Dataset Information

Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures (REX-GI study).

ABSTRACT:

Introduction

Recently, the use of various endoscopic procedures under X-ray fluoroscopic guidance, such as endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasonography (EUS), enteral endoscopy and stenting, has been rapidly increasing because of the minimally invasive nature of these procedures compared with that of surgical intervention. With the spread of CT and fluoroscopic interventions, including endoscopic procedures under X-ray guidance, high levels of radiation exposure (RE) from medical imaging have led to major concerns throughout society. However, information about RE related to these image-guided procedures in gastrointestinal endoscopy is scarce, and the RE reference levels have not been established. The aim of this study is to prospectively collect the actual RE dose and to help establish diagnostic reference levels (DRLs) in the field of gastroenterology in Japan.

Methods and analysis

This is a multicentre, prospective observational study that is being conducted to collect the actual RE from treatments and diagnostic procedures, including ERCP, interventional EUS, balloon-assisted enteroscopy, enteral metallic stent placement and enteral tube placement. We will measure the total fluoroscopy time (min), the total dose-area product (Gycm²) and air-kerma (mGy) of those procedures. Because we are collecting the actual RE data and identifying the influential factors through a prospective, nationwide design, this study will provide guidance regarding the DRLs of ERCP, interventional EUS, balloon-assisted enteroscopy, enteral metallic stent placement and enteral tube placement.

Ethics and dissemination

Approval was obtained from the Institutional Review Board of Toyonaka Municipal Hospital (25 April 2019). The need for informed consent will be waived via the opt-out method of each hospital website.

Trial registration number

The UMIN Clinical Trials Registry, UMIN000036525.

SUBMITTER: Nishida T

PROVIDER: S-EPMC7202697 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Publications

Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures (REX-GI study).

Nishida Tsutomu T Hayashi Shiro S Takenaka Mamoru M Hosono Makoto M Kogure Hirofumi H Hasatani Kenkei K Yamaguchi Shinjiro S Maruyama Hirotsugu H Doyama Hisashi H Ihara Hideyuki H Yoshio Toshiyuki T Nagaike Koji K Yamada Takuya T Yakushijin Takayuki T Takagi Tadayuki T Tsumura Hidetaka H Kurita Akira A Asai Satoshi S Ito Yukiko Y Kuwai Toshio T Hori Yasuki Y Maetani Iruru I Ikezawa Kenji K Iwashita Takuji T Matsumoto Kengo K Inada Masami M

BMJ open 20200226 2

<h4>Introduction</h4>Recently, the use of various endoscopic procedures under X-ray fluoroscopic guidance, such as endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasonography (EUS), enteral endoscopy and stenting, has been rapidly increasing because of the minimally invasive nature of these procedures compared with that of surgical intervention. With the spread of CT and fluoroscopic interventions, including endoscopic procedures under X-ray guidance, high le ...[more]

PMID: 32107268

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Project description:BackgroundDiagnostic reference levels (DRLs) are required to optimize medical exposure. However, data on DRLs for interventional fluoroscopic procedures are lacking, especially in gastroenterology. This study aimed to prospectively collect currently used radiation doses and help establish national DRLs for fluoroscopy-guided gastrointestinal procedures in Japan.MethodsThis multicentre, prospective, observational study collected actual radiation dose data from endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasound (EUS), balloon-assisted enteroscopy (BAE), enteral metallic stent placement, and enteral tube placement from May 2019 to December 2020. The study outcomes were fluoroscopy time (FT: min), air kerma at the patient entrance reference point (Ka,r: mGy), air kerma area product (PKA: Gycm2), and radiation dose rate (RDR: mGy/min). Additionally, the basic settings of fluoroscopy equipment and the factors related to each procedure were investigated. This study was registered in the UMIN Clinical Trial Registry (UMIN 000036525).FindingsOverall, 12959 fluoroscopy-guided gastrointestinal procedures were included from 23 hospitals in Japan. For 11162 ERCPs, the median/third quartile values of Ka,r (mGy), PKA (Gycm2), and FT (min) were 69/145 mGy, 16/32 Gycm2, and 11/20 min, respectively. Similarly, these values were 106/219 mGy, 23/41 Gycm2 and 17/27 min for 374 interventional EUSs; 53/104 mGy, 16/32 Gycm2 and 10/15 min for 523 metallic stents; 56/104 mGy, 28/47 Gycm2, and 12/18 min for 599 tube placements; and 35/81 mGy, 16/43 Gycm2 and 7/15 min for 301 BAEs, respectively. For the overall radiation dose rate, the median/third quartile values of RDR were 5.9/9.4 (mGy/min). The RDR values at each institution varied widely.InterpretationThis study reports the current radiation doses of fluoroscopy-guided gastrointestinal procedures expressed as DRL quantities. This will serve as a valuable reference for national DRL values.FundingThis work was supported by a clinical research grant from the Japanese Society of Gastroenterology.

Project description:To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty. Secondary aims were to examine the influence of gestational age on interpretation of mean gestational sac diameter and crown-rump length values, determine the optimal intervals between scans and findings on repeat scans that definitively diagnose pregnancy failure.)Prospective multicentre observational trial.Seven hospital based early pregnancy assessment units in the United Kingdom.2845 women with intrauterine pregnancies of unknown viability included if transvaginal ultrasonography showed an intrauterine pregnancy of uncertain viability. In three hospitals this was initially defined as an empty gestational sac <20 mm mean diameter with or without a visible yolk sac but no embryo, or an embryo with crown-rump length <6 mm with no heartbeat. Following amended guidance in December 2011 this definition changed to a gestational sac size <25 mm or embryo crown-rump length <7 mm. At one unit the definition was extended throughout to include a mean gestational sac diameter <30 mm or embryo crown-rump length <8 mm.Mean gestational sac diameter, crown-rump length, and presence or absence of embryo heart activity at initial and repeat transvaginal ultrasonography around 7-14 days later. The final outcome was pregnancy viability at 11-14 weeks' gestation.The following indicated a miscarriage at initial scan: mean gestational sac diameter ? 25 mm with an empty sac (364/364 specificity: 100%, 95% confidence interval 99.0% to 100%), embryo with crown-rump length ? 7 mm without visible embryo heart activity (110/110 specificity: 100%, 96.7% to 100%), mean gestational sac diameter ? 18 mm for gestational sacs without an embryo presenting after 70 days' gestation (907/907 specificity: 100%, 99.6% to 100%), embryo with crown-rump length ? 3 mm without visible heart activity presenting after 70 days' gestation (87/87 specificity: 100%, 95.8% to 100%). The following were indicative of miscarriage at a repeat scan: initial scan and repeat scan after seven days or more showing an embryo without visible heart activity (103/103 specificity: 100%, 96.5% to 100%), pregnancies without an embryo and mean gestational sac diameter <12 mm where the mean diameter has not doubled after 14 days or more (478/478 specificity: 100%, 99.2% to 100%), pregnancies without an embryo and mean gestational sac diameter ? 12 mm showing no embryo heartbeat after seven days or more (150/150 specificity: 100%, 97.6% to 100%).Recently changed cut-off values of gestational sac and embryo size defining miscarriage are appropriate and not too conservative but do not take into account gestational age. Guidance on timing between scans and expected findings on repeat scans are still too liberal. Protocols for miscarriage diagnosis should be reviewed to account for this evidence to avoid misdiagnosis and the risk of terminating viable pregnancies.

Project description:Background:The use of fluoroscopically-guided interventional (FGI) procedures by orthopedic surgeons has been increasing. This study aimed to investigate the occupational radiation exposure among orthopedic surgeons in South Korea. Methods:A nationwide survey of orthopedic surgeons was conducted in South Korea in October 2017. The dosimetry data of the participants were obtained from the National Dosimetry Registry. The orthopedic surgeons were categorized by job specialty [spine or trauma specialists, other orthopedic specialists, and residents], and descriptive statistics for the demographics and work-related characteristics were presented. Multivariable logistic regression analysis was used to evaluate the risk factors for the orthopedic surgeons who were not linked with the dosimetry data. Results:Among the total participants (n?=?513), 40.5% of the orthopedic surgeons spent more than 50% of their time working with the FGI procedures when compared with their overall work. The average frequency of the FGI procedures among the orthopedic surgeons was 12.3?days per month. Less than 30% of the participants were regularly provided with radiation monitoring badges. The proportion of subjects who always wore lead aprons and thyroid shields were 52 and 29%, respectively. The residents group experienced more unfavorable working conditions of radiation exposure than the other specialists. The dosimetry data were not significantly linked among the residents (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.11-3.95) and orthopedic surgeons working at small hospitals (OR 4.76, 95% CI 1.05-21.51). Conclusions:Although orthopedic surgeons often performed FGI procedures, they wore protective gear less frequently, and a large proportion of orthopedic surgeons were not monitored by the national radiation dosimetry system. As the number of radiation procedures performed by the orthopedic surgeons increases, more intensive approaches are needed to reduce radiation exposure, especially for spine and trauma surgeons.

Project description:BACKGROUND:Nonoperating room anesthesia during gastroenterological procedures is a growing field in anesthetic practice. While the numbers of patients with severe comorbidities are rising constantly, gastrointestinal endoscopic interventions are moving closer to minimally invasive endoscopic surgery. The LMA Gastro™ is a new supraglottic airway device, developed specifically for upper gastrointestinal endoscopy and interventions. The aim of this study was to evaluate the feasibility of LMA Gastro™ in patients with ASA physical status ?3 undergoing advanced endoscopic procedures. METHODS:We analyzed data from 214 patients retrospectively who received anesthesia for gastroenterological interventions. Inclusion criteria were upper gastrointestinal endoscopic interventions, airway management with LMA Gastro™ and ASA status ?3. The primary outcome measure was successful use of LMA Gastro™ for airway management and endoscopic intervention. RESULTS:Thirtyone patients with ASA physical status ?3, undergoing complex and prolonged upper gastrointestinal endoscopic procedures were included. There were 7 endoscopic retrograde cholangiopancreatographies, 7 peroral endoscopic myotomies, 5 percutaneous endoscopic gastrostomies and 12 other complex procedures (e.g. endoscopic submucosal dissection, esophageal stent placement etc.). Of these, 27 patients were managed successfully using the LMA Gastro™. Placement of the LMA Gastro™ was reported as easy. Positive pressure ventilation was performed without difficulty. The feasibility of the LMA Gastro™ for endoscopic intervention was rated excellent by the endoscopists. In four patients, placement or ventilation with LMA Gastro™ was not possible. CONCLUSIONS:We demonstrated the feasibility of the LMA Gastro™ during general anesthesia for advanced endoscopic procedures in high-risk patients. TRIAL REGISTRATION:German Clinical Trials Register (DRKS00017396) Date of registration: 23rd May 2019, retrospectively registered.

Dataset Information

Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures (REX-GI study).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Multicentre prospective observational study protocol for radiation exposure from gastrointestinal fluoroscopic procedures (REX-GI study).

Similar Datasets

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