No registrations found.
ID
Source
Brief title
Health condition
Chronic pancreatitis (CP).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean Izbicki painscore during follow-up.
Secondary outcome
1. Clinical success: pain relief at end of FU;
2. Complete (Izbicki pain score ¡Ü 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.
Background summary
N/A
Study objective
N/A
Study design
N/A
Intervention
1. Surgical drainage: pancreaticojejunostomy;
2. Endoscopic drainage: ESWL and/or pancreatic stenting.
P.O. Box 22660
Djuna Cahen
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 3474723
Djunacahen@hotmail.com
P.O. Box 22660
Djuna Cahen
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 3474723
Djunacahen@hotmail.com
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL188 |
| NTR-old | NTR225 |
| Other | : N/A |
| ISRCTN | ISRCTN04572410 |
Summary results
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2. N Engl J Med. 2007 Feb 15;356(7):676-84.<br>