2015-08
2020-05
2020-05
50
NCT04494282
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
INTERVENTIONAL
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts
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.
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-07-28 | N/A | 2024-03-04 |
2020-07-28 | N/A | 2024-03-06 |
2020-07-31 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Same day The ERP will be performed the same day of the endoscopic drainage of PP | PROCEDURE: Endoscopic retrograde pancreatography
|
| ACTIVE_COMPARATOR: Other day The ERP will be performed 6 weeks after the endoscopic drainage of PP. | PROCEDURE: Endoscopic retrograde pancreatography
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 6 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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