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

Not Applicable

Completed

• Conditions: Pancreatic Duct Disorder; Pseudocyst Pancreas
• Interventions: Procedure: Endoscopic retrograde pancreatography

• Registration Number: NCT04494282
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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).

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Same day	Endoscopic retrograde pancreatography	The ERP will be performed the same day of the endoscopic drainage of PP
Other day	Endoscopic retrograde pancreatography	The ERP will be performed 6 weeks after the endoscopic drainage of PP.

Primary Outcome Measures

Name	Time	Method
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts	6 weeks	Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst