Treatment of Pancreatic Pseudocysts by Endoscopic Ultrasound-guided Drainage

NCT02845258 | Completed

• 1 other identifier: Dnr 573-09
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Pseudocyst; Drainage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Hospital stay

  Up to 30 days

• Long time complication rate

  Up to 6 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Endoscopy Department GEA, Sahlgrenska university Hospital

Gothenburg, S-413 45, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pancreatic pseudocyst fluid aspirate for culture and biochemical analysis. No DNA analysis.

MeSH Terms

Conditions

Pancreatic Pseudocyst

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Riadh Sadik, Ass Prof

  Sahlgrenska University Hospital, Gothenburg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: January 1, 2006
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)