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

Pancreatic Duct Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04494282
• Other study ID #: INCMNSZ
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 2020

Study information

• Verified date: March 2024
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Duct Disorder
• Pancreatic Pseudocyst
• Pseudocyst Pancreas

Intervention

Procedure:
• Endoscopic retrograde pancreatography
Endoscopic cannulation of main pancreatic duct

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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