Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

Recruiting

• Conditions: Drainage; Pancreatic Pseudocyst

• Registration Number: NCT02845258
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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 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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Primary Completion: 2021-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-28
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short time complication rate	Uo to 48 hours	The number of EUS-procedure-related complications such as bleeding, infection and death.
Repeated drainage frequency	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 Outcome Measures

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

Trial Locations

Locations (1)

Endoscopy Department GEA, Sahlgrenska university Hospital; 🇸🇪 Gothenburg, Sweden