A prospective randomised trial comparing EUS guided and conventional endoscopic pseudocyst drainage.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24809

Enrollment

Registered

2005-09-12

Start date

2001-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic pseudocysts.

Interventions

1. Endoscopic pseudocyst drainage under direct EUS vision executed by a therapeutic radial echoendoscope

2. Conventional endoscopic pseudocyst drainage using a therapeutic duodenoscope preceded by a diagnostic EUS procedure.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pseudocyst > 5 cm in size; 2. Presence > 6 weeks.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. ASA klass III/IV; 3. Haemorrhagic diathesis; 4. Decompensated liver cirrhosis; 5. Dilated pancreatic duct > 5 mm; 6. Suspected malignancy; 7. Distance between cyst - gut lumen > 1 cm; 8. Multiple septae (indication for surgery).

Design outcomes

Primary

Measure	Time frame
Technical success rate (cyst resolution).	—

Secondary

Measure	Time frame
1. Clinical success rate (symptom relief); 2. Complication rate; 3. Recurrence rate.	—

Contacts

Public ContactDjuna Cahen

Academic Medical Center (AMC), P.O. Box 22660

Djunacahen@hotmail.com+31 (0)20 3474723

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)