The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
Primary Purpose
Pseudocyst Pancreas, Pancreatic Duct Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic retrograde pancreatography
Sponsored by
About this trial
This is an interventional treatment trial for Pseudocyst Pancreas focused on measuring Pancreatic Pseudocyst
Eligibility Criteria
Inclusion Criteria:
- Pancreatic pseudocyst that fulfilled the Atlanta Classification
- Symptomatic pancreatic pseudocyst
- Informed consent obtained
Exclusion Criteria:
- Patient unwilling to participate
- Absence of duration time of the pancreatography procedure in the record
- Absence of the number of weeks between the drainage and the pancreatography
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Same day
Other day
Arm Description
The ERP will be performed the same day of the endoscopic drainage of PP
The ERP will be performed 6 weeks after the endoscopic drainage of PP.
Outcomes
Primary Outcome Measures
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts
Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst
Secondary Outcome Measures
Full Information
NCT ID
NCT04494282
First Posted
July 28, 2020
Last Updated
August 10, 2020
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT04494282
Brief Title
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
Official Title
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.
Detailed Description
METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent will be explained and signed. In those patients who ERP fails, a second attempt will be performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance cholangiopancreatography will be performed (Group 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudocyst Pancreas, Pancreatic Duct Disorder
Keywords
Pancreatic Pseudocyst
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random control trial
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Same day
Arm Type
Active Comparator
Arm Description
The ERP will be performed the same day of the endoscopic drainage of PP
Arm Title
Other day
Arm Type
Active Comparator
Arm Description
The ERP will be performed 6 weeks after the endoscopic drainage of PP.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic retrograde pancreatography
Intervention Description
Endoscopic cannulation of main pancreatic duct
Primary Outcome Measure Information:
Title
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts
Description
Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pancreatic pseudocyst that fulfilled the Atlanta Classification
Symptomatic pancreatic pseudocyst
Informed consent obtained
Exclusion Criteria:
Patient unwilling to participate
Absence of duration time of the pancreatography procedure in the record
Absence of the number of weeks between the drainage and the pancreatography
12. IPD Sharing Statement
Learn more about this trial
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
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