Can the laser-cut covered self-expandable metallic stent be the first choice for patients with unresectable distal malignant biliary obstruction? (with video).

OBJECTIVES: To evaluate whether laser-cut covered self-expandable metallic stents (LC-CSEMSs) can be the first choice for patients with unresectable distal malignant biliary obstruction (DMBO). METHODS: Patients with unresectable DMBO who received LC-CSEMS (September 2014-December 2020) or braided CSEMS (B-CSEMS) (July 2013-December 2020) placement for biliary drainage were enrolled. Outcomes, including endoscopic CSEMS removal, of LC-CSEMSs and B-CSEMSs were compared. RESULTS: Overall, 124 patients received LC-CSEMSs placement, and 121 B-CSEMSs. Technical success, clinical success, and procedure-related adverse event rates with LC-CSEMSs were 100%, 96.8%, and 6.5%, respectively, and 100%, 95.9%, and 5.8%, respectively, for B-CSEMSs, with no significant difference (P > .99, .75, and >.99, respectively). The recurrent biliary obstruction (RBO) rates with LC-CSEMSs and B-CSEMSs were 9.7% (12/124) and 13.2% (16/121), respectively (P = .43). The median time to RBO with LC-CSEMSs and B-CSEMSs was 198 (interquartile range [IQR], 124-244) days and 191 (IQR, 106-271) days (P = .41). The endoscopic removal success rates of LC-CSEMSs and B-CSEMSs were 88.9% (8/9) and 90% (9/10) (P > .99), although there were a small number of cases. CONCLUSIONS: The non-inferiority of LC-CSEMSs was proven. LC-CSEMSs can be considered as the first choice for patients with unresectable DMBO.

Current Status of Endoscopic Biliary Drainage in Patients with Distal Malignant Biliary Obstruction.

Distal malignant biliary obstruction is caused by various malignant diseases that require biliary drainage. In patients with operable situations, preoperative biliary drainage is required to control jaundice and cholangitis until surgery. In view of tract seeding, endoscopic biliary drainage is the first choice. Since neoadjuvant therapies are being developed, the time to surgery is increasing, especially in pancreatic cancer cases. Therefore, it requires long stent patency. Recently, preoperative biliary drainage using self-expandable metal stents has been reported as a useful modality to secure long stent patency. In patients with unresectable distal malignant biliary obstruction, self-expandable metal stent is the first choice for maintaining long stent patency. Although there are many comparison studies between a covered and an uncovered self-expandable metal stent, their use is still controversial. Recently, endoscopic ultrasound-guided biliary drainage has been performed as an alternative treatment. The clinical success and stent patency are favorable. We should take into consideration that both endoscopic retrograde cholangiopancreatography-guided biliary drainage and endoscopic ultrasound-guided biliary drainage have advantages and disadvantages and chose the drainage method depending on the patient's situation or the expertise of the endoscopist. Here, we discuss the current status of endoscopic biliary drainage in patients with distal malignant biliary obstruction.

Comparison of Endoscopic Ultrasound-Guided Fine-Needle Aspiration and Biopsy Device for Lymphadenopathy.

BACKGROUND: Accurate diagnosis of benign and malignant lymphadenopathy is important for determining the appropriate treatment and prognosis. This study evaluated the diagnostic accuracy and usefulness of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with a conventional needle compared to endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) with a Franseen needle for diagnosing lymphadenopathy. METHODS: Patients who underwent EUS-FNA or EUS-FNB for mediastinal or abdominal lymphadenopathy between July 2013 and August 2020 were enrolled in the study. The outcomes between EUS-FNA patients (July 2013 to January 2017; 22-gauge conventional needle; Group A) and EUS-FNB patients (February 2017 to August 2020; 22-gauge Franseen needle; Group B) were compared. RESULTS: A total of 154 patients (Group A: 83; Group B: 71) were analyzed. The diagnostic accuracy (differentiating between malignant and benign lesions) was 88.0% (95% confidence interval [CI], 79.2-93.3%) in Group A and 95.8% (95% CI, 88.3-98.8%) in Group B. Group B had high diagnostic accuracy, but there was no difference between the groups (p = 0.14). Group B had significantly fewer passes (median 2, interquartile range (IQR): 2-4) than Group A (median 3, IQR: 3-4) (p < 0.001). No procedural adverse events occurred in either group. CONCLUSIONS: Although the diagnostic accuracy between the groups was not statistically significant, EUS-FNB with a Franseen needle provided high diagnostic accuracy and required fewer passes to establish a diagnosis. Thus, EUS-FNB is useful for diagnosing lymphadenopathy.

Diagnostic Process Using Endoscopy for Biliary Strictures: A Narrative Review.

The diagnostic process for biliary strictures remains challenging in some cases. A broad differential diagnosis exists for indeterminate biliary strictures, including benign or malignant lesions. The diagnosis of indeterminate biliary strictures requires a combination of physical examination, laboratory testing, imaging modalities, and endoscopic procedures. Despite the progress of less invasive imaging modalities such as transabdominal ultrasonography, computed tomography, and magnetic resonance imaging, endoscopy plays an essential role in the accurate diagnosis, including the histological diagnosis. Imaging findings and brush cytology and/or forceps biopsy under fluoroscopic guidance with endoscopic retrograde cholangiopancreatography (ERCP) are widely used as the gold standard for the diagnosis of biliary strictures. However, ERCP cannot provide an intraluminal view of the biliary lesion, and its outcomes are not satisfactory. Recently, peroral cholangioscopy, confocal laser endomicroscopy, endoscopic ultrasound (EUS), and EUS-guided fine-needle aspiration have been reported as useful for indeterminate biliary strictures. Appropriate endoscopic modalities need to be selected according to the patient's condition, the lesion, and the expertise of the endoscopist. The aim of this review article is to discuss the diagnostic process for indeterminate biliary strictures using endoscopy.

Recent Advances of Interventional Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound for Patients with Surgically Altered Anatomy.

Endoscopic retrograde cholangiopancreatography (ERCP) is considered to be the gold standard for diagnosis and interventions in biliopancreatic diseases. However, ERCP in patients with surgically altered anatomy (SAA) appears to be more difficult compared to cases with normal anatomy. Since the production of a balloon enteroscope (BE) for small intestine disorders, BE had also been used for biliopancreatic diseases in patients with SAA. Since the development of BE-assisted ERCP, the outcomes of procedures, such as stone extraction or drainage, have been reported as favorable. Recently, an interventional endoscopic ultrasound (EUS), such as EUS-guided biliary drainage (EUS-BD), has been developed and is available mainly for patients with difficult cases of ERCP. It is a good option for patients with SAA. The effectiveness of interventional EUS for patients with SAA has been reported. Both BE-assisted ERCP and interventional EUS have advantages and disadvantages. The choice of procedure should be individualized to the patient's condition or the expertise of the endoscopists. The aim of this review article is to discuss recent advances in interventional ERCP and EUS for patients with SAA.

Novel retrieval basket facilitates the extraction of difficult bile duct stones in a patient with surgically altered anatomy.

Highlight Bile duct stone extraction is sometimes difficult in patients with surgically altered anatomy. Tanisaka and colleagues present a video case report demonstrating the usefulness of a novel retrieval basket with a unique helical shape, which facilitates the extraction of difficult bile duct stones, even in patients with surgically altered anatomy.

Effect of acotiamide on gastric emptying in healthy adult humans.

BACKGROUND: Acotiamide is a first-in-class drug that is used to treat functional dyspepsia (FD). It is considered that acotiamide acts as an antagonist on muscarinic autoreceptors in the enteric nervous system and inhibits acetylcholinesterase activity. We examined the effect of acotiamide on gastric emptying in healthy adult humans. MATERIALS AND METHODS: Twelve healthy adult males were enrolled in this double-blind crossover study. Acotiamide or placebo was administered orally in the 12 subjects 30 min before ingestion of a nutritional liquid meal (400 Kcal/400 mL). Six of the 12 participants took 100 mg of acotiamide or placebo, and six of the 12 participants took 300 mg of acotiamide or placebo in a double-blind crossover fashion. All subjects underwent measurement of gastric emptying by the (13) C breath test. RESULTS: After the meal with placebo was ingested, the %dose/h curve ascended. The %dose/h curve after a meal with 100 or 300 mg of acotiamide ascended in an identical manner compared with the results with placebo. No significant differences were observed at any studied time point, and there were no significant changes in gastric emptying parameters (gastric emptying coefficient, t-1/2ex and t-lag ex). CONCLUSIONS: A single administration of 100 or 300 mg of acotiamide did not affect gastric emptying after a liquid meal in healthy adult humans. Acotiamide has profound effects on restoring delayed gastric emptying and impaired accommodation in patients with FD but may have no effect on gastric emptying in healthy subjects. Such pharmacological actions have not been observed in previous gastroprokinetic studies.

A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia.

OBJECTIVE: To determine the efficacy of acotiamide, an acetylcholinesterase inhibitor, in patients with functional dyspepsia (FD) in a 4-week trial. METHODS: A multicentre, randomised, placebo-controlled, parallel-group, phase III trial was carried out, in which patients with FD received 100 mg of acotiamide or placebo three times a day for 4 weeks, with 4 weeks post-treatment follow-up. The primary efficacy end points were global assessment of overall treatment efficacy (OTE) and elimination rate of all three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation), as derived from daily diaries. Secondary efficacy end points were individual symptom scores and quality of life. Adverse events were monitored. RESULTS: 52.2% of those receiving acotiamide and 34.8% in the placebo group (p<0.001) were classified as responders according to a global assessment of OTE. Over 4 weeks, the elimination rate for all three meal-related symptoms was 15.3% among patients receiving acotiamide compared with 9.0% in the placebo group (p=0.004). The significant benefit of acotiamide over placebo in OTE and elimination rate was maintained during the 4 week post-treatment follow-up. All other secondary efficacy end points, including quality of life, were significantly improved with 100 mg of acotiamide as compared with placebo. The number needed to treat was 6 for OTE and 16 for symptom elimination rate. The incidence of adverse events was similar between the acotiamide group and placebo group and no significant cardiovascular effects due to treatment were seen. CONCLUSIONS: Over 4 weeks, acotiamide significantly improved symptom severity and eliminated meal-related symptoms in patients with FD. TRIAL REGISTRATION NUMBER: http://ClinicalTrials.gov number, NCT00761358.

Estimation of cardiac function with rotary blood pump.

BACKGROUND: A rotary blood pump may be implanted as a bridge to cardiac transplantation. Also, mechanical, histological, and biochemical improvements have been described in cardiac function after the implantation of a left ventricular assists device (LVAD). Thus there is considerable enthusiasm that LVAD might be used as a bridge to the recovery of myocardial function. Unlike a pulsatile pump, however, we cannot stop the rotary blood pump to estimate cardiac function. If the rotary blood pump stops, back flow will occur. In this study, a new method was examined that can estimate cardiac function without stopping the pump. MATERIALS AND METHODS: Twelve pigs were subjected to this acute study. The pump was implanted as an LVAD with an inlet cannula inserted into the left ventricle and the outlet cannula into the ascending aorta. The assist ratio was changed to 75%, from 25%. The relationship between the dp/dt of the left ventricle pressure and the differentiated pump flow rate was examined. Also, cardiac function was changed by epinephrine loading to estimate this method under hyperdynamic heart conditions. RESULTS: There was high positive correlation between the dp/dt of left ventricle pressure and differentiated the pump flow rate to 75% assisted ratio, from 25%. This relationship was established under hyperdynamic conditions. CONCLUSION: This method is simple and useful for estimating the cardiac function without pump stoppage.