Endoscopic ultrasound-guided gallbladder and bile duct drainage with lumen apposing metal stent: A large multicenter cohort (with videos).

BACKGROUND AND AIM: Cholecystectomy and endoscopic retrograde cholangiopancreatography are the gold standard for managing acute cholecystitis and malignant biliary obstruction, respectively. Recent advances in therapeutic endoscopic ultrasound (EUS) have provided alternatives for managing patients in whom these approaches fail, namely, EUS-guided gallbladder drainage (EUS-GB) and EUS-guided bile duct drainage (EUS-BD). We aimed to assess the technical and clinical success of these techniques in the largest multicenter cohort published to date. METHODS: A retrospective, multicenter, observational study involving 17 centers across Australia and New Zealand was conducted. All patients who had EUS-GB or EUS-BD performed in a participating center using a lumen apposing metal stent between 2016 and 2020 were included. Primary outcome was technical success, defined as intra-procedural successful drainage. Secondary outcomes included clinical success and 30-day mortality. RESULTS: One hundred and fifteen patients underwent EUS-GB (n = 49) or EUS-BD (n = 66). EUS-GB was technically successful in 47 (95.9%) while EUS-BD was successful in 60 (90.9%). All failed cases were due to maldeployment of the distal flange outside of the targeted lumen. Clinical success of EUS-GB was achieved in 39 (79.6%). No patients required subsequent cholecystectomy. Clinical success of EUS-BD was achieved in 52 (78.8 %). Thirty-day mortality was 14.3% for EUS-GB and 12.1% for EUS-BD. CONCLUSIONS: EUS-guided gallbladder drainage and EUS-BD are promising alternatives for managing nonsurgical candidates with cholecystitis and malignant biliary obstruction following failed endoscopic retrograde pancreatography. Both techniques delivered high technical success with acceptable clinical success. Further research is needed to investigate the gap between technical and clinical success.

Drainage of pancreatic fluid collections using a lumen-apposing metal stent with an electrocautery-enhanced delivery system.

BACKGROUND AND AIM: Our aim was to evaluate the efficacy and safety of a lumen-apposing metal stent with an electrocautery-enhanced delivery system (EDS-LAMS) for endoscopic ultrasound (EUS)-guided drainage of pancreatic fluid collections (PFCs) in regular clinical practice. METHODS: A retrospective and subsequent prospective analysis was undertaken of all patients who underwent EUS-guided drainage of their PFCs using the EDS-LAMS at 17 tertiary therapeutic endoscopy centers. RESULTS: Two hundred eight cases of EDS-LAMS deployment were attempted in 202 patients (mean age 52.9 years) at time of evaluation. Ninety-seven patients had pancreatic pseudocysts (PPs), 75 walled-off pancreatic necrosis (WOPN), 10 acute peripancreatic fluid collections (APFCs), 6 acute necrotic collections (ANCs), and 14 postoperative collections (POCs). Procedural technical success was achieved in 202/208 cases (97.1%). Maldeployment occurred in 7/208 cases (3.4%). Clinical success was achieved in 142/160 (88.8%) patients (PP 90%, WOPN 85.2%, APFC 100%, ANC 75%, POC 100%). Delayed adverse events included stent migration in 15/202 (7.4%), stent occlusion and infection in 16/202 (7.9%), major bleeding in 4/202 (2%), and buried EDS-LAMS in 2/202 (1%). PFC recurrence occurred in 13/142 (9.2%) patients; 9/202 (4.5%) required surgical or radiological intervention for PFC management after EDS-LAMS insertion. CONCLUSIONS: This large international multicenter study evaluating the EDS-LAMS for drainage of PFCs in routine clinical practice suggests that the EDS-LAMS are safe and effective for drainage of all types of PFCs; however, further endoscopic therapy is often required for WOPN. Major bleeding was a rare complication in our cohort.

Monitoring quality of care for patients with pancreatic cancer: a modified Delphi consensus.

BACKGROUND: Best practise care optimises survival and quality of life in patients with pancreatic cancer (PC), but there is evidence of variability in management and suboptimal care for some patients. Monitoring practise is necessary to underpin improvement initiatives. We aimed to develop a core set of quality indicators that measure quality of care across the disease trajectory. METHODS: A modified, three-round Delphi survey was performed among experts with wide experience in PC care across three states in Australia. A total of 107 potential quality indicators were identified from the literature and divided into five areas: diagnosis and staging, surgery, other treatment, patient management and outcomes. A further six indicators were added by the panel, increasing potential quality indicators to 113. Rated on a scale of 1-9, indicators with high median importance and feasibility (score 7-9) and low disagreement (<1) were considered in the candidate set. RESULTS: From 113 potential quality indicators, 34 indicators met the inclusion criteria and 27 (7 diagnosis and staging, 5 surgical, 4 other treatment, 5 patient management, 6 outcome) were included in the final set. CONCLUSIONS: The developed indicator set can be applied as a tool for internal quality improvement, comparative quality reporting, public reporting and research in PC care.

Management of pancreatic collections with a novel endoscopically placed fully covered self-expandable metal stent: a national experience (with videos).

BACKGROUND: Recent medical literature on novel lumen-apposing stents for the treatment of pancreatic fluid collections (PFCs) is limited by small numbers, solo operators, and single-center experience. OBJECTIVE: To evaluate a recently developed lumen-apposing, fully covered self-expandable metal stent (FCSEMS) in the management of PFCs. DESIGN: Retrospective case series. SETTING: Thirteen tertiary and private health care centers across Australia. PATIENTS: Forty-seven patients (median age 51 years) who underwent endoscopic management of PFCs. INTERVENTION: Insertion of FCSEMS after PFC puncture under EUS guidance. A subgroup of 9 patients underwent direct endoscopic necrosectomy. MAIN OUTCOME MEASUREMENTS: Technical and clinical success rate, adverse event rate. RESULTS: The technical success rate was 53 of 54 patients (98.1%), and the initial clinical success rate was 36 of 47 (76.6%), which was sustained for more than 6 months in 34 of 36 (94.4%). Early adverse events included 4 cases (7.4%) of stent migration during direct endoscopic necrosectomy, 4 cases (7.4%) of sepsis, 1 case (1.9%) of bleeding, and 1 case (1.9%) of stent migration into the fistula tract. Late adverse events were 6 (11.1%) spontaneous stent migrations, 3 (5.6%) recurrent stent occlusions, 3 (5.6%) tissue ingrowth/overgrowth, and 2 (3.7%) bleeding into PFC. The majority of stents inserted (48 of 54, 88.9%) and removed (31 of 35, 88.6%) in our study were described by the operator as superior to pigtail stents with regard to ease of use. LIMITATIONS: Retrospective study. CONCLUSION: Although FCSEMSs are technically easier to insert and remove compared with traditional pigtail stents, there are significant limitations to the widespread use of FCSEMSs in the management of PFCs. These include cost, adverse events, and lower-than-expected resolution rates.

Role of CT angiography and therapeutic anticoagulation in patients presenting to the emergency department with acute gastrointestinal bleeding.

INTRODUCTION: Acute gastrointestinal bleeding (GIB) is associated with morbidity and mortality. There can be a low threshold for practitioners to assess for active GIB and computed tomography angiography (CTA) examinations are performed frequently, even for stable patients and those who are therapeutically anticoagulated. We aimed to assess the predictive value of CTA for acute GIB and the influence of CTA on treatment. METHODS: Retrospective single-centre study over a 2-year period. RESULTS: A total of 227 patients with mean age 67.7 years (SD 17.86), 58.6% male. 84.4% were for lower GIB. 49 patients were on therapeutic anticoagulation (21.6%). 45 CTAs were positive (19.8%). 22 patients received embolisation, and 15 received acute endoscopic treatment. CTA sensitivity was 68.6% and specificity 89.1%. The PPV was 53.3% and NPV 93.9%. The odds ratio of a positive CTA requiring treatment for patients on therapeutic anticoagulation was 1.1 (P = 0.932) compared with the odds of patients not taking therapeutic anticoagulation 21.5 (P < 0.001). The risk ratio for requiring treatment if not taking anticoagulation was 6.2. A total of 19 patients (9.1%) met the definition of CI-AKI as a result of the CTA. A pre-existing eGFR of less than 20 was associated with significantly increased odds of developing CI-AKI (OR 3.95, P = 0.031, 95%CI 1.135-13.782). CONCLUSIONS: The presence of anticoagulation has a significant impact on the decision not to perform interventional treatments on patients with acute GIB when CTA is positive. Anticoagulant reversal and volume resuscitation are important front-line measures, and CTA may have a role for those anticoagulated who are haemodynamically unstable after resuscitation.

Management of bile leak following blunt liver injury: a proposed guideline.

BACKGROUND: Bile leak following blunt liver trauma is uncommon. Management is difficult due to complex vasculo-biliary and liver parenchymal injury and lack of consensus on optimal care compared with bile leak following elective hepatectomy especially in regards to endoscopic retrograde pancreaticocholangiography (ERCP) timing and patient selection. METHODS: This is a retrospective cohort study from a level 1-trauma centre of patients with bile leak following blunt liver injury between July 2010 and December 2019 identified from the trauma registry. Clinical data retrieved include patient demographics, injury severity score, liver injury grading and its associated complications and treatment. This was supplemented by surgical audit database and patients' electronic medical record. RESULTS: There were 31 bile leaks amongst 639 patients with blunt liver trauma (4.9%). Bile leak was associated with higher liver injury grade (odds ratio (OR) 36, P = 0.001), hepatic embolization (OR 16, P = 0.003) and need for trauma laparotomy (OR 14, P = 0.024). ERCP was performed in 58.1% (n = 18). This was complicated in 27.7% (n = 5) by mild pancreatitis (n = 1) and intra-abdominal sepsis (n = 4) requiring surgical drainage of abscess (n = 2) and liver resection (n = 1). Bile leak settled conservatively (including percutaneous drainage) without ERCP in the remaining patients (41.9%). Overall mortality was not increased in those with bile leak (P = 0.998). CONCLUSION: Bile leaks resolved conservatively in 41.9% of patients. Complications following ERCP were seen in 27.7%, frequently requiring intervention. Failure of conservative management was more likely in patients with hepatic embolization, in whom early ERCP remains appropriate. ERCP should otherwise be reserved for those who fail conservative management to minimize infective complications.

The EUS molecular evaluation of pancreatic cancer: A prospective multicenter cohort trial.

BACKGROUND AND OBJECTIVES: Patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (A-PDAC) are not candidates for surgical resection and are often offered palliative chemotherapy. The ready availability of a safe and effective tumor sampling technique to provide material for both diagnosis and comprehensive genetic profiling is critical for informing precision medicine in A-PDAC, thus potentially increasing survival. The aim of this study is to examine the feasibility and benefits of routine comprehensive genomic profiling (CGP) of A-PDAC using EUS-FNA material. METHODS: This is a prospective cohort study to test the clinical utility of fresh frozen or archival EUS-FNA samples in providing genetic material for CGP. The results of the CGP will be reviewed at a molecular tumor board. The proportion of participants that have a change in their treatment recommendations based on their individual genomic profiling will be assessed. Correlations between CGP and stage, prognosis, response to treatment and overall survival will also be investigated. This study will open to recruitment in 2020, with a target accrual of 150 A-PDAC patients within 36 months, with a 2-year follow-up. It is expected that the majority of participants will be those who have already consented for their tissue to be biobanked in the Victorian Pancreatic Cancer Biobank at the time of diagnostic EUS-FNA. Patients without archival or biobanked material that is suitable for CGP may be offered a EUS-FNA procedure for the purposes of obtaining fresh frozen material. DISCUSSION: This trial is expected to provide crucial data regarding the feasibility of routine CGP of A-PDAC using EUS-FNA material. It will also provide important information about the impact of this methodology on patients' survival.

The Upper Gastrointestinal Cancer Registry (UGICR): a clinical quality registry to monitor and improve care in upper gastrointestinal cancers.

PURPOSE: The Upper Gastrointestinal Cancer Registry (UGICR) was developed to monitor and improve the quality of care provided to patients with upper gastrointestinal cancers in Australia. PARTICIPANTS: It supports four cancer modules: pancreatic, oesophagogastric, biliary and primary liver cancer. The pancreatic cancer (PC) module was the first module to be implemented, with others being established in a staged approach. Individuals are recruited to the registry if they are aged 18 years or older, have received care for their cancer at a participating public/private hospital or private clinic in Australia and do not opt out of participation. FINDINGS TO DATE: The UGICR is governed by a multidisciplinary steering committee that provides clinical governance and oversees clinical working parties. The role of the working parties is to develop quality indicators based on best practice for each registry module, develop the minimum datasets and provide guidance in analysing and reporting of results. Data are captured from existing data sources (population-based cancer incidence registries, pathology databases and hospital-coded data) and manually from clinical records. Data collectors directly enter information into a secure web-based Research Electronic Data Capture (REDCap) data collection platform. The PC module began with a pilot phase, and subsequently, we used a formal modified Delphi consensus process to establish a core set of quality indicators for PC. The second module developed was the oesophagogastric cancer (OGC) module. Results of the 1 year pilot phases for PC and OGC modules are included in this cohort profile. FUTURE PLANS: The UGICR will provide regular reports of risk-adjusted, benchmarked performance on a range of quality indicators that will highlight variations in care and clinical outcomes at a health service level. The registry has also been developed with the view to collect patient-reported outcomes (PROs), which will further add to our understanding of the care of patients with these cancers.

Microscopic colitis demonstrates a T helper cell type 1 mucosal cytokine profile.

BACKGROUND: Microscopic colitis (MC) is an inflammatory disorder of unknown aetiology. AIM: To characterise the mucosal cytokine profile of MC, with a view to understanding its potential pathogenic mechanisms. METHODS: Cytokine profiles of mucosal biopse specimens taken at flexible sigmoidoscopy from 18 patients (8 with lymphocytic colitis and 10 with collagenous colitis) were analysed using real-time reverse transcriptase-PCR, in comparison with those from 13 aged-matched controls with diarrhoea-predominant irritable bowel syndrome. Biopsy specimens from six patients with histologically documented remission were available for comparative analysis. Biopsy specimens were also taken to determine the cellular expression of cytokine and cytokine-related proteins using immunohistochemistry. RESULTS: Mucosal mRNA levels were 100 times greater for interferon (IFN)gamma and interleukin (IL) 15, 60 times greater for tumour necrosis factor alpha, and 35 times greater for inducible nitric oxide synthase in MC compared with controls. Apart from a trend for increased levels of IL10, levels of other T helper cell type 2 (T(H)2) cytokines including IL2 and IL4 were too low to be accurately quantified. Mucosal IFNgamma mRNA levels correlated with the degree of diarrhoea, and returned to normal in remission. The immunohistochemical expression of cell junction proteins E-cadherin and ZO-1 was reduced in active disease. No differences were noted between lymphocytic and collagenous colitis for any of the above parameters. CONCLUSIONS: MC demonstrates a T(H)1 mucosal cytokine profile with IFNgamma as the predominantly upregulated cytokine, with concurrent induction of nitric oxide synthase and down regulation of IFNgamma-related cell junction proteins. This pattern is similar to that in coeliac disease and suggests that it might represent a response to a luminal antigen.

Selective colonization by Helicobacter pylori of the deep gastric glands and intracellular canaliculi of parietal cells in the setting of chronic proton pump inhibitor use.

Colonization by Helicobacter pylori of the acid-secreting tubules of gastric glands and the canaliculi of parietal cells has only rarely been reported. The presence of these organisms in such "deep" locations has only been reported in association with the more typical superficial colonization of the mucous gel layer overlying gastric epithelial cells. We report two cases of deep H. pylori infection without the presence of superficial organisms. Both patients had been using proton pump inhibitors for many years. We review the literature regarding the distribution of H. pylori within the stomach and the effect of proton pump inhibitor use on H. pylori distribution.

Catching a chameleon: IgG4-related systemic disease.

IgG4-related systemic disease (IRSD) is a recently described entity with protean manifestations. We describe a patient who developed inflammation and fibrosis in multiple organs over 20 years, sequentially involving his pancreas, bile ducts, gallbladder, submandibular and lacrimal glands, and kidneys. He had an elevated serum IgG4 level. Retrospective analysis of biopsies showed strongly positive tissue immunostaining for IgG4, confirming the diagnosis of IRSD. This case illustrates the natural history of partially treated IRSD and its varied clinical presentations. Early diagnosis and treatment is important, as the condition is highly steroid-responsive.

Oral sodium phosphate (Fleet) is a superior colonoscopy preparation to Picopre (sodium picosulfate-based preparation).

PURPOSE: Small-volume bowel preparation is better tolerated than 4-liter polyethylene glycol lavage. However, the efficacy of various small-volume bowel preparation agents for colonoscopy has not been clearly defined. This randomized, controlled trial was designed to compare oral sodium phosphate (Fleet) with Picoprep (sodium picosulfate-based preparation). METHODS: Two hundred twenty-five outpatients, aged 65 years or younger, who would undergo colonoscopy by two endoscopists were randomized to receive two bottles of oral sodium phosphate or three sachets of Picoprep. A standardized questionnaire was completed by all patients and the endoscopists. The endoscopists were blinded to the preparation used. RESULTS: One hundred three patients were randomized to oral sodium phosphate (Fleet) (Group 1) and 122 patients to Picoprep (Group 2). Three patients were excluded because of colonic strictures. The groups were similar in age and gender, indications for colonoscopy, and previous colonic surgery. The quality of bowel cleansing in patients taking oral sodium phosphate (Fleet) was significantly better than Picoprep as assessed by the endoscopists (P = 0.0014). Both types of bowel preparation were associated with similar incidence of nausea (P = 0.4927), dizziness (P= 0.9663), abdominal cramps (P = 0.7157), and patient acceptability (P = 0.0767). Equal majority from either group would use the same bowel preparation again (91 percent of oral sodium phosphate (Fleet) and 93 percent of Picoprep group; P = 0.6172). Although Picoprep was better tasting (P = 0.0273), oral sodium phosphate (Fleet)was perceived to be a good preparation agent by a greater (although not significant) proportion of patients (P = 0.0853). CONCLUSIONS: Oral sodium phosphate (Fleet) is more effective in bowel cleansing than Picoprep as a bowel preparation agent. Both agents have similar side effects and patient acceptance.

Microscopic colitis.

Microscopic colitis is an umbrella term used to include two idiopathic inflammatory bowel disorders that present with chronic watery diarrhea, normal endoscopic findings and characteristic inflammatory changes on histology. Collagenous colitis and lymphocytic colitis are distinguished by the presence of a thickened subepithelial collagen table. It is likely that they are a spectrum of one disease, but this is yet to be proven. The majority of cases tend to undergo spontaneous remission within a few years of onset, and their clinical course is benign, with no increase in risk of colorectal cancer. Sufficient evidence exists to suggest that microscopic colitis occurs as a response to one or more luminal antigens. A variety of medications have been reported in the treatment of this condition, but only colloidal bismuth and budesonide have thus far been shown to be effective in randomized controlled trials.

Carbohydrate-electrolyte (E-Lyte) solution enhances bowel preparation with oral fleet phospho-soda.

PURPOSE: Bowel preparation with oral sodium phosphate can cause symptomatic dehydration and electrolyte disturbances. This randomized, controlled trial was designed to evaluate whether carbohydrate-electrolyte (E-Lyte) solution enhanced bowel preparation and improved patient acceptance with oral sodium phosphate. METHODS: A total of 187 consecutive adults undergoing colonoscopy by two endoscopists were randomized to receive two packets of oral sodium phosphate (Fleet Phospho-soda) with or without additional supplement of a carbohydrate-electrolyte (E-Lyte) solution. All patients and endoscopists completed a standardized questionnaire. Urine-specific gravity and serum biochemistry were randomly performed in 150 and 50 patients, respectively. RESULTS: Ninety patients were randomized to have oral sodium phosphate with E-Lyte supplements (Group 1) and 94 patients to sodium phosphate without E-Lyte supplements (Group 2). The groups were similar in age and gender, indication for colonoscopy, and previous colonic surgery. Patients taking E-Lyte supplement had significantly less dizziness (none, 80 vs. 56 percent; P < 0.001) and a trend toward less nausea (none, 70 vs. 56 percent; P = 0.05). All patients in Group 1 completed the bowel preparation as opposed to 3 percent of Group 2 being unable to complete the preparation. Hypokalemia was significantly more frequent ( P = 0.008) in Group 2 patients without E-Lyte supplements. More patients in Group 2 needed intravenous rehydration (11 vs. 4 percent). Differences in serum creatinine and urine-specific gravity suggested possibly a lesser degree of hypovolemia in patients taking E-Lyte supplements. The quality of bowel cleansing in patients taking E-Lyte supplements was considered better by both the endoscopists and patients. CONCLUSIONS: Carbohydrate-electrolyte (E-Lyte) solution protects against hypokalemia, improves patient tolerability, and may enhance use of oral sodium phosphate as a bowel-preparation agent.