PROTon Pump Inhibitors and Stent OCclusion Rate Of Lumen Apposing Metal Stents

NCT05817721 | Completed DMC

• 1 other identifier: 2023-02441
• Study Type: observational
• Target: 893
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational retrospective cohort study in combination with an expert study is to assess the clinical relevance and management of Lumen apposing metal stent (LAMS)-occlusion and LAMS-occlusion-related complications as well as the influence of proton pump inhibitors (PPI) on LAMS-occlusion. 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.

Conditions

Acute Pancreatitis

Keywords

acute pancreatitis; lumen apposing metal stents (LAMS); proton pump inhibitors (PPI)

Outcome Measures

Primary Outcomes (4)

• Retrospective Cohort Study Primary Outcome Measure Number 1: Association between frequency of LAMS-occlusion and concomitant PPI-intake

  All patients who received a LAMS from the time-point since LAMS have been used at the respective centers will be included. In all patients who received LAMS, their medical records will be checked if a PPI was taken or not. Next, it will be assessed how many patients who took PPIs (PPI-group) had a LAMS-occlusion in comparison with the patients who did not take a PPI (Non-PPI-group). To associate the PPI intake/no PPI intake with LAMS occlusion, we will fit a multiple logistic mixed-effects model including factors potentially affecting the LAMS occlusion rate. As random effects we will include the record identification number and the years of LAMS placement as a surrogate for experience with LAMS.

  Until LAMS-removal, an average of 4 weeks after implantation

• Retrospective Cohort Study Primary Outcome Measure Number 2: Association between frequency of endoscopic necrosectomy and concomitant PPI-intake

  All patients who received a LAMS from the time-point since LAMS have been used at the respective centers will be included. In all patients who received LAMS, their medical records will be checked if a PPI was taken or not. Next, it will be assessed how many necrosectomy sessions were performed in patients who took PPIs (PPI-group) in comparison with the patients who did not take a PPI (Non-PPI-group). To associate the PPI intake/no PPI intake with the number of endoscopic necrosectomy sessions, we will perform a multiple negative binomial mixed-effects model taking into account counfounders such as the year in which a LAMS was placed.

  Until LAMS-removal, an average of 4 weeks after implantation

• Expert Survey Primary Outcome Measure Number 1: Assessment of the clinical relevance of LAMS-occlusion and LAMS-occlusion-related complications

  The expert will be asked if he had experiences with complications after total/partial LAMS-occlusion (yes/no). Moreover, the expert will be asked if he would consider these as frequent complications (yes/no). Next, the expert will be asked how frequent he would consider complications after total/partial LAMS-occlusion to occur (scale 0-20%). Finally, the expert will be asked which complications he had witnessed after total/partial LAMS-occlusion (progression of the pancreatic collection, infection of the WON, sepsis, other).

  Until LAMS-removal, an average of 4 weeks after implantation

• Expert Survey Primary Outcome Measure Number 2: Assessment of the clinical management of LAMS-occlusion in the respective participating centers

  Two clinical cases will be presented. The first case will be suggestive for a total LAMS occlusion with infection/sepsis as a complication consecutive to the stent-occlusion. The second case will be suggestive for a partial LAMS occlusion with no apparent complication. For each case, the expert will be asked if he would consider this a complication (yes/no). Moreover, it will be asked if the expert would remove the LAMS (yes/no), if he would place pigtails over the ostium afterwards (yes/no) and if not what he would do otherwise (endoscopic necrosectomy, place pigtail through the LAMS, disrupted pancreatic duct evaluation via endoscopic retrograde cholangiopancreatography/magnet resonance cholangiopancreatography (ERCP/MRCP), endoscopic papillotomy, other).

  Until LAMS-removal, an average of 4 weeks after implantation

Secondary Outcomes (8)

• Retrospective Cohort Study Secondary Outcome Number 1: Strength of association between PPI intake and the incidence of GI bleeding rates.

  Until LAMS-removal, an average of 4 weeks after implantation

• Retrospective Cohort Study Secondary Outcome Number 2: Strength of association between PPI intake and incidence of WON progression on cross sectional imaging.

  Until LAMS-removal, an average of 4 weeks after implantation

• Retrospective Cohort Study Secondary Outcome Number 3: Strength of association between PPI intake and incidence of superinfection of the WON

  Until LAMS-removal, an average of 4 weeks after implantation

• Retrospective Cohort Study Secondary Outcome Number 4: Strength of association between PPI intake and incidence of sepsis events.

  Until LAMS-removal, an average of 4 weeks after implantation

• Retrospective Cohort Study Secondary Outcome Number 5: Strength of association between PPI intake and length of hospital stay (days).

  Until LAMS-removal, an average of 4 weeks after implantation

Study Arms (2)

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

Drug: Proton pump inhibitor; Device: LAMS-implantation

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

Device: LAMS-implantation

Interventions

Proton pump inhibitor DRUG

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

PPI-group

LAMS-implantation DEVICE

Patients who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis

Non-PPI-group; PPI-group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: gender criteria: male/female/diverse
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients included in the retrospective cohort study will be from private/public non-academic or academic teaching hospitals in Europe. All patients above 18 years of age who received a lumen apposing metal stent (LAMS) for drainage of a walled off necrosis (WON) upon acute pancreatitis will be included. Moreover, the expert survey will be distributed to European experts (gastroenterological interventionalists) from private/public non-academic or academic teaching hospitals with special expertise in pancreatology.

You may qualify if:

• \- Patients in which a Lumen apposing metal stent (LAMS) was applied into a walled off necrosis (WON) as a complication of an acute pancreatitis (AP).

You may not qualify if:

• Patients in which a LAMS was applied into a pseudocyst instead of a WON.
• 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:
• \- European experts (gastroenterological interventionalists) with expertise in pancreatology
• Centers which apply less than 10 LAMS per year
• Centers with less than two years experience with LAMS

Sponsors & Collaborators

• University Medical Center Goettingen: lead
• Technical University of Munich: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• University Hospital in Halle: collaborator
• University of Leipzig: collaborator
• University Hospital Heidelberg: collaborator
• Landesklinikum Sankt Polten: collaborator
• University Hospital, Aachen: collaborator
• University of Oldenburg: collaborator
• University of Newcastle Upon-Tyne: collaborator
• Szeged University: collaborator
• University of Pecs: collaborator
• Semmelweis University: collaborator
• University of Ulm: collaborator
• University Hospital Olomouc: collaborator
• Brno University Hospital: collaborator
• University Hospital Regensburg: collaborator
• Klinikum Stadt Hanau: collaborator
• University Medicine Greifswald: collaborator

Study Sites (1)

University Medical Center Goettingen

Goettigen, Lower Saxony, 37075, Germany

Location

Related Publications (13)

• 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.

  PMID: 23100216 BACKGROUND

• 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.

  PMID: 27449605 BACKGROUND

• 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.

  PMID: 32306430 BACKGROUND

• 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.

  PMID: 33140020 BACKGROUND

• 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.

  PMID: 27825371 BACKGROUND

• 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.

  PMID: 35263780 BACKGROUND

• 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.

  PMID: 26296720 BACKGROUND

• 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.

  PMID: 23242019 BACKGROUND

• 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.

  PMID: 30719997 BACKGROUND

• 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.

  PMID: 17406807 BACKGROUND

• 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.

  PMID: 17122965 BACKGROUND

• 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.

  PMID: 20851132 BACKGROUND

• 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.

  PMID: 40164133 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jacob Hamm

  Department of Gastroenterology, University Hopsital Goettingen

  PRINCIPAL INVESTIGATOR

• Christoph Ammer-Herrmenau, MD

  Department of Gastroenterology, University Hopsital Goettingen

  PRINCIPAL INVESTIGATOR

• Volker Ellenrieder, Professor

  Department of Gastroenterology, University Hopsital Goettingen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 18, 2023
• Study Start: May 5, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

DE (1)