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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
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pseudocyst Pancreas focused on measuring Pancreatic Pseudocyst

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pancreatic pseudocyst that fulfilled the Atlanta Classification
  2. Symptomatic pancreatic pseudocyst
  3. Informed consent obtained

Exclusion Criteria:

  1. Patient unwilling to participate
  2. Absence of duration time of the pancreatography procedure in the record
  3. 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

    First Posted
    July 28, 2020
    Last Updated
    August 10, 2020
    Sponsor
    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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    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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