRCTN85757829 and NCT02105532. FINDINGS: Between Sept 3, 2012, and March 1, 2013, we enrolled 936 patients across six hospitals (403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy). Recruitment rate was significantly higher for the liberal than for the restrictive policy (62% vs 55%; p=0·04). Despite some baseline imbalances, Rockall and Blatchford risk scores were identical between policies. Protocol adherence was 96% (SD 10) in the restrictive policy vs 83% (25) in the liberal policy (difference 14%; 95% CI 7-21; p=0·005). Mean last recorded haemoglobin concentration was 116 (SD 24) g/L for patients on the restrictive policy and 118 (20) g/L for those on the liberal policy (difference -2·0 [95% CI -12·0 to 7·0]; p=0·50). Fewer patients received RBCs on the restrictive policy than on the liberal policy (restrictive policy 133 [33%] vs liberal policy 247 [46%]; difference -12% [95% CI -35 to 11]; p=0·23), with fewer RBC units transfused (mean 1·2 [SD 2·1] vs 1·9 [2·8]; difference -0·7 [-1·6 to 0·3]; p=0·12), although these differences were not significant. We noted no significant difference in clinical outcomes. INTERPRETATION: A cluster randomised design led to rapid recruitment, high protocol adherence, separation in degree of anaemia between groups, and non-significant reduction in RBC transfusion in the restrictive policy. A large cluster randomised trial to assess the effectiveness of transfusion strategies for acute upper gastrointestinal bleeding is both feasible and essential before clinical practice guidelines change to recommend restrictive transfusion for all patients with acute upper gastrointestinal bleeding. FUNDING: NHS Blood and Transplant Research and Development.

Development and validation of a scoring system to identify patients with microscopic colitis.

BACKGROUND & AIMS: Diarrhea is a common indication for colonoscopy. Biopsies are collected and analyzed from patients with a macroscopically normal colon to exclude microscopic colitis (MC), but the diagnostic yield is low because most patients have functional disease. We developed and validated a diagnostic scoring system to identify patients with MC to reduce the need to collect biopsies from all patients. METHODS: We performed a retrospective study, which analyzed demographic and symptom data from adult patients with chronic diarrhea evaluated by colonoscopy and biopsy at 3 endoscopy centers in Leeds, United Kingdom. To derive the scoring system, we analyzed data from 476 adult patients (mean age, 53.6 years; 63.7% female) examined in 2011. Factors significantly associated with the presence of MC were assigned item scores, and total scores were determined for each patient. To validate the system, we used it to assess data from 460 patients (mean age, 52.9 years; 59.8% female) examined in 2012. The primary aim of the study was to determine the performance of the diagnostic scoring system in identifying patients with MC by using histologic findings as a reference. RESULTS: In the derivation cohort, 85 patients were diagnosed with MC on the basis of histologic analysis. Age ≥50 years, female sex, use of proton pump inhibitors or nonsteroidal anti-inflammatory drugs, weight loss, and absence of abdominal pain were significantly associated with MC. We created a scoring system for diagnosis of MC, with scores ranging from -8 to +38; scores ≥8 were used to identify the presence of MC. This cutoff value identified patients with MC in the validation cohort (74 patients, 16.1%) with 90.5% sensitivity and 45.3% specificity (area under the receiver operating characteristic curve value, 0.76). Because of its ability to exclude MC and therefore avoid the need for routine collection of colonic biopsies, this scoring system reduced the cost of evaluation by >£7000 in the cohort. CONCLUSIONS: We collected data on risk factors for MC to create a scoring system that identifies patients with MC with more than 90% sensitivity. This system can also reduce costs by identifying patients who are unlikely to have MC who do not require biopsy analysis.

Comments and illustrations of the European Federation of Societies for Ultrasound in Medicine guidelines: Rare pancreatic tumors, ultrasound and contrast-enhanced ultrasound features-Malignant mesenchymal tumors.

Rare malignant mesenchymal pancreatic tumors are systematized and reported in this review. The focus is on the appearance on imaging. The present overview summarizes the data and shows that not every pancreatic tumor corresponds to the most common entities of ductal adenocarcinoma or neuroendocrine tumor.

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.

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.

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.

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.

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.

WITHDRAWN: Interventions for dysphagia in oesophageal cancer.

BACKGROUND: The majority of oesophageal and gastro-oesophageal cancers are diagnosed at an advanced stage and palliative treatment is the realistic management option for most patients. The optimal intervention for the palliation of dysphagia in these patients has not been established. OBJECTIVES: To systematically analyse and summarise the efficacy of different interventions used in the palliation of dysphagia in primary oesophageal carcinoma. SEARCH STRATEGY: We undertook a search according to the Cochrane Upper Gastrointestinal and Pancreatic Diseases model using the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE and CINAHL and major conference proceedings up to August 2005. The literature search was re-run in August 2006 and March 2007. SELECTION CRITERIA: Randomised controlled trials (RCTs) in patients with inoperable or unresectable primary oesophageal cancer who underwent palliative treatment. We included rigid plastic intubation, self-expanding metallic stent (SEMS) insertion, brachytherapy, external beam radiotherapy, chemotherapy, oesophageal bypass surgery, chemical and thermal ablation therapy, either head-to-head or in combination. The primary outcome was dysphagia improvement. Secondary outcomes included recurrent dysphagia, technical success, procedure related mortality, 30-day mortality, adverse effects and quality of life. DATA COLLECTION AND ANALYSIS: One author assessed the eligibility criteria of each study and extracted data regarding outcomes and factors affecting risk of bias. MAIN RESULTS: We included 2542 patients from 40 studies. SEMS insertion is safer and more effective than plastic tube insertion. Thermal and chemical ablative therapy provide comparable dysphagia palliation but have an increased requirement for re-interventions and adverse effects. Anti-reflux stents provide comparable dysphagia palliation to conventional metal stents. Some anti-reflux stents might reduce gastro-oesophageal reflux compared to conventional metal stents. Brachytherapy might be a suitable alternative to SEMS in providing a survival advantage and possibly a better quality of life. AUTHORS' CONCLUSIONS: Self-expanding metal stent insertion is safe, effective and quicker in palliating dysphagia compared to other modalities. However, high-dose intraluminal brachytherapy is a suitable alternative and might provide additional survival benefit with a better quality of life. Self-expanding metal stent insertion and brachytherapy provide comparable palliation to endoscopic ablative therapy but are preferable due to the reduced requirement for re-interventions. Rigid plastic tube insertion, dilatation alone or in combination with other modalities, chemotherapy alone, combination chemoradiotherapy and bypass surgery are not recommended for palliation of dysphagia due to a high incidence of delayed complications and recurrent dysphagia.

A study of indefinite for dysplasia in Barrett's oesophagus: reproducibility of diagnosis, clinical outcomes and predicting progression with AMACR (alpha-methylacyl-CoA-racemase).

AIMS: To assess interobserver variation in the diagnosis of dysplasia in Barrett's oesophagus, especially indefinite dysplasia (IND) using the revised Vienna classification. A secondary aim was to study clinical outcome of IND cases and to evaluate expression of alpha-methyl-CoA racemase (AMACR) as a marker predictive of progression. METHODS AND RESULTS: Cases of Barrett's oesophagus and dysplasia over a 20 year period were assessed. Three experienced histopathologists reviewed 101 cases on set criteria in a blinded fashion. Slides were immunostained for AMACR and evaluated for the presence, extent and location of AMACR expression. Clinical and progression data were collected. Overall agreement for the diagnosis of dysplasia was fair (k = 0.35) but that for IND was poor (k = 0.18). 6 IND cases progressed after a median follow-up of 31.4 months to a higher grade. The sensitivity of AMACR for the detection of abnormality was 22% for IND and specificity 100%. The positive predictive value of AMACR for progression was 0.44 and the negative predictive value was 0.92. CONCLUSION: Fair agreement was achieved for the diagnosis of dysplasia but poor agreement for IND. A proportion of IND cases progress. Re-diagnosis or consensus diagnosis did not predict progression. AMACR shows promise as a marker to indicate IND patients in need of more intensive surveillance.

Interventions for dysphagia in oesophageal cancer.

BACKGROUND: The majority of oesophageal and gastro-oesophageal cancers are diagnosed at an advanced stage and palliative treatment is the realistic management option for most patients. The optimal intervention for the palliation of dysphagia in these patients has not been established. OBJECTIVES: To systematically analyse and summarise the efficacy of different interventions used in the palliation of dysphagia in primary oesophageal carcinoma. SEARCH STRATEGY: We undertook a search according to the Cochrane Upper Gastrointestinal and Pancreatic Diseases model using the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE and CINAHL and major conference proceedings up to August 2005. The literature search was re-run in August 2006 and March 2007. SELECTION CRITERIA: Randomised controlled trials (RCTs) in patients with inoperable or unresectable primary oesophageal cancer who underwent palliative treatment. We included rigid plastic intubation, self-expanding metallic stent (SEMS) insertion, brachytherapy, external beam radiotherapy, chemotherapy, oesophageal bypass surgery, chemical and thermal ablation therapy, either head-to-head or in combination. The primary outcome was dysphagia improvement. Secondary outcomes included recurrent dysphagia, technical success, procedure related mortality, 30-day mortality, adverse effects and quality of life. DATA COLLECTION AND ANALYSIS: One author assessed the eligibility criteria of each study and extracted data regarding outcomes and factors affecting risk of bias. MAIN RESULTS: We included 2542 patients from 40 studies. SEMS insertion is safer and more effective than plastic tube insertion. Thermal and chemical ablative therapy provide comparable dysphagia palliation but have an increased requirement for re-interventions and adverse effects. Anti-reflux stents provide comparable dysphagia palliation to conventional metal stents. Some anti-reflux stents might reduce gastro-oesophageal reflux compared to conventional metal stents. Brachytherapy might be a suitable alternative to SEMS in providing a survival advantage and possibly a better quality of life. AUTHORS' CONCLUSIONS: Self-expanding metal stent insertion is safe, effective and quicker in palliating dysphagia compared to other modalities. However, high-dose intraluminal brachytherapy is a suitable alternative and might provide additional survival benefit with a better quality of life. Self-expanding metal stent insertion and brachytherapy provide comparable palliation to endoscopic ablative therapy but are preferable due to the reduced requirement for re-interventions. Rigid plastic tube insertion, dilatation alone or in combination with other modalities, chemotherapy alone, combination chemoradiotherapy and bypass surgery are not recommended for palliation of dysphagia due to a high incidence of delayed complications and recurrent dysphagia.

Endoscopic management of refractory benign oesophageal strictures.

Refractory benign oesophageal strictures are an infrequent presentation but a cause of significant morbidity and mortality. The treatment of these strictures has changed little in recent years, yet new evidence is emerging for the optimal timing and application of different therapies. In this article, we have carefully reviewed the current literature on the evaluation and management of refractory strictures and provided practical advice as to their management. A number of areas require attention in future research, including carefully designed randomised trials of endoscopic and medical therapies, and a focus on risk factors at a patient and molecular level to facilitate development of medical therapies that can reduce recurrent fibrosis in these patients.

Management of benign oesophageal strictures.

Benign oesophageal strictures are an important gastrointestinal condition that can cause substantial morbidity. There are many different aetiologies and each case needs careful evaluation and individualised treatment. Management usually involves targeting therapy to the underlying cause, but oesophageal dilatation is an important part of the algorithm. The recent British Society of Gastroenterology guidelines provide advice on the use of dilatation for benign strictures and cover patient preparation, the dilatation procedure and disease-specific considerations. This article provides a summary of the key messages from the guidelines and applies them to routine clinical practice. It also includes practical advice on the clinical assessment, investigation and management of benign oesophageal strictures and gives an approach to the management of refractory strictures. Areas where evidence is sparse and further research is needed are highlighted.