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.

Study Overview

• Status: Recruiting
• Conditions: Drainage; Pancreatic Pseudocyst
• Intervention / Treatment: Procedure: Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Per Hedenström, MD; Phone Number: +46 703 288291; Email: per.hedenstrom@vgregion.se
• Study Contact Backup: Name: Riadh Sadik, Ass prof; Phone Number: +46 733 641355; Email: riadh.sadik@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, S-413 45
    • Recruiting
    • Endoscopy Department GEA, Sahlgrenska university Hospital
    • Contact: Per Hedenström, MD; Phone Number: +46 703 288291; Email: per.hedenstrom@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients >18 years referred to the Sahlgrenska University hospital for the performance of an EUS-guided pancreatic pseudocyst drainage

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Study Director: Riadh Sadik, Ass Prof, Sahlgrenska University Hospital, Gothenburg

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): October 1, 2021
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimated): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst; Pancreatic Pseudocyst
• Other Study ID Numbers: Dnr 573-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO