Skip to main content
OpenTrials
Completed

NCT Number: NCT02845258

Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Pseudocyst Cysts Digestive System Diseases Drainage Neoplasms Pancreatic Cyst Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Department GEA, Sahlgrenska university Hospital

Gothenburg, S-413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)

Procedure

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.

Primary outcomes

  1. Short time complication rate

    Time frame: Uo to 48 hours

    The number of EUS-procedure-related complications such as bleeding, infection and death.

  2. 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.

Secondary outcomes

  1. Hospital stay

    Time frame: Up to 30 days

    The number of days spent in hospital post-EUS-drainage

  2. 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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2021
Study completion
2024
First posted
Jul 27, 2016
Registry last updated
Apr 28, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.