S2k-Leitlinie Helicobacter pylori und gastroduodenale Ulkuskrankheit^[1]

Kapitel 1: Leitlinienreport

1 Geltungsbereich und Zweck Auswahl des Leitlinienthemas

Auch wenn nach internationalen, populationsbasierten Studien die Prävalenz der Helicobacter pylori (H. pylori)-Infektion in den letzten Jahren abgenommen hat, bleibt etwa 50 % der Weltbevölkerung im Erwachsenenalter über 40 Jahren weiterhin von dieser Infektion betroffen. Anerkannte Präventionsstrategien existieren nicht. Eine wirksame Impfung steht zurzeit nicht zur Verfügung. Die H. pylori-Infektion induziert eine chronisch aktive Gastritis. Mögliche Komplikationen oder Folgeerkrankungen sind dyspeptische Beschwerden, die gastroduodenale Ulkuskrankheit, das distale Magenkarzinom, das primäre gastrale MALT-Lymphom und extradigestive Erkrankungen [1]. Aufgrund der nach wie vor bestehenden Bedeutung der H. pylori-Infektion und neuer Erkenntnisse erfolgen eine Aktualisierung und Weiterentwicklung der Leitlinie von 2009 [2].

Zielorientierung der Leitlinie

Die Leitlinie von 2009 wird überarbeitet. Neue Erkenntnisse zu Definition, Epidemiologie und Resistenzlage von H. pylori sowie Fortschritte in der Diagnostik und Therapie werden bewertet und integriert.

Patientenzielgruppe

Die Leitlinie spricht Empfehlungen für Erwachsene aus, die von einer H. pylori-Infektion, deren Folgekrankheiten oder der nicht mit H. pylori-assoziierten gastroduodenalen Ulkuskrankheit betroffen sind. Spezifische Aspekte der Infektion bei Kindern werden in einem gesonderten Kapitel behandelt.

Versorgungsbereich

Die Leitlinie gilt sowohl für die ambulante als auch die stationäre medizinische Versorgung und behandelt Prävention, Diagnostik und Therapie in der primärärztlichen und der spezialfachärztlichen Versorgung.

Anwenderzielgruppe

Alle an der Beratung, Diagnostik und Therapie der Erkrankung beteiligten Ärzte werden adressiert.

2 Zusammensetzung der Leitliniengruppe und Beteiligung von Interessensgruppen

Die Leitlinie wurde federführend durch die Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) erstellt, die als Koordinatoren Herrn Professor Fischbach, Aschaffenburg, und Herrn Professor Malfertheiner, Magdeburg, beauftragte. Frau PD Dr. med. Lynen-Jansen, DGVS- Geschäftsstelle Berlin, stand bei methodischen Fragestellungen beratend zur Seite und übernahm organisatorische Aufgaben.

Bei der Zusammenstellung der Experten für die zu bearbeitenden Themenkomplexe wurde auf eine für die klinischen Fragestellungen repräsentative Besetzung geachtet. Die für das Thema relevanten Fachgesellschaften wurden angeschrieben und gebeten, Mandatsträger für ihre Organisationen zu benennen. Die Anmeldung der Leitlinie wurde am 1.7.2013 auf der Webseite der AWMF veröffentlicht, sodass weitere Fachgesellschaften/Vertreter sich zur Mitarbeit melden konnten. Experten und Anwender aus den verschiedenen Versorgungsstufen wurden berücksichtigt.

Folgende Fachgesellschaften/Organisationen nahmen teil:

• Deutsche Gesellschaft für Innere Medizin e. V. (DGIM)

  Mandatsträger: Mössner

• Deutsche Gesellschaft für Pathologie e. V. (DGP) und Bundesverband Deutscher Pathologen e. V.

  Mandatsträger: Vieth, Eck, Röcken

• Gesellschaft für Pädiatrische Gastroenterologie und Ernährung e. V. (GPGE)

  Mandatsträger: Koletzko, Buderus, Berger

• Deutsche Gesellschaft für Rheumatologie e. V. (DGRh)

  Mandatsträger: Kellner, Bolten

• Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM)

  Mandatsträger: Glocker, Suerbaum

• Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e. V. (DKG)

  Mandatsträger: Nickenig

• Gastroliga (als Vertreterin der Patienten)

Die Deutsche Gesellschaft für Allgemein- und Familienmedizin (DEGAM) sagte eine Beteiligung ab. Die allgemeinmedizinische Perspektive wurde durch M. Hollenz, Rödental, vertreten.

Am 21.5.2014 erfolgte ein erstes Treffen (Kick-off-Treffen) der Koordinatoren, Mandatsträger und der Leiter der Arbeitsgruppen, bei dem Besetzung der Themenkomplexe festgelegt wurde.

Durch die Koordinatoren wurde vorab eine Recherche nach aktuellen Leitlinien, Metaanalysen, systematischen Reviews und randomisierten Studien durchgeführt, auf deren Basis die Empfehlungen der alten Leitlinie diskutiert wurden. Es wurde festgelegt, welche Empfehlungen unverändert übernommen, überarbeitet oder gestrichen werden sollten. Neue Empfehlungen wurden auf Vorschlag der Teilnehmer oder auf Basis der von Herrn Fischbach seit 2009 dokumentierten Kommentare, Fragen und Vorschläge zur alten Leitlinie ergänzt.

Für jeden Themenkomplex wurde eine Person benannt, die für die Literaturrecherche zuständig war. Bei der personellen Besetzung der einzelnen Themenkomplexe wurden, wenn möglich, Fachkompetenz, eine interdisziplinäre Verteilung und der jeweilige Tätigkeitsbereich (niedergelassen und stationär) berücksichtigt:

Themenkomplex 1: Epidemiologie

Leiter	Mayerle	Greifswald	DGVS
Mitglied	Scherübl	Berlin	DGVS
Mitglied	Storr	München	DGVS
Mitglied	Venerito	Magdeburg	DGVS
Mitglied	Rad	München	DGVS
Literaturrecherche	Venerito

Themenkomplex 2: Diagnostik

Leiter	Glocker	Freiburg	DGHM
Leiter	Peitz	Münster	DGVS
Mitglied	Suerbaum	Hannover	DGHM
Mitglied	Leodolter	Herne	DGVS
Mitglied	Rosien	Hamburg	DGVS
Mitglied	Vabanova	Magdeburg
Literaturrecherche	Vieth, Peitz

Themenkomplex 3: Indikation zur Therapie

Leiter	Fischbach	Aschaffenburg	DGVS
Leiter	Mössner	Leipzig	DGIM
Mitglied	Layer	Hamburg	DGVS
Mitglied	Eck	Aschaffenburg	DGP/BDP
Mitglied	Koop	Berlin	DGVS
Mitglied	Mönnikes	Berlin	DGVS
Mitglied	Kellner	München	DGRh
Literaturrecherche	Fischbach, Eck

Themenkomplex 4: Prävention

Leiter	Malfertheiner	Magdeburg	DGVS
Leiter	Vieth	Bayreuth	DGP/BDP/DGVS
Mitglied	Flieger	Rüsselsheim	DGVS
Mitglied	Meining	München	DGVS
Mitglied	Möhler	Mainz	DGVS
Mitglied	Bornschein	Cambridge	DGVS
Mitglied	Ebert	Mannheim	DGVS
Literaturrecherche	Bornschein

Themenkomplex 5: Therapie der Helicobacter pylori-Infektion

Leiter	Labenz	Siegen	DGVS
Leiter	Miehlke	Hamburg	DGVS
Mitglied	Madisch	Hannover	DGVS
Mitglied	Wagner	Deggendorf	DGVS
Mitglied	Selgrad	Magdeburg	DGVS
Literaturrecherche	Miehlke, Selgrad

Themenkomplex 6: Besonderheiten bei Kindern und Jugendlichen

Leiter	Koletzko	München	GPGE
Leiter	Buderus	Bonn	GPGE
Mitglied	Berger	Datteln	GPGE
Literaturrecherche	Koletzko

Themenkomplex 7: Nicht mit Helicobacter pylori-assoziierte gastroduodenale Ulkuserkrankungen

Leiter	Hoffmann	Ludwigshafen	DGVS
Leiter	Prinz	Wuppertal	DGVS
Mitglied	Röcken	Kiel	DGP/BDP
Mitglied	Bolten	Wiesbaden	DGRh
Mitglied	Gross	München	DGVS
Mitglied	Jung	Mainz	DGVS
Mitglied	Schepp	München	Gastroliga
Mitglied	Nickenig	Bonn	DKG
Mitglied	Siegmund	Berlin
DGVS Literaturrecherche	Hoffmann, Prinz

3 Methodologische Exaktheit Literaturrecherche und Auswahl der Evidenz

Um den Aktualisierungsbedarf festzulegen wurden durch die Koordinatoren Kommentare und Ergänzungsvorschläge seit 2009 gesammelt.

Im Vorfeld des ersten Treffens führten die Koordinatoren eine Suche nach verfügbaren Quellen aggregierter Evidenz durch. Existierende Leitlinien und Metaanalysen wurden auf dem Kick-off-Treffen vorgestellt. Die erweiterte Literatursuche erfolgte in Pubmed und Cochrane databases. Weitere Artikel und Studien konnten bei Bedarf mit einbezogen werden.

Alle Suchergebnisse sowie alle relevanten Publikationen im Volltext wurden über ein webbasiertes Leitlinienportal der Leitliniengruppe zur Verfügung gestellt.

Literatur wurde bis zum Termin der Konsensuskonferenz am 18.3.2015 berücksichtigt.

Formulierung der Empfehlungen und strukturierte Konsensfindung:

Auf Grundlage der Literatur wurden die Empfehlungen durch die AG-Leiter aktualisiert bzw. neu erarbeitet und zunächst im Email-Umlaufverfahren innerhalb der einzelnen Themenkomplexe abgestimmt. Die Graduierung der Empfehlungen erfolgte über die Formulierung soll, sollte, kann ([Tab. 1]). Die Empfehlungen wurden in einem Delphiverfahren von allen Leitlinienmitarbeitern mithilfe einer 3-stufigen Entscheidungsskala abgestimmt (ja, unentschieden, nein). Zu Empfehlungen, die nicht mit ja abgestimmt wurden, musste ein begründender Kommentar hinterlegt werden. Empfehlungen, die zu über 95 % mit ja abgestimmt worden waren, wurden bereits zu diesem Zeitpunkt verabschiedet ([Tab. 2]).

Tab. 1 Schema zur Graduierung von Empfehlungen.[1]

Syntax	Beschreibung
soll	starke Empfehlung
sollte	Empfehlung
kann	Empfehlung offen

¹ Negative Empfehlungen werden entsprechend formuliert.

Tab. 2 Konsensfindung.

Konsens	% Zustimmung
starker Konsens	> 95
Konsens	> 75 – 95
mehrheitliche Zustimmung	50 – 75
kein Konsens	< 50

Tab. 3 Zeitplan.

März 2013	Beauftragung der Koordinatoren durch die DGVS
Juli 2013	Anmeldung bei der AWMF
Mai 2014	Kick-off-Treffen Berlin
Februar 2015	Delphiverfahren
März 2015	Konsensuskonferenz Berlin

Die Kommentare und Änderungsvorschläge der Delphirunde wurden von den Koordinatoren gesichtet und ausgewertet. Alle Empfehlungen, die in der ersten Abstimmung weniger als 95 % Zustimmung erhalten hatten, wurden innerhalb der Themenkomplexe überarbeitet und auf der abschließenden Konsensuskonferenz erneut diskutiert. Die Konferenz wurde unabhängig durch Herrn Professor Fischbach und Frau PD Dr. Lynen moderiert. In einem nominalen Gruppenprozess wurden Änderungsvorschläge gesammelt, dokumentiert und anschließend eine finale Version mittels TED-System abgestimmt. Das Ergebnis der Abstimmung wurde dokumentiert und die Konsensusstärke gemäß [Tab. 2] festgelegt. Im Anschluss an die Konsensuskonferenz erfolgte die finale Überarbeitung der Kommentare durch die Leiter der Themenkomplexe und die redaktionelle Zusammenstellung der Leitlinie durch die Koordinatoren.

4 Externe Begutachtung und Verabschiedung

Die Leitlinie wurde allen beteiligten Fachgesellschaften zur Stellungnahme vorgelegt und von diesen verabschiedet. Durch die AWMF erfolgte eine externe formale Beurteilung.

5 Redaktionelle Unabhängigkeit und Umgang mit potenziellen Interessenskonflikten

Die Leitlinie wurde von der DGVS finanziert. Vertreter der pharmazeutischen Industrie waren nicht am Prozess der Leitlinienentwicklung beteiligt, um Neutralität und Unabhängigkeit zu wahren. Vor Beginn der Konsensuskonferenz legten alle Teilnehmer ihre potenziellen Interessenskonflikte offen. Hierfür wurden Interessenkonflikte schriftlich mithilfe eines Formblattes der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), das materielle und immaterielle Interessen umfasst, festgehalten und der Leitliniengruppe tabellarisch zur Verfügung gestellt. Die Bewertung der Angaben zu Interessenkonflikten erfolgte durch die gesamte Leitliniengruppe. Potenzielle Interessenskonflikte wurden offen diskutiert. Einstimmig wurde beschlossen, dass Personen mit potenziellen Interessenskonflikten bei Abstimmungen über Empfehlungen, die von diesen Interessenskonflikten berührt werden könnten, sich ihrer Stimme enthalten. Eine Übersicht potenzieller Interessenskonflikte ist im Anhang dargestellt.

6 Verbreitung und Implementierung

Die Leitlinie sowie der Methodenreport werden auf der Homepage der DGVS (www.dgvs.de) und der AWMF (www.awmf.de) zum freien Download zur Verfügung gestellt. Die Langversion der Leitlinie wird in der „Zeitschrift für Gastroenterologie“ in deutscher Sprache publiziert. Unterstützend wird eine Leitlinien-App zur Verfügung gestellt. Die Leitlinienempfehlungen werden darüber hinaus auf den Kongressen und themenbezogenen Fortbildungsveranstaltungen der DGVS vorgestellt.

7 Gültigkeitsdauer und Aktualisierungsverfahren

Die Gültigkeit der Leitlinie beträgt 5 Jahre (Juli 2020). Eine Überarbeitung der Leitlinie bei veränderter Datenlage erfolgt gegebenenfalls auch früher. Das Aktualisierungsverfahren wird koordiniert durch die DGVS Geschäftsstelle.

¹ Gemeinsame Leitlinie der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) in Zusammenarbeit mit Deutsche Gesellschaft für Pathologie e. V. (DGP) und Bundesverband Deutscher Pathologen e. V., Gesellschaft für Pädiatrische Gastroenterologie und Ernährung e. V. (GPGE), Deutsche Gesellschaft für Rheumatologie e. V. (DGRh), Deutsche Gesellschaft für Hygiene und Mikrobiologie e. V. (DGHM), Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e. V. (DKG) und GastroLiga (AWMF Register-Nr. 021 – 001 – Aktualisierung).

^* Gleichberechtigte durch die DGVS mandatierte Koordinatoren der Leitlinie.

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