PROTon Pump Inhibitors and Stent OCclusion Rate Of Lumen Apposing Metal Stents
NCT ID: NCT05817721
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
893 participants
OBSERVATIONAL
2023-05-05
2024-03-29
Brief Summary
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The main questions this study aims to answer are:
* the individual management of LAMS-occlusion and LAMS-occlusion-related complications in the respective centers participating in the study.
* if there is an association between PPI-intake and LAMS-occlusion and endoscopic necrosectomies.
Participants for the retrospective cohort study will be enrolled retrospectively among European centers with expertise in pancreatology. The expert survey will be distributed European-wide to centers with special expertise in pancreatology.
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Detailed Description
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The investigators therefore aim to perform an expert survey and a retrospective cohort study to elucidate the clinical importance of LAMS-occlusion-related complications and the effect of PPI-intake on occlusion. First, a survey will be sent to European centers with special expertise in pancreatology. Here, the investigators aim to assess the number of LAMS applied annually, whether the experts consider occlusion a clinically relevant complication, and whether there are standard operating procedures for LAMS-occlusion and PPI-discontinuation. Second, the investigators will perform a retrospective multicenter cohort study to assess patient data for PPI intake, frequency of LAMS-occlusion and other complications using a RedCap database.
Quality assurance and data checks of the data entered will be performed by the study coordinator after the initial data entry of the participating centers. For missing data, for which the RedCap form cannot be filled out, the online forms comprise extra fields for "missing data". The data entered in the RedCap online survey will stem from paper or electronic case report forms depending which of these are used at the respective centers. Source data verification will be performed by the participating centers themselves upon data entry into the online questionnaires.
A standard operating procedure will be handed out to the participating centers which will feature any information about how data should be entered. Here, the minimum number of patients which needs to be entered into the study in order to participate will be addressed. The maximum of patients who can be entered is dependent on the respective centers; in principle all patients who received a LAMS for drainage of a WON in the respective centers can be included. As the investigators perform a retrospective study, there will be no need to account for reporting of adverse events.
Based on a power calculation of a preliminary in-house dataset from the University Hospital Goettingen the investigators aim to include a total number of 639 patients.
For missing, unavailable, non-reported or uninterpretable data, the RedCap survey will comprise extra fields as described above. In these, the participating researcher can state that data is missing. If this information is essential for the primary or secondary endpoints of our study, the data entry can be excluded from further analyses by the data monitoring committee.
For the statistical analyses of the data gathered from the expert survey the investigators will apply a Fisher/Chi2-test to assess the clinical relevance as well as the clinical management of LAMS-occlusion and LAMS-occlusion-related complications. For the retrospective cohort study, a Chi2-test will be used to address correlations between PPI-intake and LAMS-occlusion. To assess the frequency of occlusion-related-complications, risk factors for LAMS-occlusion beyond PPI-intake and differences in clinical management of LAMS-occlusion in the respective centers, logistic regression/LASSO will be applied.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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PPI-group
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necroses (WON) upon acute pancreatitis (AP) and were prescribed proton pump inhibitors (PPI) concomitantly
Proton pump inhibitor
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis will be divided into a PPI/Non-PPI group depending on if they concomitantly were prescribed a PPI or not
LAMS-implantation
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis
Non-PPI-group
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necroses (WON) upon acute pancreatitis (AP) and were not prescribed proton pump inhibitors (PPI) concomitantly
LAMS-implantation
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis
Interventions
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Proton pump inhibitor
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis will be divided into a PPI/Non-PPI group depending on if they concomitantly were prescribed a PPI or not
LAMS-implantation
Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis
Eligibility Criteria
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Inclusion Criteria
\- European experts (gastroenterological interventionalists) with expertise in pancreatology
Exclusion Criteria
* Patients in which a LAMS was used to address a postoperative pancreatic fistula (POPF).
* Patients in which concomitant PPI-treatment was not assessed/not documented.
Expert survey:
* Centers which apply less than 10 LAMS per year
* Centers with less than two years experience with LAMS
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University Hospital in Halle
OTHER
University of Leipzig
OTHER
University Hospital Heidelberg
OTHER
Landesklinikum Sankt Polten
OTHER
University Hospital, Aachen
OTHER
University of Oldenburg
OTHER
University of Newcastle Upon-Tyne
OTHER
Szeged University
OTHER
University of Pecs
OTHER
Semmelweis University
OTHER
University of Ulm
OTHER
University Hospital Olomouc
OTHER
Brno University Hospital
OTHER
University Hospital Regensburg
OTHER
Klinikum Stadt Hanau
OTHER
University Medicine Greifswald
OTHER
University Medical Center Goettingen
OTHER
Responsible Party
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Christoph Ammer-Herrmenau
Principal Investigator
Principal Investigators
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Jacob Hamm
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, University Hopsital Goettingen
Christoph Ammer-Herrmenau, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, University Hopsital Goettingen
Volker Ellenrieder, Professor
Role: STUDY_CHAIR
Department of Gastroenterology, University Hopsital Goettingen
Locations
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University Medical Center Goettingen
Goettigen, Lower Saxony, Germany
Countries
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References
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Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
Werge M, Novovic S, Schmidt PN, Gluud LL. Infection increases mortality in necrotizing pancreatitis: A systematic review and meta-analysis. Pancreatology. 2016 Sep-Oct;16(5):698-707. doi: 10.1016/j.pan.2016.07.004. Epub 2016 Jul 9.
Yasuda I, Takahashi K. Endoscopic management of walled-off pancreatic necrosis. Dig Endosc. 2021 Mar;33(3):335-341. doi: 10.1111/den.13699. Epub 2020 Jun 7.
Chandrasekhara V, Barthet M, Deviere J, Bazerbachi F, Lakhtakia S, Easler JJ, Peetermans JA, McMullen E, Gjata O, Gourlay ML, Abu Dayyeh BK. Safety and efficacy of lumen-apposing metal stents versus plastic stents to treat walled-off pancreatic necrosis: systematic review and meta-analysis. Endosc Int Open. 2020 Nov;8(11):E1639-E1653. doi: 10.1055/a-1243-0092. Epub 2020 Oct 22.
Scarpignato C, Gatta L, Zullo A, Blandizzi C; SIF-AIGO-FIMMG Group; Italian Society of Pharmacology, the Italian Association of Hospital Gastroenterologists, and the Italian Federation of General Practitioners. Effective and safe proton pump inhibitor therapy in acid-related diseases - A position paper addressing benefits and potential harms of acid suppression. BMC Med. 2016 Nov 9;14(1):179. doi: 10.1186/s12916-016-0718-z.
Lorenz P, Lynen Jansen P, Beyer G, Hoffmeister A, Lerch MM, Mayerle J. S3-Leitlinie Pankreatitis - Leitlinienreport der Deutschen Gesellschaft fur Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) - September 2021 - AWMF Registernummer 021-003. Z Gastroenterol. 2022 Mar;60(3):e236-e247. doi: 10.1055/a-1713-4244. Epub 2022 Mar 9. No abstract available. German.
Murata A, Ohtani M, Muramatsu K, Matsuda S. Effects of proton pump inhibitor on outcomes of patients with severe acute pancreatitis based on a national administrative database. Pancreatology. 2015 Sep-Oct;15(5):491-496. doi: 10.1016/j.pan.2015.07.006. Epub 2015 Aug 8.
Yoo JH, Kwon CI, Yoo KH, Yoon H, Kim WH, Ko KH, Hong SP, Park PW. [Effect of proton pump inhibitor in patients with acute pancreatitis - pilot study]. Korean J Gastroenterol. 2012 Dec;60(6):362-7. doi: 10.4166/kjg.2012.60.6.362. Korean.
Powers PC, Siddiqui A, Sharaiha RZ, Yang G, Dawod E, Novikov AA, Javia A, Edirisuriya C, Noor A, Mumtaz T, Iqbal U, Loren DE, Kowalski TE, Cosgrove N, Alicea Y, Tyberg A, Andalib I, Kahaleh M, Adler DG. Discontinuation of proton pump inhibitor use reduces the number of endoscopic procedures required for resolution of walled-off pancreatic necrosis. Endosc Ultrasound. 2019 May-Jun;8(3):194-198. doi: 10.4103/eus.eus_59_18.
Martins de Oliveira R, Antunes E, Pedrazzoli J Jr, Gambero A. The inhibitory effects of H+ K+ ATPase inhibitors on human neutrophils in vitro: restoration by a K+ ionophore. Inflamm Res. 2007 Mar;56(3):105-11. doi: 10.1007/s00011-006-6127-6.
Handa O, Yoshida N, Fujita N, Tanaka Y, Ueda M, Takagi T, Kokura S, Naito Y, Okanoue T, Yoshikawa T. Molecular mechanisms involved in anti-inflammatory effects of proton pump inhibitors. Inflamm Res. 2006 Nov;55(11):476-80. doi: 10.1007/s00011-006-6056-4.
Hackert T, Tudor S, Felix K, Dovshanskiy D, Hartwig W, Simon WA, Werner J. Effects of pantoprazole in experimental acute pancreatitis. Life Sci. 2010 Oct 23;87(17-18):551-7. doi: 10.1016/j.lfs.2010.09.008. Epub 2010 Sep 17.
Hamm J, Busana A, Amanzada A, Arlt A, Asendorf T, Carswell S, Denzer U, Elsing L, Frost F, Guilabert L, Hamesch K, Hollenbach M, Hegyi P, Kleger A, Krivinka J, Kunovsky L, Meinhardt C, Phillip V, Schlosser-Hupf S, Sirtl S, Welsch L, Cardinal von Widdern J, Neesse A, Ammer-Herrmenau C; PROTOCOL working group. Effect of proton pump inhibitors on occlusion of lumen-apposing metal stents and rate of endoscopic necrosectomies: a Europe-wide multicenter cohort study. Endoscopy. 2025 Aug;57(8):829-838. doi: 10.1055/a-2569-7056. Epub 2025 Mar 31.
Other Identifiers
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2023-02441
Identifier Type: -
Identifier Source: org_study_id
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