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Clinical Trials/NCT04494282
NCT04494282CompletedNot Applicable

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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran0 sites50 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Primary Endpoint
The 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Same day

Active Comparator

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

Intervention: Endoscopic retrograde pancreatography (Procedure)

Other day

Active Comparator

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

Intervention: Endoscopic retrograde pancreatography (Procedure)

Outcomes

Primary Outcomes

The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts

Time Frame: 6 weeks

Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angela Saúl

Principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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