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Forward viewing US endoscope versus standard oblique viewing US endoscope in transmural drainage of pancreatic fluid collections: A randomized controlled trial.


- candidate number4656
- NTR NumberNTR1572
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2008
- Secondary IDsMEC 08/076 
- Public TitleForward viewing US endoscope versus standard oblique viewing US endoscope in transmural drainage of pancreatic fluid collections: A randomized controlled trial.
- Scientific TitleForward viewing US endoscope versus standard oblique viewing US endoscope in transmural drainage of pancreatic fluid collections: A randomized controlled trial.
- ACRONYMForward vs Oblique EUS
- hypothesisObjective: To compare endoscopic pancreatic fluid collection drainage using a standard oblique-viewing US endoscope versus a prototype forward viewing ultrasonic endoscope with emphasis on ease of endoscopic drainage measured by procedural time.
- Healt Condition(s) or Problem(s) studiedPancreatic fluid , Drainage, Endoscopy
- Inclusion criteria1. Presence of a large (> 6 cm) pancreatic fluid collection.
2. Window for endoscopic drainage.
3. Age > 17 years.
4. Written informed consent.
- Exclusion criteria1. Previous surgical or endoscopic drainage.
2. Participation in another intervention trial that would interfere with the intervention and outcome of this study.
3. Transduodenal as the preferred route.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-jan-2008
- planned closingdate12-jan-2009
- Target number of participants52
- InterventionsPatients will be randomly assigned to receive either endoscopic drainage with a forward viewing or standard oblique viewing ultrasonic endoscope.
- Primary outcomeThe primary endpoint will be ease of endoscopic drainage measured by procedural time.
- Secondary outcomeSuccessful drainage procedures, resolution of pancreatic fluid collections, procedure related complications, US endoscope preference according to post-procedural questionnaire.
- TimepointsData are collected by principal investigator or research nurse via a case record form. Patients are observed during their hospital stay. Patients will be followed for a period of 12 months. During this follow up patients will be seen twice on the outpatient clinic (12 weeks and 52 weeks). Abdominal imaging will be performed 10 weeks after last endoscopic drainage procedure. If there is total resolution of the collection is, the stents will be removed.
In case of recurrence of the fluid collection after stent removal or a dilated pancreatic duct (> 5mm) an endoscopic retrograde pancreatogram (ERP) is performed to evaluate the pancreatic duct. If a stricture or fistula is visualized, stenting of the pancreatic duct will be attempted. Follow-up MRI abdominal imaging will be performed 3 months after stent removal.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P. Fockens
- CONTACT for SCIENTIFIC QUERIESDr. P. Fockens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryBackground:
Transmural endoscopic drainage has become treatment of first choice for uncomplicated pancreatic fluid collections.
Drainage is mostly performed with presently available therapeutic oblique-viewing (45) ultrasonic endoscopes.
Puncturing under an angle sometimes hampers successful completion of the procedure because the force that is applied while introducing instruments through the working channel is not fully exerted at the tip of the accessory, but instead drives the endoscope away from the gut wall. A prototype forward viewing ultrasonic endoscope was developed to overcome this difficulty.

Objective:
To compare endoscopic pancreatic fluid collection drainage using a standard oblique-viewing US endoscope versus a prototype forward viewing ultrasonic endoscope with emphasis on ease of endoscopic drainage measured by procedural time.

Study design:
A multicenter randomised controlled, clinical trial.

Study population:
Patients with pancreatic fluid collections in which endoscopic drainage is indicated.

Intervention:
Patients will be randomly assigned to receive either endoscopic drainage with a forward viewing or standard oblique viewing ultrasonic endoscope.

Primary study parameter:
The primary endpoint will be ease of endoscopic drainage measured by procedural time.

Secondary study parameters:
Successful drainage procedures, resolution of pancreatic fluid collections, procedure related complications, US endoscope preference according to post-procedural questionnaire.
- Main changes (audit trail)
- RECORD2-dec-2008 - 10-dec-2008


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