Acute Pancreatitis Clinical Trial
— PROTOCOLOfficial title:
PROTon Pump Inhibitors and Stent OCclusion Rate Of Lumen Apposing Metal Stents (PROTOCOL)
NCT number | NCT05817721 |
Other study ID # | 2023-02441 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 5, 2023 |
Est. completion date | December 2023 |
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.
Status | Recruiting |
Enrollment | 639 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Retrospective cohort study: Inclusion Criteria: - 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). Exclusion Criteria: - 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: Inclusion Criteria: - European experts (gastroenterological interventionalists) with expertise in pancreatology Exclusion Criteria: - Centers which apply less than 10 LAMS per year - Centers with less than two years experience with LAMS |
Country | Name | City | State |
---|---|---|---|
Austria | University Hospital St. Pölten | St. Pölten | Niederösterreich |
Germany | University Hospital Aachen | Aachen | Northrine Westfalia |
Germany | University Medical Center Goettingen | Goettigen | Lower Saxony |
Germany | University Hospital Halle | Halle | Sachsen-Anhalt |
Germany | Klinikum Hanau | Hanau | Hessen |
Germany | University Hospital Heidelberg | Heidelberg | Baden-Württemberg |
Germany | University Hospital Schleswig-Holstein | Kiel | Schleswig-Holstein |
Germany | University Hospital Leipzig | Leipzig | Sachsen |
Germany | Ludwig Maximilians University | Munich | Bavaria |
Germany | Technical University Munich | Munich | Bavaria |
Germany | University Hospital Regensburg | Regensburg | Bavaria |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Goettingen | Klinikum Stadt Hanau, Landesklinikum Sankt Polten, Ludwig-Maximilians - University of Munich, St. Josef Hospital Bochum, Technical University of Munich, University Hospital Heidelberg, University Hospital in Halle, University Hospital Regensburg, University Hospital Schleswig-Holstein, University Hospital, Aachen, University of Leipzig |
Austria, Germany,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retrospective Cohort Study Primary Outcome Measure: 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 PPI (PPI-group) had a LAMS-occlusion in comparison with the patients who did not take a PPI (Non-PPI-group). | Until LAMS-removal, an average of 4 weeks after implantation | |
Primary | 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 | |
Primary | 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 | Retrospective Cohort Study Secondary Outcome Number 1: Determination of the frequency of LAMS-occlusion-related complications | For every case it will be assess whether ther was a LAMS-occlusion and if this led to a complication (yes/no). Moreover, the type of complication will be assessed (progress of the pancreatic collection, infection of the WON, sepsis, other/unknown). | Until LAMS-removal, an average of 4 weeks after implantation | |
Secondary | Retrospective Cohort Study Secondary Outcome Number 2: Assessment of other risk factor for LAMS-occlusion beyond PPI-intake | For every case, other potential risk factors for LAMS-occlusion will be assessed such as the gender (female, male, diverse), the body mass index (BMI), the type of pancreatitis (acute pancreatitis, recurrent acute pancreatitis, chronic pancreatitis) and the etiology of pancreatitis (biliary, alcohol-induced, idiopathic, iatrogenic, hypercalcemia, hypertriglyceridemia, drugs, traumatic, other/unknown). Moreover, the access way of LAMS-application (transgastric, transduodenal, other/unknown), the type of LAMS used (Hot Axios, Axios, Spaxus, Hot Spaxus, Nagi, Hanaro-Stent, GEN II, other/unknown) and the lumen diameter of the LAMS (e.g. Hot Axios/Axios: 6,8,10,15,20mm, not documented/not assessed) will be assessed. | Until LAMS-removal, an average of 4 weeks after implantation | |
Secondary | Retrospective Cohort Study Secondary Outcome Number 3: Assessment of differences in the clinical management of LAMS-occlusion and LAMS-occlusion-related complications between the participating centers | For each case it will be assessed if a LAMS-occlusion occured after application (yes/no). Moreover, the type of LAMS-occlusion will be assessed (partial LAMS-occlusion, total LAMS-occlusion, unknown/not documented). Next, it will be asked how the occlusion was diagnosed (gastroscopy, endoscopic ultrasound, computer tomography, abdominal ultrasound, other). Moreover, the total number of necrosectomies will be assessed (free text). In addition it will be assessed if the LAMS was removed due to a complication (yes/no, unknown/not documented) and what was done in the following if the LAMS was removed (pigtails were placed over the ostium, another LAMS was applied, surgical procedure, percutaneous drainage, other/unknown). If the LAMS was not removed, it will be asked what else was done in the following (nothing, endoscopic necrosectomy, pigtails were placed through the LAMS, disrupted pancreatic duct evaluation via ERCP/MRCP, endoscopic papillotomy, other/unknown). | Until LAMS-removal, an average of 4 weeks after implantation | |
Secondary | Expert Survey Secondary Outcome Number 1: To assess if a standard operating procedure (SOP) for follow-up-examinations regarding stent occlusion after LAMS-implantation exists in the respective centers. | The expert will basked if a SOP for apparative follow-up-examinations after LAMS application exists at their center (yes/no/unknown). Moreover, it will be asked how many follow up examinations are performed (1, 2, 3 or more), at which time-points (<3 days, within 1 week, 2,3,4,5-8 weeks) and how (CT, MRI, gastroscopy, endoscopic ultrasound, abdominal ultrasound) these are performed. Additionally, it will be asked when the LAMS would be removed normally (=4weeks, 5-8 weeks, =9 weeks after implantation). Moreover, it will be asked which procedure is normally followed after LAMS removal (change LAMS to pigtails, just remove the LAMS, other). | Until LAMS-removal, an average of 4 weeks after implantation | |
Secondary | Expert Survey Secondary Outcome Number 2: To assess whether the respective clinical center has a SOP regarding LAMS and concomitant PPI-intake. | The expert will be asked, if proton pump inhibitors are continued/discontinued upon LAMS-application at his/her center (should be discontinued, should be continued with the same dosage, should be continued with another dosage, currently no standard procedure). If the PPI should be continued in another dosage, it will be asked whether it should be continued in half the standard dose, standard dose, double standard dose or more than standard dose. Moreover, it will be asked if any specific PPI should be discontinued and if yes which of the following (Omeprazole, Esomeprazole, Pantoprazole, Lansoprazole, Rabeprazole). | Until LAMS-removal, an average of 4 weeks after implantation | |
Secondary | Expert Survey Secondary Outcome Number 3: To assess the experts definition of the term "LAMS-occlusion" in general, as well as the term "partial LAMS occlusion". | The expert will be asked which of the following potential causes of LAMS occlusion he/she would include in a universal valid definition for reasons of LAMS-occlusion: tissue ingrowth, tissue overgrowth, food impaction, impaction with liquid necrotic debris, impaction with solid necrotic debris, blood clot formation, stent migration, stent kinking, stent compression, stent fracture, other. Moreover, the expert will be asked how he/she would define partial LAMS-occlusion: An occlusion which is still passable with the endoscope; An occlusion in which you can still see through the LAMS with the optics of the endoscope; An occlusion with liquid parts, other. | Until LAMS-removal, an average of 4 weeks after implantation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05410795 -
Establishment and Verification of Pancreatic Volume Formula Based on Imaging
|
||
Recruiting |
NCT04195347 -
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
|
Phase 1/Phase 2 | |
Completed |
NCT04735055 -
Artificial Intelligence Prediction for the Severity of Acute Pancreatitis
|
||
Completed |
NCT02928718 -
The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
|
||
Terminated |
NCT02885441 -
Treatment of Acute Pancreatitis With Ketorolac
|
Phase 4 | |
Completed |
NCT02563080 -
Pancreatic Exocrine Insufficiency in Acute Pancreatitis
|
||
Recruiting |
NCT01626911 -
Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis
|
N/A | |
Completed |
NCT01507766 -
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
|
Phase 4 | |
Completed |
NCT04901949 -
The Course of Acute Pancreatitis in Patients With Different BMI Groups
|
||
Recruiting |
NCT04814693 -
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
|
N/A | |
Completed |
NCT02743364 -
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
|
Phase 2 | |
Recruiting |
NCT05281458 -
Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections
|
N/A | |
Not yet recruiting |
NCT04990336 -
Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis
|
N/A | |
Not yet recruiting |
NCT03259880 -
Searching the Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals
|
N/A | |
Completed |
NCT02543658 -
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
|
Phase 2 | |
Recruiting |
NCT06023771 -
Invasive Intervention of Local Complications of Acute Pancreatitis
|
||
Not yet recruiting |
NCT05501314 -
Remote Home Monitoring Acute Pancreatitis
|
N/A | |
Completed |
NCT02897206 -
Imipenem Prophylaxis in Patients With Acute Pancreatitis
|
Phase 4 | |
Recruiting |
NCT03634787 -
Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
|
||
Active, not recruiting |
NCT04989166 -
Effect of Nano-curcumin Supplementation in Acute Pancreatitis
|
N/A |