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OpenTrials
Completed

NCT Number: NCT04494282

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

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic retrograde pancreatography

Procedure

Endoscopic cannulation of main pancreatic duct

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 31, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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