Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk. OBJECTIVE: To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement. DESIGN: This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up. RESULTS: Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality. CONCLUSION: This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement. TRIAL REGISTRATION NUMBER: NL5130.

Antibiotic Therapy of 3 Days May Be Sufficient After Biliary Drainage for Acute Cholangitis: A Systematic Review.

BACKGROUND: The optimal antibiotic therapy duration for cholangitis is unclear. Guideline recommendations vary between 4 and 14 days after biliary drainage. Clinical observations and some evidence however suggest that shorter antibiotic therapy may be sufficient. OBJECTIVE: To compare the effectiveness and safety of short-course therapy of ≤ 3 days with long-course therapy of ≥ 4 days after biliary drainage in cholangitis patients. METHODS: We searched the databases PubMed, EMBASE, Cochrane Library, and trial registers for literature up to August 5, 2020. RCTs and observational studies including case series reporting on antibiotic therapy duration for acute cholangitis were eligible for inclusion. Two reviewers independently evaluated study eligibility, extracted data, assessed risk of bias and quality of evidence. A meta-analysis was planned if the included studies were comparable with regard to important study characteristics. Primary outcomes included recurrent cholangitis, subsequent other infection, and mortality. RESULTS: We included eight studies with 938 cholangitis patients. Four observational studies enrolled patients treated for ≤ 3 days. Recurrent cholangitis occurred in 0-26.8% of patients treated with short-course therapy, which did not differ from long-course therapy (range 0-21.1%). Subsequent other infection and mortality rates were also comparable. Quality of available evidence was very low. CONCLUSION: There is no high-quality evidence available to draw a strong conclusion, but heterogeneous observational studies suggest that antibiotic therapy of ≤ 3 days is sufficient in cholangitis patients with common bile duct stones.

Hemorrhagic Shock from Acute Variceal Bleeding Caused by Sarcoidosis: A Case Report.

Sarcoidosis is a disease of unknown etiology, characterized by noncaseating granulomas. Generally, the condition primarily manifests in the lungs. Extrapulmonary involvement is common, but localization in the gastrointestinal system is rare. Here, we present the case of a 37-year-old male who became increasingly hemodynamically unstable during the diagnostic workup for sarcoidosis due to acute variceal bleeding. The underlying mechanism was later attributed to portal hypertension caused by hepatic involvement of the disease. This case demonstrates the importance of considering variceal hemorrhage as a rare but life-threatening complication of gastrointestinal localization of sarcoidosis.

Accuracy for optical diagnosis of small colorectal polyps in nonacademic settings.

BACKGROUND & AIMS: When small colorectal lesions are accurately characterized, adenomas can be removed and discarded without formal histopathology analysis. Previous studies in an academic setting showed that many lesions can be managed accurately on the basis of their endoscopic image (optical diagnosis). We performed a prospective study to assess the accuracy of optical diagnosis of small colorectal polyps in a nonacademic setting (the DISCOUNT trial) by using high-resolution endoscopy (HRE) and narrow-band imaging (NBI). METHODS: During colonoscopy, 1 of 3 nonacademic endoscopists characterized small lesions and declared whether this was done with low or high confidence. In cases of high confidence, the endoscopists decided whether lesions should be removed and discarded or whether they could be left in situ. A surveillance interval was then recommended on-site. RESULTS: Of 215 patients in the study, 108 were found to have 281 small lesions. Of these lesions, 231 were characterized with high confidence by using HRE or NBI; the level of corresponding sensitivity was 77.0% (95% confidence interval, 68.4-83.8), and specificity was 78.8% (95% confidence interval, 70.6-85.2). Of these lesions, 164 were assigned for removal, and 67 were assigned to remain in situ, including 9 adenomas. In 54 patients, a surveillance interval could be recommended on-site that was in line with Dutch guidelines for 44 patients. CONCLUSIONS: Even though many lesions were characterized by HRE or NBI with high confidence, optical diagnosis in a nonacademic setting proved to be disappointing, with a sensitivity of 77.0% and a specificity of 78.8%. Many lesions were accurately assigned to be removed or remain in situ, although few adenomas were assigned to remain in situ. Also, 19% of on-site recommendations for a surveillance interval proved to be inaccurate.

Endoscopic trimodal imaging detects colonic neoplasia as well as standard video endoscopy.

BACKGROUND & AIMS: Endoscopic trimodal imaging (ETMI) is a novel endoscopic technique that combines high-resolution endoscopy (HRE), autofluorescence imaging (AFI), and narrow-band imaging (NBI) that has only been studied in academic settings. We performed a randomized, controlled trial in a nonacademic setting to compare ETMI with standard video endoscopy (SVE) in the detection and differentiation of colorectal lesions. METHODS: The study included 234 patients scheduled to receive colonoscopy who were randomly assigned to undergo a colonoscopy in tandem with either ETMI or SVE. In the ETMI group (n=118), first examination was performed using HRE, followed by AFI. In the other group, both examinations were performed using SVE (n=116). In the ETMI group, detected lesions were differentiated using AFI and NBI. RESULTS: In the ETMI group, 87 adenomas were detected in the first examination (with HRE), and then 34 adenomas were detected during second inspection (with AFI). In the SVE group, 79 adenomas were detected during the first inspection, and then 33 adenomas were detected during the second inspection. Adenoma detection rates did not differ significantly between the 2 groups (ETMI: 1.03 vs SVE: 0.97, P=.360). The adenoma miss-rate was 29% for HRE and 28% for SVE. The sensitivity, specificity, and accuracy of NBI in differentiating adenomas from nonadenomatous lesions were 87%, 63%, and 75%, respectively; corresponding values for AFI were 90%, 37%, and 62%, respectively. CONCLUSIONS: In a nonacademic setting, ETMI did not improve the detection rate for adenomas compared with SVE. NBI and AFI each differentiated colonic lesions with high levels of sensitivity but low levels of specificity.

[Biomarkers of alcohol consumption, an update]. / Biomarkers voor alcoholgebruik.

Alcohol disorder is a growing public health concern, both national and globally. Accurate assessment using standardized questionnaires is an important step towards effective management of the patient suffering from alcohol disorder. The use of biochemical laboratory measures often helps in obtaining independent estimations of alcohol use. Because of (very) low specificity and sensitivity, the use of traditional biomarkers ASAT, ALAT, ASAT-ALAT ratio and MCV is not recommended anymore in the Netherlands. Use of BAC is recommended to detect recent drinking as is CDT measurement in blood, possibly together with gGT, for the diagnosis of chronic excessive alcohol use. EtG in urine can be used for short term monitoring a patient in an abstinence traject. PEth in blood is a very promising biomarker in detecting recent and chronic alcohol consumption as well as monitoring abstinence. The availability of a fast and cheap method for detecting PEth with a well-defined and accepted cut off, are essential study objectives.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery (UPGRADE): a multicentre, double-blind, randomised, placebo-controlled superiority trial.

BACKGROUND: Rapid weight loss is a major risk factor for the formation of cholesterol gallstones. Consequently, patients with morbid obesity undergoing bariatric surgery frequently develop symptomatic gallstone disease. This trial assessed the efficacy of ursodeoxycholic acid versus placebo for the prevention of symptomatic gallstone disease after bariatric surgery. METHODS: This multicentre, double-blind, randomised, placebo-controlled superiority trial enrolled patients with an intact gallbladder scheduled for laparoscopic Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy in three hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module to receive 900 mg ursodeoxycholic acid daily for 6 months or matched placebo. Randomisation was stratified by the presence of asymptomatic gallstones at baseline and type of surgery. Patients, clinicians, and study staff were masked to treatment allocation. The primary endpoint was symptomatic gallstone disease within 24 months, assessed in the modified intention-to-treat population (all randomly assigned eligible patients with any post-randomisation measurement). Prespecified subgroup analyses were done based on the stratification groups. Safety was assessed in all patients who took at least one dose of the study drug. This trial is registered with the Netherlands Trial Register, NL5954. FINDINGS: Between Jan 11, 2017, and Oct 22, 2018, 985 patients were randomly assigned to receive either ursodeoxycholic acid (n=492) or placebo (n=493). 967 patients were included in the modified intention-to-treat population, of whom 959 had data available for primary endpoint assessment. 189 (20%) patients had asymptomatic gallstones at baseline and 78 (8%) received a sleeve gastrectomy. Symptomatic gallstone disease occurred in 31 (6·5%) of 475 patients in the ursodeoxycholic acid group and in 47 (9·7%) of 484 patients in the placebo group (relative risk 0·67, 95% CI 0·43-1·04, p=0·071). Logistic regression showed a significant interaction between ursodeoxycholic acid and the presence of asymptomatic gallstones at baseline (p=0·046), with an effect of ursodeoxycholic acid in patients without (0·47, 0·27-0·84, p=0·0081), and no effect in patients with asymptomatic gallstones at baseline (1·22, 0·61-2·47, p=0·57). The effect was stronger in patients without gallstones at baseline undergoing RYGB (0·37, 0·20-0·71, p=0·0016), whereas the subgroup of patients undergoing sleeve gastrectomy was too small to draw clear conclusions. Adverse events were rare. In the ursodeoxycholic acid group, diarrhoea occurred in four (0·9%) of 444 patients and skin rash in two (0·5%) patients. In the placebo group, diarrhoea occurred in two (0·4%) of 453 patients and skin rash in two (0·4%) patients. The total number of serious adverse events did not significantly differ between the trial groups (75 [17%] in 444 patients in the ursodeoxycholic acid group and 102 [23%] in 453 patients in the placebo group). The most common serious adverse events were abdominal pain and internal hernia. No serious adverse event was attributed to the study drug. INTERPRETATION: Ursodeoxycholic acid prophylaxis did not significantly reduce the occurrence of symptomatic gallstone disease in all patients after bariatric surgery. In patients without gallstones before RYGB surgery, ursodeoxycholic acid treatment reduced the occurrence of symptomatic gallstone disease compared with placebo. Further research is needed to assess the efficacy of ursodeoxycholic acid after sleeve gastrectomy. FUNDING: The Netherlands Organization for Health Research and Development, Zambon Netherlands BV, Foundation for Clinical Research of the Slotervaart Hospital, the Spaarne Gasthuis Academy, and Amsterdam Gastroenterology Endocrinology Metabolism.

Combining autofluorescence imaging and narrow-band imaging for the differentiation of adenomas from non-neoplastic colonic polyps among experienced and non-experienced endoscopists.

OBJECTIVES: Endoscopic tri-modal imaging incorporates high-resolution white-light endoscopy (HR-WLE), narrow-band imaging (NBI), and autofluorescence imaging (AFI). Combining these advanced techniques may improve endoscopic differentiation between adenomas and non-neoplastic polyps. In this study, we aimed to assess the interobserver variability and accuracy of HR-WLE, NBI, and AFI for polyp differentiation and to evaluate the combined use of AFI and NBI. METHODS: First, still images of 50 polyps (22 adenomas; median 3 mm) were randomly displayed to three experienced and four non-experienced endoscopists. All HR-WLE and NBI images were scored for Kudo classification and AFI images for color. Second, the combined AFI and NBI images were assessed using a newly developed algorithm by six additional non-experienced endoscopists. RESULTS: The outcomes measured were interobserver agreement and diagnostic accuracy using histopathology as reference standard. Experienced endoscopists had better interobserver agreement for NBI (kappa=0.77) than for AFI (kappa=0.33), whereas non-experienced endoscopists had better agreement for AFI (kappa=0.58) than for NBI (kappa=0.33). The accuracies of HR-WLE, NBI, and AFI among experienced endoscopists were 65, 70, and 74, respectively. Figures among non-experienced endoscopists were 57, 63, and 77. The algorithm was associated with a significantly higher accuracy of 85% among all observers (P<0.023). These figures were confirmed in the second evaluation study. CONCLUSIONS: Non-experienced endoscopists have better interobserver agreement and accuracy for AFI than for HR-WLE or NBI, indicating that AFI is easier to use for polyp differentiation in non-experienced setting. The newly developed algorithm, combining information of AFI and NBI together, had the highest accuracy and obtained equal results between experienced and non-experienced endoscopists.

[A man with haematochezia and abdominal pain]. / Een man met rectaal bloedverlies en buikpijn.

A 83-year-old male was admitted to the Emergency Department with acute haematochezia and abdominal pain. At digital rectal examination multiple soft distensions were palpable. Sigmoidoscopy revealed ischaemia of the rectum with severe gangrene. The patient was discharged after fluid resuscitation. Follow-up sigmoidoscopy 4 weeks later showed a fully recovered rectum.