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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pseudocyst Pancreas Pancreatic Duct Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random control trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Same day

The ERP will be performed the same day of the endoscopic drainage of PP

Group Type ACTIVE_COMPARATOR

Endoscopic retrograde pancreatography

Intervention Type PROCEDURE

Endoscopic cannulation of main pancreatic duct

Other day

The ERP will be performed 6 weeks after the endoscopic drainage of PP.

Group Type ACTIVE_COMPARATOR

Endoscopic retrograde pancreatography

Intervention Type PROCEDURE

Endoscopic cannulation of main pancreatic duct

Interventions

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Endoscopic retrograde pancreatography

Endoscopic cannulation of main pancreatic duct

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No