Pilot study: Anti-inflammatory effect of stimulation of the intestinal nervous system: a potential new therapy to accelerate gastric emptying

Pilot study: Anti-inflammatory effect of preoperative stimulation of the enteric nervous system: a potential new therapeutic intervention to shorten gastroparesis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000361-52-BE

Enrollment

Registered

2014-02-06

Start date

2014-05-15

Completion date

Unknown

Last updated

2024-06-10

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

Conditions

Patients undergoing pancreaduodenectomy due to benign or malignant tumor drug will be studied for prokinetic or anti-inflammatory effects, because they are known to influence gastrointestinal motility

Interventions

Trade Name: Resolor Product Name: Resolor Product Code: M0001 Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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))

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether prucalopride has an anti-inflammatory properties ;Secondary Objective: Not applicable;Primary end point(s): Inflammatoire parameters in blood ;Timepoint(s) of evaluation of this end point: Time until discharge	—

Secondary

Measure	Time frame
Secondary end point(s): Clinical symptoms (VAS score) ;Timepoint(s) of evaluation of this end point: Time until discharge	—

Countries

Belgium

Contacts

Public ContactGuy Boeckxstaens

KULeuven

guy.boeckxstaens@med.kuleuven.be

Outcome results

None listed

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