Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Pancreatic Pseudocyst Clinical Trial

Official title:

Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845258
• Other study ID #: Dnr 573-09
• Status: Recruiting
• Start date: January 2006
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Per Hedenström, MD
• Phone: +46 703 288291
• Email: per.hedenstrom[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drainage
• Pancreatic Pseudocyst

Intervention

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.

Locations

Country	Name	City	State
Sweden	Endoscopy Department GEA, Sahlgrenska university Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short time complication rate	The number of EUS-procedure-related complications such as bleeding, infection and death.	Uo to 48 hours
Primary	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	Hospital stay	The number of days spent in hospital post-EUS-drainage	Up to 30 days
Secondary	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