Role of Lanreotide in the Management of Paraduodenal Pancreatitis - LPP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016082-29-BE

Enrollment

Registered

2009-11-25

Start date

2010-03-10

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Paraduodenal pancreatitis MedDRA version: 12.1 Level: LLT Classification code 10009093 Term: Chronic pancreatitis

Interventions

Trade Name: Somatuline Autogel 90 mg Pharmaceutical Form: Solution for injection CAS Number: 127984741 Other descriptive name: LANREOTIDE ACETATE Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with one or several of the following radiological criteria for paraduodenal pancreatitis will be selected to participate to the protocol: an occupying mass lesion in the pancreaticoduodenal groove (hypointense relative to the pancreatic tissue on T1-weighted images and iso or slightly hyperintense on T2-weighted images); duodenal-wall thickening; cysts in the groove or/and duodenal wall.8 Others inclusion criteria will be being 18 years or older and having the capacity to give an informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria will include a current pregnancy and the evidence of neoplasia (digestive or other).

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The aim of this study is to evaluate the efficacy of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis by radiological and clinical evaluation after 3 months The aim of this study is to evaluate the safety of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis ;Primary end point(s): Primary endpoint will be the radiological response (evaluated by magnetic resonance imaging) after 6 months of treatment and will be defined as any reduction of the duodenal-wall thickening, a reduction of >50% in the cyst size or the cyst number, and/or a reduction of >50% in the diameter of the biliary and/or the pancreatic ducts. ;Main Objective: The aim of this study is to evaluate the efficacy of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis by radiological and clinical evaluation after 6 months	—

Measure

Time frame

Secondary Objective: The aim of this study is to evaluate the efficacy of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis by radiological and clinical evaluation after 3 months The aim of this study is to evaluate the safety of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis ;Primary end point(s): Primary endpoint will be the radiological response (evaluated by magnetic resonance imaging) after 6 months of treatment and will be defined as any reduction of the duodenal-wall thickening, a reduction of >50% in the cyst size or the cyst number, and/or a reduction of >50% in the diameter of the biliary and/or the pancreatic ducts. ;Main Objective: The aim of this study is to evaluate the efficacy of lanreotide 90 mg compared to placebo in the management of paraduodenal pancreatitis by radiological and clinical evaluation after 6 months

—

Countries

Belgium

Outcome results

None listed

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