Accuracy of Endoscopic Transpapillary Gallbladder Drainage with Liquid-Based Cytology for Gallbladder Disease

Digestion ◽  
2021 ◽  
pp. 1-10
Author(s):  
Soichiro Kawahara ◽  
Takeshi Tomoda ◽  
Hironari Kato ◽  
Toru Ueki ◽  
Yutaka Akimoto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diagnostic Accuracy ◽  
Success Rate ◽  
Cystic Duct ◽  
Gallbladder Disease ◽  
Drainage Tube ◽  
Clinical Trial Registry ◽  
Gallbladder Drainage ◽  
Gallbladder Diseases

<b><i>Introduction:</i></b> Gallbladder carcinoma is often difficult to distinguish from benign gallbladder diseases. While the diagnostic accuracy of endoscopic transpapillary gallbladder drainage (ETGD) has been reported, these results were obtained retrospectively. This prospective study aimed to evaluate the cytological diagnostic accuracy of ETGD in patients with gallbladder disease. <b><i>Methods:</i></b> This single-arm prospective clinical trial included a total of 35 patients scheduled to undergo ETGD between March 2017 and September 2019. A 5F pigtail nasobiliary drainage tube was inserted into the gallbladder, and bile was collected over 5 times; if ETGD failed, a drainage tube was placed into the bile duct. The endpoints were, first, the cytological diagnostic accuracy of ETGD and, second, technical success rates and adverse events. <b><i>Results:</i></b> Of the 35 patients, 19 were finally diagnosed with gallbladder cancer. The success rate of ETGD tube insertion was 85.7%, and the morphological pattern of the cystic duct with the angle down and located on the right side had a significantly lower success rate for ETGD than that of other cystic duct patterns (odds ratio, 13.5; 95% confidence interval, 1.7–143.7; <i>p</i> = 0.02). Cytological samples were collected 5 times on median. The sensitivity, specificity, and accuracy in all patients were 78.9%, 100%, and 88.6%, respectively, while those in 30 patients with successful ETGD were 87.5%, 100%, and 93.3%, respectively. Adverse events occurred in 3 patients: mild pancreatitis in 1 patient and obstructive jaundice in 2 patients; all complications were resolved with conservative therapy. <b><i>Discussion/Conclusions:</i></b> Cytology using an ETGD tube is useful in differentiating benign and malignant gallbladder diseases (Clinical Trial Registry No. UMIN000026929).

Diagnosis and Patients Management of Gallbladder Disease by Bile Cytology Using Endoscopic Transpapillary Gallbladder Drainage Tube

2004 ◽  
Vol 59 (5) ◽  
pp. P182
Author(s):  
Takao Itoi ◽  
Kazuto Nakamura ◽  
Atsushi Sofuni ◽  
Fumihide Itokawa ◽  
Kazuhiro Kakimi ◽  
...  
Keyword(s):  
Gallbladder Disease ◽  
Drainage Tube ◽  
Gallbladder Drainage ◽  
Bile Cytology

Bioequivalence of a Generic Nateglinide Formulation in Healthy Chinese Volunteers under Fasting and Fed Conditions: A Randomized, Open-Label, Double-Cycle, Double-Crossover Study

Pharmacology ◽  
2021 ◽  
pp. 1-8
Author(s):  
Ming Yu ◽  
Xiaobin Li ◽  
Hao Jin ◽  
Lu Chen ◽  
Nan Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Vital Signs ◽  
Reference Formulation ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Laboratory Test Results ◽  
Liquid Chromatography Tandem Mass ◽  
Healthy Chinese

<b><i>Introduction:</i></b> Nateglinide or <i>N</i>-(trans-4-isopropylcyclohexyl-1-carbonyl)-D-phenylalanine is a drug with a rapid hypoglycemic effect that is mainly used in the treatment of type 2 diabetes. Very few studies have assessed bioequivalence based on feeding status. This study aimed to assess the pharmacokinetic bioequivalence and safety of nateglinide-containing tablets (0.12 g) in healthy Chinese volunteers under fasting and fed conditions. <b><i>Methods:</i></b> The studies were performed in 2017–2018 in the Phase I Clinical Trial Ward of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China. Eligible Chinese volunteers received a single 0.12-g dose of the test or reference formulation, followed by a 7-day washout period and administration of the alternate formulation. Blood samples were collected at various time intervals, and plasma nateglinide concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Then, the adverse events, laboratory test results, vital signs, and physical exam findings were compared between the 2 groups. <b><i>Results:</i></b> The ratios of the geometric means of C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-inf</sub> of the tested to reference preparations under fasting conditions were 105.03% (90% confidence interval [CI]: 99.53–110.83%), 104.02% (90% CI: 101.37–106.74%), and 104.04% (90% CI: 101.38–106.77%), respectively. The same ratios under fed conditions were 96.55% (90% CI: 85.80–108.65%), 103.08% (90% CI: 100.07–106.18%), and 103.07% (90% CI: 100.21–106.01%), respectively. The 90% CI values for C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-inf</sub> fell within the accepted range of bioequivalence (80.00–125.0%). Common adverse events included hypoglycemia, heart rate increase, palpitation, sweating, dizziness, and diarrhea. <b><i>Conclusions:</i></b> The test formulation (0.12 g) met the CFDA’s regulatory definition for bioequivalence to the reference formulation. Both formulations were well tolerated by healthy Chinese subjects. <b><i>Trial Registration:</i></b> This trial has been registered in the Chinese Clinical trial registry (ChiCTR2000030694), March 10, 2020.

scholarly journals Comparison of GlideScope™ visualization and neck flexion with lateral neck pressure nasogastric tube insertion techniques in anesthetized patients: a randomized clinical study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pitchaporn Purngpipattrakul ◽  
Suttasinee Petsakul ◽  
Sunisa Chatmonkolchart ◽  
Kanjana Nuanjun ◽  
Somrutai Boonchuduang
Keyword(s):  
Clinical Trial ◽  
Success Rate ◽  
Nasogastric Tube ◽  
Lateral Neck ◽  
Neck Flexion ◽  
Success Rates ◽  
Clinical Trial Registry ◽  
Randomized Clinical Study ◽  
Time Required ◽  
Neck Pressure

Abstract Objective Nasogastric tube (NGT) insertion in anesthetized and intubated patients can be challenging, even for experienced anesthesiologists. Various techniques have been proposed to facilitate NGT insertion in these patients. This study aimed to compare the success rate and time required for NGT insertion between GlideScope™ visualization and neck flexion, with lateral neck pressure techniques. Material and methods This randomized clinical trial was performed at a teaching hospital on 86 adult patients undergoing abdominal surgery, under relaxant general anesthesia, who required intraoperative NGT insertion. The patients were randomized into two groups, the GlideScope™ group (group G) and the neck flexion with lateral neck pressure group (group F). The success rate of the first and second attempts, duration of insertion, and complications were recorded. Results The total success rate was 79.1% in group G, compared with 76.7% in group F (P = 1). The median time required for NGT insertion was significantly longer in group G, for both first and second attempts (97 vs 42 s P < 0.001) and (70 vs 48.5 s P = 0.015), respectively. Complications were reported in 23 patients (53.5%) in group G and 13 patients (30.2%) in group F. Bleeding and kinking were the most common complications for both techniques. Conclusion Using GlideScope™ visualization to facilitate NGT insertion was comparable to neck flexion with lateral neck pressure technique, in the degree of success rates of insertion. Although complications were not statistically significant between groups, neck flexion with lateral neck pressure technique was significantly less time-consuming for both first and second attempts. Trial registration Retrospectively registered: Thai Clinical Trial Registry (TCTR)20171229003. Registered on 19 December 2017

scholarly journals Personalized neoantigen vaccine prevents postoperative recurrence in hepatocellular carcinoma patients with vascular invasion

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhixiong Cai ◽  
Xiaoping Su ◽  
Liman Qiu ◽  
Zhenli Li ◽  
Xiaolou Li ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Immune Response ◽  
Adverse Events ◽  
Clinical Response ◽  
Radical Surgery ◽  
Individualized Medicine ◽  
Postoperative Recurrence ◽  
Clinical Relapse ◽  
Clinical Trial Registry

Abstract Background Clinically, prophylactic anti-recurrence treatments for hepatocellular carcinoma (HCC) patients after radical surgery are extremely limited. Neoantigen based vaccine can generate robust anti-tumor immune response in several solid tumors but whether it could induce anti-tumor immune response in HCC and serve as a safe and effective prophylactic strategy for preventing postoperative HCC recurrence still remain largely unclear. Methods Personalized neoantigen vaccine was designed and immunized for 10 HCC patients with high risk of postoperative recurrence in a prime-boost schedule. The safety and immune response were assessed through adverse events, tissue sequencing, ELISpot, TCR sequencing. The clinical response was evaluated by recurrence-free survival (RFS) and personalized circulating tumor DNA (ctDNA) sequencing. Results In the 10 enrolled patients, no obvious adverse events were observed during neoantigen vaccinations. Until the deadline of clinical trial, 8 of 10 patients were confirmed with clinical relapse by imaging, the other 2 patients remained relapse-free. From receiving first neoantigen vaccination, the median RFS of 10 patients were 7.4 months. Among 7 patients received all planned neoantigen vaccinations, 5 of them demonstrated neoantigen-induced T cell responses and have significantly longer RFS after radical surgery than other 5 patients without responsive neoantigens or only with prime vaccination and propensity scores matching control patients (p = 0.035). Moreover, tracking personalized neoantigen mutations in ctDNA could provide real-time evaluation of clinical response in HCC patients during neoantigen vaccination and follow up. Conclusion Personalized neoantigen vaccine is proved as a safe, feasible and effective strategy for HCC anti-recurrence, and its progression could be sensitively monitored by corresponding neoantigen mutations in ctDNA, and thus provided solid information for individualized medicine in HCC. Trial registration This study was registered at Chinese Clinical Trial Registry; Registration number: ChiCTR1900020990.

scholarly journals Investigating Origins of Ventricular Arrhythmia Arising From Right Ventricular Outflow Tract and Comparing Initial Ablation Strategies

2021 ◽  
Vol 8 ◽  
Author(s):  
Zhi Jiang ◽  
Qifang Liu ◽  
Ye Tian ◽  
Yidong Zhao ◽  
Wei Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Right Ventricular ◽  
Success Rate ◽  
Right Ventricular Outflow Tract ◽  
Ventricular Outflow Tract ◽  
Outflow Tract ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Qualitative Interaction ◽  
Activation Mapping

Background: The origin distribution in right ventricular outflow tract (RVOT) ventricular arrhythmias (VAs), as well as the initial ablation effectiveness of reversed U-curve method and antegrade method, remains unclear.Objectives: To investigate the origin distribution of RVOT-type VAs and compare the initial ablation effectiveness of the two methods.Method: Consecutive patients who had idiopathic RVOT-type VAs were prospectively enrolled. After activation mapping, patients were randomly assigned to supravalvular strategy using the reversed U-curve or subvalvular strategy using the antegrade method. The primary outcome was initial ablation (IA) success, defined as the successful ablation within the first three attempts.Results: Sixty-one patients were enrolled from November 2018 to June 2020. Activation mapping revealed that 34/61 (55.7%) of the earliest ventricular activating (EVA) sites were above the pulmonary valves (PVs). The IA success rate was 25/33 (75.8%) in the patients assigned to supravalvular strategy as compared with 16/28 (57.1%) in those assigned to subvalvular strategy (p = 0.172). Multivariate analysis revealed a substantial and qualitative interaction between the EVA sites and IA strategies (pinteraction &lt; 0.001). Either strategy had a remarkably higher IA success rate in treating its ipsilateral EVA sites than contralateral ones (p &lt; 0.0083).Conclusion: Of the idiopathic RVOT-type VA origins, half were located above the PV. The supravalvular and subvalvular strategies did not differ in IA success rates. However, they were complementary to reveal the EVA sites and facilitate ipsilateral ablation, which produces a significantly higher IA success rate.Clinical Trial Registration: Chinese Clinical Trial Registry number, https://www.chictr.org.cn/showproj.aspx?proj=45623, ChiCTR2000029331.

scholarly journals A Prospective, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Using an Orally Administered Oxalate Decarboxylase (OxDC)

Kidney360 ◽  
2020 ◽  
Vol 1 (11) ◽  
pp. 1284-1290
Author(s):  
Emily Quintero ◽  
Victoria Yvonne Bird ◽  
Howard Liu ◽  
Gary Stevens ◽  
Alan S. Ryan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Healthy Volunteers ◽  
Urinary Oxalate ◽  
Oxalate Decarboxylase ◽  
Clinical Trial Registry ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Registration Number ◽  
Urinary Parameters

BackgroundHyperoxaluria is typically associated with excessive oxalate intake in the diet, decreased dietary calcium, hyperabsorption of oxalate, or increased endogenous production of oxalate. The disorder spectrum extends from recurrent kidney stones to ESKD. This clinical trial sought to evaluate the effectiveness of an acid stable oxalate decarboxylase (OxDC) to reduce urinary oxalate in healthy subjects on a high-oxalate diet.MethodsIn this prospective, double-blind, randomized, placebo-controlled, crossover clinical trial, 33 healthy volunteers were randomized into two crossover sequences separated by a 2-day washout period. A controlled high-oxalate diet (750–800 mg oxalate, 500–550 mg calcium daily) was utilized, and six 24-hour urine collections were measured. Subjects were given approximately 1000 U (micromoles per minute per milligram) of OxDC or placebo with meals three times daily during the 4 days of treatment.ResultsUrinary oxalate significantly decreased with OxDC treatment. The baseline corrected within-subject mean reduction in 24-hour urinary excretion (after OxDC dosing versus high-oxalate baseline preceding treatment) was 12.5 mg or 29% (P<0.001). OxDC treatment was effective (>5% reduction) in 31 of 33 subjects (94%). Compared with placebo, OxDC produced a 24% reduction (P<0.001) in 24-hour oxalate excretion. Other urinary parameters (creatinine, uric acid, citrate, magnesium, calcium) were not affected by OxDC. No serious adverse events and no product-related adverse events occurred.ConclusionsAn orally administered OxDC is capable of significantly reducing urinary oxalate levels in healthy volunteers on a high-oxalate diet without affecting creatinine clearance, urine creatinine, or other solutes related to supersaturation of calcium oxalate.Clinical Trial registry name and registration number:Evaluation of Nephure, and the Reduction of Dietary Oxalate, in Healthy Volunteers, NCT03661216

scholarly journals An Evaluation of the Diagnostic Accuracy of a Panel of Variants in DPYD and a Single Variant in ENOSF1 for Predicting Common Capecitabine Related Toxicities

Cancers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1497
Author(s):  
Claire Palles ◽  
Susan Fotheringham ◽  
Laura Chegwidden ◽  
Marie Lucas ◽  
Rachel Kerr ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diagnostic Accuracy ◽  
Dihydropyrimidine Dehydrogenase ◽  
Area Under The Curve ◽  
Toxicity Tests ◽  
Serious Adverse Events ◽  
Significant Toxicity ◽  
Good Diagnostic Accuracy ◽  
High Level

Efficacy of 5-Fluorouracil (5-FU)-based chemotherapy is limited by significant toxicity. Tests based upon variants in the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines with high level evidence of a link to dihydropyrimidine dehydrogenase (DPD) phenotype and 5-FU toxicity are available to identify patients at high risk of severe adverse events (AEs). We previously reported associations between rs1213215, rs2612091, and NM_000110.3:c.1906-14763G>A (rs12022243) and capecitabine induced toxicity in clinical trial QUASAR 2. We also identified patients with DPD deficiency alleles NM_000110.3: c.1905+1G>A, NM_000110.3: c.2846C>T, NM_000110.3:c.1679T>G and NM_000110.3:c.1651G>A. We have now assessed the frequency of thirteen additional DPYD deficiency variants in 888 patients from the QUASAR 2 clinical trial. We also compared the area under the curve (AUC)—a measure of diagnostic accuracy—of the high-level evidence variants from the CPIC guidelines plus and minus additional DPYD deficiency variants and or common variants associated with 5-FU toxicity. Including additional DPYD deficiency variants retained good diagnostic accuracy for serious adverse events (AEs) and improved sensitivity for predicting grade 4 haematological toxicities (sensitivity 0.75, specificity 0.94) but the improvement in AUC for this toxicity was not significant. Larger datasets will be required to determine the benefit of including additional DPYD deficiency variants not observed here. Genotyping two common alleles statistically significantly improves AUC for prediction of risk of HFS and may be clinically useful (AUC difference 0.177, sensitivity 0.84, specificity 0.31).

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

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