Pilot study:Anti-inflammatory effect of stimulation of the intestinal nervous system: a potential new therapy to accelerate gastric emptying
Phase 1
- Conditions
- Patients undergoing pancreaduodenectomy due to benign or malignant tumordrug will be studied for prokinetic or anti-inflammatory effects, because they are known to influence gastrointestinal motilityTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2014-000361-52-BE
- Lead Sponsor
- KULeuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Patients (above 18 years old) undergoing partial or full resection of the pancreas due to benign or malignant tumor
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
Radiotherapy
Outspoken intra-abdominal inflammation (diagnosis= X-ray, labesults)- ‘American Society of Anesthesiologists physical-health status classification’ (ASA-PS) >3
- Uncontrolled diabetes (>200 mg/dl (=11mmol/l))
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether prucalopride has an anti-inflammatory properties<br><br>;Secondary Objective: Not applicable;Primary end point(s): Inflammatoire parameters in blood <br>;Timepoint(s) of evaluation of this end point: Time until discharge
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Clinical symptoms (VAS score)<br>;Timepoint(s) of evaluation of this end point: Time until discharge