Z Gastroenterol 2016; 54(04): 327-363
DOI: 10.1055/s-0042-102967
Leitlinie
© Georg Thieme Verlag KG Stuttgart · New York

S2k-Leitlinie Helicobacter pylori und gastroduodenale Ulkuskrankheit[1]

S2k-guideline Helicobacter pylori and gastroduodenal ulcer disease
W. Fischbach*
1   Medizinische Klinik II und Klinik für Palliativmedizin, Klinikum Aschaffenburg, Aschaffenburg
,
P. Malfertheiner*
2   Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum Magdeburg, Magdeburg
,
P. Lynen Jansen
3   DGVS Geschäftsstelle, Berlin
,
W. Bolten
4   Innere Medizin, Rheumatologie, spez. Schmerztherapie, Privatpraxis Dr. Peter von Seck, Wiesbaden
,
J. Bornschein
5   MRC Cancer Unit, University of Cambridge, Hutchison/MRC Research Centre, Cambridge, UK
,
S. Buderus
6   GFO-Kliniken Bonn, St. Marien-Hospital, Abt. Pädiatrie, Bonn
,
E. Glocker
7   Institut für Medizinische Mikrobiologie und Hygiene, Universität Freiburg, Freiburg
,
J. C. Hoffmann
8   Medizinische Klinik I, St. Marien- und St. Annastiftskrankenhaus, Ludwigshafen am Rhein
,
S. Koletzko
9   Abteilung Pädiatrische Gastroenterolgoie und Hepatologie, Dr. von Hauner‘sches Kinderspital, Ludwig-Maximilians-Universität München, München
,
J. Labenz
10   Abteilung Innere Medizin, Diakonie Klinikum GmbH, Jung-Stilling-Krankenhaus, Siegen
,
J. Mayerle
11   Klinik und Poliklinik für Innere Medizin A, Zentrum für Innere Medizin, Universitätsmedizin Greifswald, Greifswald
,
S. Miehlke
12   Magen-Darm-Zentrum, Facharztzentrum Eppendorf, Hamburg
,
J. Mössner
13   Klinik und Poliklinik für Gastroenterologie und Rheumatologie, Department für Innere Medizin, Neurologie und Dermatologie, Universitätsklinikum Leipzig, Leipzig
,
U. Peitz
14   Medizinische Klinik II – Gastroenterologie, Raphaelsklinik Münster GmbH, Münster
,
C. Prinz
15   Medizinische Klinik 2 (Gastroenterologie, Diabetologie, Endokrinologie), HELIOS Klinikum Wuppertal, Wuppertal
,
M. Selgrad
16   Klinik und Poliklinik für Innere Medizin I, Universitätsklinikum Regensburg, Regensburg
,
S. Suerbaum
17   Institut für Medizinische Mikrobiologie und Krankenhaushygiene, Zentrum Laboratoriumsmedizin, MHH, Hannover
,
M. Venerito
2   Klinik für Gastroenterologie, Hepatologie und Infektiologie, Universitätsklinikum Magdeburg, Magdeburg
,
M. Vieth
18   Institut für Pathologie, Klinikum Bayreuth
,
Verantwortlich für die DGVS:
› Author Affiliations
Further Information

Publication History

05 February 2016

10 February 2016

Publication Date:
07 April 2016 (online)

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.


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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.


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Anwenderzielgruppe

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


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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


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Themenkomplex 6: Besonderheiten bei Kindern und Jugendlichen

Leiter

Koletzko

München

GPGE

Leiter

Buderus

Bonn

GPGE

Mitglied

Berger

Datteln

GPGE

Literaturrecherche

Koletzko


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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


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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.


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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.


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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.


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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.


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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.


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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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