The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts

Study Overview
=================
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).

Official Title
-----------------
The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts

Conditions
-----------------
Pseudocyst Pancreas, Pancreatic Duct Disorder

Intervention / Treatment
-----------------
* Procedure: Endoscopic retrograde pancreatography


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Same day<br>The ERP will be performed the same day of the endoscopic drainage of PP | Procedure: Endoscopic retrograde pancreatography<br>* Endoscopic cannulation of main pancreatic duct<br>|
| Active Comparator: Other day<br>The ERP will be performed 6 weeks after the endoscopic drainage of PP. | Procedure: Endoscopic retrograde pancreatography<br>* Endoscopic cannulation of main pancreatic duct<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic Pseudocyst