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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27733
Enrollment
39
Registered
2005-09-09
Start date
2000-01-01
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

Chronic pancreatitis (CP).

Interventions

1. Surgical drainage: pancreaticojejunostomy
2. Endoscopic drainage: ESWL and/or pancreatic stenting.

Sponsors

None listed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Mean Izbicki painscore during follow-up.

Secondary

MeasureTime frame
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.

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)