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van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number1498
- NTR NumberNTR527
- ISRCTNIncomplete data for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleA prospective randomised trial comparing EUS guided and conventional endoscopic pseudocyst drainage.
- Scientific TitleA prospective randomised trial comparing EUS guided and conventional endoscopic pseudocyst drainage.
- ACRONYMDEUS
- hypothesisTo compare Endoscopic ultrasound (EUS) guided pseudocyst drainage to conventional non-EUS guided endoscopic drainage.
- Healt Condition(s) or Problem(s) studiedPancreatic pseudocysts
- Inclusion criteria1. Pseudocyst > 5 cm in size;
2. Presence > 6 weeks.
- Exclusion criteria1. 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).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2001
- planned closingdate31-dec-2006
- Target number of participants40
- Interventions1. 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.
- Primary outcomeTechnical success rate (cyst resolution).
- Secondary outcome1. Clinical success rate (symptom relief);
2. Complication rate;
3. Recurrence rate.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. Djuna Cahen
- CONTACT for SCIENTIFIC QUERIESDr. Djuna Cahen
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD12-sep-2005 - 4-jun-2008


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