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van CCT (UK)


Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis; a prospective randomised trial.


- candidate number1397
- NTR NumberNTR225
- ISRCTNISRCTN04572410
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleEndoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis; a prospective randomised trial.
- Scientific TitleEndoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis; a prospective randomised trial.
- ACRONYMCEPAN
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedChronic pancreatitis
- Inclusion criteria1. A diagnosis of CP, based on clinical symptoms in combination with morphological changes established by imaging studies (calcifications or ductal changes) and/or pancreatic functional insufficiency;
2. A dominant obstruction of the Pancreatic Duct, demonstrated by presence of a stenosis and/or intraductal stones on MRCP and abdominal CT-scan, located left from the spine, with pre-stenotic ductal dilatation of at least 5 mm;
3. Severe recurrent pancreatic pain with insufficient relieve by non-narcotic analgesics or requiring opiates.
- Exclusion criteria1. Age below 18 or over 80 years;
2. Pancreatic head enlargement > 4 cm;
3. Contra-indication for surgery; ASA class 4, severe portal hypertension;
4. Contra-indications for endoscopy: gastrectomy with Billroth II reconstruction, other pancreatitis related complications (bile duct stricture, pseudocyst) requiring surgery;
5. Previous pancreatic surgery;
6. Suspected pancreatic malignancy;
7. Limited life expectancy (< 2 years);
8. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2000
- planned closingdate1-okt-2004
- Target number of participants39
- Interventions1. Surgical drainage: pancreaticojejunostomy;
2. Endoscopic drainage: ESWL and/or pancreatic stenting.
- Primary outcomeMean Izbicki painscore during follow-up.
- Secondary outcome1. Clinical success: pain relief at end of FU;
2. Complete (Izbicki pain score 10);
3. Partial (>50% decrease, total score > 10);
4. Morbidity and mortality rate;
5. Intervention rate;
6. Hospital stay;
7. Development of endo- and/or exocrine pancreatic insufficiency.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Djuna Cahen
- CONTACT for SCIENTIFIC QUERIESDr. Djuna Cahen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications1. Ned Tijdschr Geneeskd. 2007 Nov 24;151(47):2624-30.;


2. N Engl J Med. 2007 Feb 15;356(7):676-84.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD6-sep-2005 - 16-jun-2008


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