Clinical Trial: Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Brief Summary:

Patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. In case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. In modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (EUS). It is not precisely elucidated how this EUS-procedure should be performed in different scenarios. The cyst appearance and the drainage stents and/or technique may impact the clinical outcome.

This study is a prospective, single-center observational study on the outcome after EUS-guided drainage of pancreatic pseudocysts.

Detailed Summary: Patintes referred to Sahlgrenska University hospital for an EUS-guided drainage of a pseudocyst are eligible for inclusion. The drainage is performed at the discretion of an experienced endosonographer. Thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. Intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome:

• Short time complication rate [ Time Frame: Uo to 48 hours ]
  The number of EUS-procedure-related complications such as bleeding, infection and death.
• Repeated drainage frequency [ Time Frame: Up to 3 months ]
  A successful drainage means no need for additional drainage procedures. The need for a repeated drainage is to be regarded as a therapeutic failure. The number of repeated procedures due to the need for additional drainage is recorded.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Hospital stay [ Time Frame: Up to 30 days ]
  The number of days spent in hospital post-EUS-drainage
• Long time complication rate [ Time Frame: Up to 6 months ]
  Infections and other complications related to the non-complete drainage of the pseudocyst after discharge from the hospital

Original Secondary Outcome: Same as current

Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: July 20, 2016
Date Started: January 2006
Date Completion: June 2019
Last Updated: January 24, 2017
Last Verified: January 2017