Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

NCT ID: NCT02845258

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2024-06-30

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.

Conditions

Pancreatic Pseudocyst; Drainage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Per Hedenström

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riadh Sadik, Ass Prof

Role: STUDY_DIRECTOR

Sahlgrenska University Hospital, Gothenburg

Locations

Endoscopy Department GEA, Sahlgrenska university Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Per Hedenström, MD

Role: CONTACT

per.hedenstrom@vgregion.se

+46 703 288291

Riadh Sadik, Ass prof

Role: CONTACT

riadh.sadik@vgregion.se

+46 733 641355

Facility Contacts

Per Hedenström, MD

Role: primary

per.hedenstrom@vgregion.se

+46 703 288291

Other Identifiers

Dnr 573-09

Identifier Type: -

Identifier Source: org_study_id