Clinical impact of endoscopic ultrasound-guided through-the-needle microbiopsy in patients with pancreatic cysts

Abstract Background The limited data on the utility of endoscopic ultrasound (EUS)-guided through-the-needle biopsies (TTNBs) in patients with pancreatic cystic lesions (PCLs) originate mainly from retrospective studies. Our aim was to determine the clinical impact of TTNBs, their added diagnostic value, and the adverse event rate in a prospective setting. Methods This was a prospective, single-center, open-label controlled study. Between February 2018 and August 2019, consecutive patients presenting with a PCL of 15 mm or more and referred for EUS were included. Primary outcome was a change in clinical management of PCLs following TTNB compared with cross-sectional imaging and cytology. Adverse events were defined according to the ASGE lexicon. Results 101 patients were included. TTNBs led to a change in clinical management in 11.9 % of cases (n = 12). Of these, 10 had serous cysts and surveillance was discontinued, while one of the remaining two cases underwent surgery following diagnosis of a mucinous cystic neoplasm. The diagnostic yield of TTNBs for a specific cyst diagnosis was higher compared with FNA cytology (69.3 % vs. 20.8 %, respectively; P < 0.001). The adverse event rate was 9.9 % (n = 10; 95 % confidence interval 5.4 % – 17.3 %), with the most common event being acute pancreatitis (n = 9). Four of the observed adverse events were severe, including one fatal outcome. Conclusions TTNBs resulted in a change of clinical management in about one in every 10 patients; however, the associated adverse event risk was substantial. Further studies are warranted to elucidate in which subgroups of patients the clinical benefit outweighs the risks.

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Stent Applications for Palliative Treatment in Advanced Stage Esophageal Cancers

Gastroenterology Research and Practice ◽

10.1155/2021/8034948 ◽

2021 ◽

Vol 2021 ◽

pp. 1-5

Author(s):

Mustafa Şentürk ◽

Murat Çakır ◽

Mehmet Aykut Yıldırım ◽

Ömer Kişi

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Palliative Treatment ◽

Event Rate ◽

Adverse Event Rate ◽

Endoscopic Stenting ◽

Covered Stents ◽

Advanced Stage ◽

Esophageal Cancers ◽

Uncovered Stents

Background and Aim. Endoscopic stenting is a generally safe and effective palliative treatment for esophageal malignancies. In this study, we aimed to present endoscopic stent applications, adverse events, and relative advantages of covered versus uncovered stents in our center. Methods. We examined cases of endoscopic stenting for palliative treatment of advanced stage esophageal cancers between January 2014 and July 2019. Age, gender, location of mass, adverse events, survival time, and stent type were evaluated. Outcomes of fully covered and uncovered self-expanding stents were compared with regard to adverse events, including stent migration and occlusion. Results. The mean age of the patients was 66.4 ± 1 , 52 were male, and 8 were female. Patients were followed up for a mean of 133 days. The most common complication due to stenting was migration. 13 patients developed adverse events. Migration was the most common adverse event, occurring in 8 (13%) patients. Although the migration rate of fully covered stents was higher than uncovered stents, there was no statistically significant difference ( p = 0.47 ). Stent occlusion was observed in 4 patients. In three cases, it was due to the tumor; an uncovered stent was placed again in these cases. Food-related occlusion developed in one patient. There was no statistical difference in terms of overall adverse event rate when comparing fully covered stents to uncovered stents ( p = 0.68 ). Conclusion. Endoscopic stenting is a viable palliative method with low morbidity and mortality in experienced centers. Though there are relative advantages with covered versus uncovered stents in individual cases, the overall adverse event rate is low and relatively similar.

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Outcomes of Non-anesthesiologist-Administered Propofol in Pediatric Gastroenterology Procedures

Frontiers in Pediatrics ◽

10.3389/fped.2020.619139 ◽

2021 ◽

Vol 8 ◽

Author(s):

Frances C. Lee ◽

Karen Queliza ◽

Bruno P. Chumpitazi ◽

Amber P. Rogers ◽

Catherine Seipel ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

General Anesthesia ◽

Safety Profile ◽

Event Rate ◽

Adverse Event Rate ◽

Gastrointestinal Adverse Event ◽

Acceptable Safety Profile ◽

Physical Classification ◽

American Society

Background and Aims: Non-anesthesiologist-administered propofol (NAAP) has been found to have an acceptable safety profile in adult endoscopy, but its use remains controversial and pediatric data is limited. Our aim was to examine the safety and efficacy of NAAP provided by pediatric hospitalists in pediatric endoscopy.Methods: We retrospectively reviewed 929 esophagogastroduodenoscopy (EGD), colonoscopy, and combined EGD/colonoscopy cases in children aged 5–20 years between April 2015 and December 2016 at a large children's hospital. We analyzed the data for adverse events in relation to demographics and anthropometrics, American Society of Anesthesiologists physical classification score, presence of a trainee, comorbid conditions, and procedure time.Results: A total of 929 cases were included of which 496 (53%) were completed with NAAP. Seventeen (3.4%) of NAAP cases had an adverse event including the following: 12 cases of hypoxia, 2 cardiac, and 3 gastrointestinal adverse events. General anesthesia cases had 62 (14.3%) adverse events including the following: 54 cases of hypoxia, 1 cardiac, 7 gastrointestinal, and 1 urologic adverse event. No adverse events in either group required major resuscitation. NAAP vs. general anesthesia had a lower overall adverse event rate (3.4 vs. 14.3%, p < 0.0004) and respiratory adverse event rate (2.4% vs. 12.5%, p < 0.0004). Overall, cardiac and gastrointestinal adverse event rates between the two groups were comparable. When accounting for all captured factors via logistic regression, both younger age (P < 0.001) and general anesthesia (P < 0.0001) remained risk factors for an adverse event.Conclusion: The overall adverse event rate of NAAP was low (3.4%) with none requiring major resuscitation or hospitalization. This is comparable to studies of NAAP in adult endoscopy and suggests that NAAP provided by pediatric hospitalists has an acceptable safety profile.

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The Safety of Acupuncture – Evidence from the Uk

Acupuncture in Medicine ◽

10.1136/aim.24.suppl.53 ◽

2006 ◽

Vol 24 (1_suppl) ◽

pp. 53-57 ◽

Cited By ~ 30

Author(s):

Adrian White

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Adverse Reactions ◽

Event Rate ◽

Adverse Event Rate ◽

Serious Adverse Events ◽

Positive Evidence ◽

Safe Treatment ◽

Significant Events ◽

The Uk

Background Patients are attracted to acupuncture partly by its reputation for having low risks. The safety of acupuncture should be established by positive evidence. Methods Two prospective surveys were conducted among different groups of professionals in the UK, including doctors, physiotherapists and practitioners primarily trained in acupuncture. Participants monitored adverse events over a defined period of time, and reported minor and significant events on purpose designed forms. Results A total of 652 acupuncturists reported 6733 adverse reactions including tiredness in 66 229 patients, an adverse event rate of 10.2%. The most common events were tiredness (3%) bleeding or bruising (3%), aggravation of symptoms (2%) and pain at the needling site (1%). There were no serious adverse events. A total of 86 (0.1%) of the treatments was associated with an event that the practitioner judged to be significant though without persistent consequences for the patient's health. Conclusion The risks associated with acupuncture can be classified as negligible, and acupuncture is a very safe treatment in the hands of competent practitioners.

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Endoscopic retrograde pancreatography-guided versus endoscopic ultrasound-guided technique for pancreatic duct cannulation in patients with pancreaticojejunostomy stenosis: a systematic literature review

Endoscopy ◽

10.1055/a-1200-0199 ◽

2020 ◽

Author(s):

Kirill Basiliya ◽

Govert Veldhuijzen ◽

Christian Gerges ◽

Johannes Maubach ◽

Uwe Will ◽

...

Keyword(s):

Adverse Event ◽

Pancreatic Duct ◽

Endoscopic Ultrasound ◽

Event Rate ◽

Outcome Data ◽

Treatment Modalities ◽

Adverse Event Rate ◽

Endoscopic Retrograde Pancreatography ◽

Endoscopic Retrograde ◽

Cannulation Success

Background Stenosis of the pancreaticojejunostomy is a well-known long-term complication of pancreaticoduodenectomy. Traditionally, the endoscopic approach consisted of endoscopic retrograde pancreatography (ERP). Endoscopic ultrasound (EUS)-guided intervention has emerged as an alternative, but the success rate and adverse event rate of both treatment modalities are poorly known. We aimed to compare the outcome data of both interventions. Methods We performed a systematic literature search using the Pubmed/Medline and Embase databases in order to summarize the available data regarding efficacy and complications of ERP- and EUS-guided pancreatic duct (PD) drainage and compare these outcome data using uniform outcome measures in a multilevel logistic model. Results 13 studies were included, involving 77 patients who underwent ERP-guided drainage, 145 who underwent EUS-guided drainage, and 12 patients who underwent both modalities. An EUS-guided approach was significantly superior to an ERP-guided approach with regard to pancreatic duct opacification (87 % vs. 30 %; P < 0.001), cannulation success (79 % vs. 26 %; P < 0.001), and stent placement (72 % vs. 20 %; P < 0.001). An EUS-guided approach also appeared superior with regard to clinical outcomes such a pain resolution. The adverse event rate between the two treatment modalities could not be compared due to insufficient data. All included studies were found to be of low quality. Conclusion Based on limited available data, EUS-guided PD intervention appears superior to ERP-guided PD intervention.

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TM2-2 Analysis of adverse events in the management of chronic headache by occipital nerve stimulation

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2019-abn.41 ◽

2019 ◽

Vol 90 (3) ◽

pp. e13.2-e13

Author(s):

S Miller ◽

L Watkins ◽

M Matharu

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Nerve Stimulation ◽

Event Rate ◽

Adverse Event Rate ◽

Occipital Nerve Stimulation ◽

Occipital Nerve ◽

Significant Difference ◽

Event Rates ◽

The Impact

ObjectivesTo analyse long-term adverse events of occipital nerve stimulation (ONS).DesignProspective open-label observational study.Subjects134 patients with refractory headaches implanted between 2007–2014 in a single specialised centre.MethodsInformation was collected on ONS device, implantable pulse generator (IPG) site and adverse event rates. The impact of implanter experience and the association between IPG site and adverse event rates was also explored.ResultsMean follow up was 46 months (6–108 months). A total of 139 adverse events were recorded in 75 patients (56%). A total of 59 additional surgeries were needed in 39 patients. A significant difference was seen in the rates of adverse events recorded between 2007–2010 and 2011–2014 (60.7% vs 42.6%, p=0.002). A significant reduction in ONS revision was seen over time (25.7% vs 5.9%, p=0.002). Analysis of adverse events with IPG site showed those with abdominal implants recorded higher adverse event rate that those with an IPG in the chest (65.8% vs 40.3%, p=0.004).ConclusionsIn specialist centres, adverse event rates of ONS can be much lower than reported in the literature. Our results suggest implanter experience and IPG site both have an effect on adverse event rate.

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Impact of Antibiotic Prophylaxis on Infection Rate after Endoscopic Ultrasound Through-the-Needle Biopsy of Pancreatic Cysts: A Propensity Score-Matched Study

Diagnostics ◽

10.3390/diagnostics12010211 ◽

2022 ◽

Vol 12 (1) ◽

pp. 211

Author(s):

Antonio Facciorusso ◽

Martha Arevalo-Mora ◽

Maria Cristina Conti Bellocchi ◽

Laura Bernardoni ◽

Daryl Ramai ◽

...

Keyword(s):

Adverse Event ◽

Propensity Score ◽

Antibiotic Prophylaxis ◽

Endoscopic Ultrasound ◽

Needle Biopsy ◽

Mucinous Cystadenoma ◽

Adverse Event Rate ◽

Pancreatic Cysts ◽

Control Group ◽

Cystic Lesions

Background: Despite weak evidence, antibiotic prophylaxis prior to endoscopic ultrasound-guided through-the-needle biopsy (EUS-TTNB) of pancreatic cystic lesions (PCLs) is routinely used in clinical practice. We aim to compare a group of patients treated with antibiotics before EUS-TTNB of PCLs and a group who did not undergo antimicrobial prophylaxis. Methods: Out of 236 patients with pancreatic cystic lesions referred to two high-volume centers between 2016 and 2021, after propensity score matching, two groups were compared: 98 subjects who underwent EUS-TTNB under antibiotic prophylaxis and 49 subjects without prophylaxis. Results: There was no difference in terms of baseline parameters between groups. Final diagnosis was serous cystadenoma in 36.7% of patients in the group not treated with prophylaxis and in 37.7% of patients in the control group, whereas IPMN and mucinous cystadenoma were diagnosed in 3 (6.1%) and 16 (32.6%) versus 6 (6.1%) and 32 (32.6%) patients in the two groups, respectively (p = 0.23). Overall, the adverse event rate was 6.1% in the group not treated with antibiotic prophylaxis and 5.1% in the control group (p = 0.49). Only a single infectious adverse event occurred in each group (p = 0.48). The diagnostic yields were 89.7% and 90.8% in the two groups (p = 0.7), and the diagnostic accuracy rate was 81.6% in both groups (p = 1.0). Conclusions: Prophylactic antibiotics do not seem to influence the risk of infection, and their routine use should be discouraged.

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Impact of physiologically shaped pancreatic stent for chronic pancreatitis

Scientific Reports ◽

10.1038/s41598-021-87852-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yasuki Hori ◽

Yuka Ichino ◽

Itaru Naitoh ◽

Kazuki Hayashi ◽

Michihiro Yoshida ◽

...

Keyword(s):

Adverse Event ◽

Chronic Pancreatitis ◽

Adverse Events ◽

Event Rate ◽

Medical Costs ◽

Adverse Event Rate ◽

Pancreatic Stent ◽

Stent Patency ◽

Related Adverse Event ◽

Pancreatic Duct Obstruction

AbstractEndoscopic pancreatic stenting is used to prevent main pancreatic duct obstruction and relieve painful symptoms of chronic pancreatitis. However, the stent typically needs to be exchanged and the rate of adverse events is high. Few studies have evaluated the effect of stent shape on those outcomes. We evaluated the adverse events, stent patency, and total medical cost within 90 days of patients who received an 8.5 French (Fr) physiologically shaped pancreatic stent by comparing these features with those associated with a conventional straight-type stent for ≥ 90 days. The total stent-related adverse event rate was significantly lower for the physiologically shaped pancreatic stent (physiologically shaped, 6.7% [2/30]; straight-type, 50.6% [44/87]; P < 0.001). Stent occlusion was significantly less frequent (P < 0.001) and the total medical costs were significantly lower (P = 0.002) for the physiologically shaped stent. The stent-related adverse event rate was significantly higher for the 10 Fr straight type stent than for the 8.5 Fr physiologically shaped stent (10 Fr, straight-type vs. 8.5 Fr, physiologically shaped: 36.1% [13/36] vs. 6.7% [2/30]; P = 0.007). In conclusion, a physiologically shaped pancreatic stent was superior to a straight-type stent in terms of the patency rate and medical costs.

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