Abstract:
:The primary aim of the Prä-GIT study is to collect information on the prevalence and course of precancerous and early malignant lesions in the upper GIT (uGIT) as well as risk factors associated with these lesions in asymptomatic individuals. Study participants presenting for a screening colonoscopy will undergo an additional endoscopic examination of the uGIT in the same session. 5000 participants in 30 endoscopy clinics in Bayern will be included. The pilot study presented here was performed to test the main study protocol as well as the acceptance of an additional uGIT endoscopic examination. METHODS: Three endoscopy clinics in Bayern took part in the three-month pilot study between October and December 2018. Patients presenting for a screening colonoscopy in these clinics were offered an additional endoscopic examination of the uGIT which was performed according to a standard operating procedure (SOP). Furthermore, data on dietary habits and lifestyle, as well as biological samples, were collected. RESULTS: 52 participants were included in three clinics in Altötting, Augsburg and Regensburg. The average age was 63.4 years. The average time spent per uGIT endoscopy was 11 minutes. No complications occurred. One participant showed a polyp of the recessus piriformis. Refluxesophagitis was seen in 21 participants, four participants had Barrett's esophagus with histological evidence of low-grade dysplasia in one patient, and an esophageal polyp with low-grade dysplasia was seen in one participant. Helicobacter-pylori gastritis was documented in 12 participants. Corpus-dominant atrophy was described in one participant, while a duodenal adenoma with low-grade dysplasia was seen in two participants. 100 % and 89 % of study participants gave a blood or a stool sample, respectively. All participants answered the questionnaire on dietary and lifestyle habits. CONCLUSION: The Prä-GIT study was designed to generate a database for premalignant and early cancerous lesions of the uGIT in Germany in asymptomatic individuals presenting for a regular screening colonoscopy. The current pilot study has delivered important insights into the feasibility of the main study protocol. Additionally, the pilot study has shown a high rate of acceptance of an additional uGIT examination in this study population. :Im Rahmen der Prä-GIT-Studie sollen Informationen zur Prävalenz und zum Verlauf von präkanzerösen und frühmalignen Läsionen im oberen Gastrointestinaltrakt (OGIT) gewonnen sowie Hochrisikogruppen identifiziert werden. Studienteilnehmer erhalten im Rahmen einer regulären Vorsorgekoloskopie nach vorangegangener Einverständniserklärung in derselben Sitzung eine standardisierte hochauflösende Gastroskopie. Für die Hauptphase der Studie ist geplant, 5000 Teilnehmer in 30 gastroenterologischen Praxen in Bayern einzuschließen. Zur Vorbereitung wurde diese Pilotstudie durchgeführt, um die Machbarkeit des Studienprotokolls, die Akzeptanz der Untersuchung sowie die Durchführung in der „Praxis“-Realität zu prüfen. METHODIK: Drei gastroenterologische Praxen in Bayern nahmen an der dreimonatigen Pilotphase von 10/2018 bis 12/2018 teil. Nach entsprechender Aufklärung wurde Patienten, die sich zur Vorsorgekoloskopie in diesen Praxen vorstellten, zusätzlich eine diagnostische Gastroskopie angeboten. Die Gastroskopien erfolgten nach einer vorgegebenen Arbeitsanweisung (Standard Operating Procedure, SOP). Zusätzlich erfolgten eine Datenerhebung zu Ernährung und Lebensstil anhand eines Selbstausfüllfragebogens sowie die Sammlung von Bioproben. ERGEBNISSE: Innerhalb von 3 Monaten wurden 52 Probanden in drei Praxen in Bayern in die Studie eingeschlossen. Das durchschnittliche Alter lag bei 63,4 Jahren. Die durchschnittliche Untersuchungszeit lag bei 11 Minuten, Komplikationen traten keine auf. Ein Teilnehmer zeigte einen Polyp im Bereich des Recessus piriformis, 21 Teilnehmer zeigten eine Refluxösophagitis, vier Teilnehmer einen Barrett-Ösophagus, davon einer histologisch einen Barrett-Ösophagus mit LGIEN, ein Teilnehmer wies einen Ösophaguspolyp mit leichtgradiger Plattenepitheldysplasie auf, 12 Teilnehmer eine mit Helicobacter pylori assoziierte Gastritis. Eine korpusdominante Atrophie wurde in einem Fall und ein Duodenal-Adenom mit LGIEN in zwei Fällen beschrieben. 100 % bzw. 89 % der Teilnehmer stellten eine Blut- bzw. eine Stuhlprobe für weitere Untersuchungen zur Verfügung. Alle Teilnehmer füllten zudem den Patientenfragebogen aus. ZUSAMMENFASSUNG: Durch die Prä-GIT-Studie soll erstmals für Deutschland eine solide Datenbasis generiert werden, um die Häufigkeiten verschiedener prämaligner und frühkanzeröser Veränderungen im oberen Gastrointestinaltrakt valide schätzen zu können. Die jetzige Pilotphase liefert wichtige Erkenntnisse zur Machbarkeit sowie zur Verbesserung der Prozesse im Rahmen der Hauptphase der Studie. Erfreulicherweise zeigte sich eine sehr große Akzeptanz der Teilnahme an der Studie.
journal_name
Z Gastroenteroljournal_title
Zeitschrift fur Gastroenterologieauthors
Ebigbo A,Römmele C,Meisinger C,Probst A,Beyer A,Arnold J,Beer F,Endlicher E,Schiffelholz W,Linseisen J,Messmann Hdoi
10.1055/a-1190-5332subject
Has Abstractpub_date
2020-08-01 00:00:00pages
761-766issue
8eissn
0044-2771issn
1439-7803journal_volume
58pub_type
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journal_title:Zeitschrift fur Gastroenterologie
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abstract::Within the conversion of the 2nd Council Directive on Driving Licences of the Council of the European Communities (91/439/EEC) into national law, changes became necessary to the Road Traffic Act (StVG) and a new Driving Licence Ordinance (FeV) was created which has been in force since 01.01.1999 (Federal Law Gazette, ...
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doi:10.1055/s-2007-963783
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journal_title:Zeitschrift fur Gastroenterologie
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journal_title:Zeitschrift fur Gastroenterologie
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journal_title:Zeitschrift fur Gastroenterologie
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journal_title:Zeitschrift fur Gastroenterologie
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journal_title:Zeitschrift fur Gastroenterologie
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journal_title:Zeitschrift fur Gastroenterologie
pub_type: 杂志文章
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journal_title:Zeitschrift fur Gastroenterologie
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journal_title:Zeitschrift fur Gastroenterologie
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doi:
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