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. 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

Intervention / Treatment

• Drug: Proton pump inhibitor
• Device: LAMS-implantation

Primary Outcome Measures

• Retrospective Cohort Study Primary Outcome Measure: Association between frequency of LAMS-occlusion and concomitant PPI-intake (Until LAMS-removal, an average of 4 weeks after implantation)
  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 PPI (PPI-group) had a LAMS-occlusion in comparison with the patients who did not take a PPI (Non-PPI-group).
• Expert Survey Primary Outcome Measure Number 1: Assessment of the clinical relevance of LAMS-occlusion and LAMS-occlusion-related complications (Until LAMS-removal, an average of 4 weeks after implantation)
  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).
• Expert Survey Primary Outcome Measure Number 2: Assessment of the clinical management of LAMS-occlusion in the respective participating centers (Until LAMS-removal, an average of 4 weeks after implantation)
  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).

Countries

Austria, Germany

Locations and Investigators

• University Hospital St. Pölten, St. Pölten, Austria (Not yet recruiting)
  • Emanuel Steiner, MD
• University Hospital Heidelberg, Heidelberg, Germany (Not yet recruiting)
  • Ana Dugic, MD
• Ludwig Maximilians University, Munich, Germany (Recruiting)
  • Simon Sirtl, MD
• Technical University Munich, Munich, Germany (Recruiting)
  • Veit Philip, MD
• University Hospital Regensburg, Regensburg, Germany (Not yet recruiting)
  • Sophie Schlosser-Hupf, MD
• Klinikum Hanau, Hanau, Germany (Not yet recruiting)
  • Lukas Welsch, MD
• University Medical Center Goettingen, Goettigen, Germany (Recruiting)
  • Jacob Hamm
  • Christoph Ammer-Herrmenau, MD
• University Hospital Aachen, Aachen, Germany (Not yet recruiting)
  • Karim Hamesch, MD
• University Hospital Halle, Halle, Germany (Not yet recruiting)
  • Julian Cardinal von Widdern, MD
• University Hospital Leipzig, Leipzig, Germany (Not yet recruiting)
  • Albrecht Hoffmeister, MD
• University Hospital Schleswig-Holstein, Kiel, Germany (Not yet recruiting)
  • Mark Ellrichmann, MD

Study Officials

• Jacob Hamm (Principal Investigator) — Department of Gastroenterology, University Hopsital Goettingen
• Christoph Ammer-Herrmenau, MD (Principal Investigator) — Department of Gastroenterology, University Hopsital Goettingen
• Volker Ellenrieder, Professor (Study Chair) — Department of Gastroenterology, University Hopsital Goettingen