Prospective, randomised, single-blind study for validation of the effect of endoscopic stent implantation and drainage on patients with chronic pancreatitis and pancreas duct stenosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13044540

Enrollment

Registered

2005-10-21

Start date

2004-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pancreatitis with pancreatic duct stenosis Digestive System Pancreatitis

Interventions

Endoscopic stenting of the pancreatic duct, stent exchange after 3 months versus conservative treatment with analgesics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic pancreatitis with evidence of magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) pancreatic duct stricture (>50%) in pancreatic head 2. Chronic recurrent pain 3. Age >18, <75, WIC

Exclusion criteria

Exclusion criteria: 1. Radiation of upper abdominal or lower chest area 2. Uncured cancer or systemic chemotherapy within last 5 years 3. Failure of compliance 4. Foreseeable pregnancy 5. Participation in other therapeutic trials within last 30 days 6. Patients continuous free of symptoms

Design outcomes

Primary

Measure	Time frame
Total pain score during first 3 month after ERCP, specialised Pancreas Pain Questionaire checked for reliability and validity	—

Secondary

Measure	Time frame
1. Use af analgesics 2. Frequency of pain episodes within one year 3. Treatment failure 4. Signs of endocrine/exocrine failure 5. Change of diameter of pancreatic duct during treatment	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026