Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Pancreatic Pseudocyst, Drainage

Intervention / Treatment
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* Procedure: Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage Exclusion Criteria: Patients unwilling to participate or unable to understand or sign the informed consent Patients with no need for pseudocyst drainage as assessed by the endosonographer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)|Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS): This procedure is to be regarded as a clinical routine procedure since a couple of years back. The type of stent (material? length? thickness?), the cyst appearance (large? infected? cyst wall thickness?) and the type of access (transgastric? transduodenal?) may however vary from patient to patient. In this study we perform EUS-drainage using different types of equipment on a wide range of pancreatic pseudocysts of different appearance and character. All procedures are performed as recommended. The very aim of the study is to investigate which technique and Equipment is to be preferred in different scenarios.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short time complication rate | The number of EUS-procedure-related complications such as bleeding, infection and death. | Uo to 48 hours | 
| Repeated drainage frequency | 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. | Up to 3 months | 

Secondary Outcome Measures

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