Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05817721
Status:
RECRUITING
Last Update Posted:
2023-05-31
First Post:
2023-03-30
Brief Title:
PROTon Pump Inhibitors and Stent OCclusion Rate Of Lumen Apposing Metal Stents
Sponsor:
University Medical Center Goettingen
Organization:
University Medical Center Goettingen
Study Overview
Official Title:
PROTon Pump Inhibitors and Stent OCclusion Rate Of Lumen Apposing Metal Stents PROTOCOL
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTOCOL
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
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
Detailed Description:
A common complication of acute pancreatitis is the formation of necrosis in 5-10 of all patients which leads to an increased overall mortality of 28 for infected necroses Currently lumen apposing metal stents LAMS are widely used to address necrotic masses LAMS-occlusion is postulated to be a considerable complication However the prevalence clinical impact and management of LAMS-occlusion-related complications remains uncertain Moreover the German guidelines for management of acute pancreatitis do not specify whether a concomitant proton pump inhibitor PPI-therapy should be discontinued or not A recent study suggested a lower rate of LAMS-occlusions but a higher number of required endoscopic necrosectomies upon concomitant PPI-therapy Thus current data are conflicting
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 FisherChi2-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 regressionLASSO will be applied
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 FisherChi2-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 regressionLASSO will be applied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None