Diseases of the pancreas requiring a pyloric preserving pancreaticoduodenectomy.
Conditions
Interventions
Group A (n=10) will receive probiotics.
Group B (n=10) will receive SDD.
Group C (n=10) will receive standard treatment.
Sponsors
Winclove Bio Industries delivers the probiotics.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years; 2. Patients planned for pylorus preserving pancreaticoduodenectomy for suspected malignant or premalignant disease; 3. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Antibiotics within a week prior to surgery (perioperative antibiotics are allowed); 2. Use of other probiotic products 4 weeks before or during the study; 3. Non-resectable cancer of the pancreas.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal permeability and bacterial translocation following major pancreaticobiliary surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of probiotics compared to control treatment on intestinal permeability after major pancreaticobiliary surgery; 2. Effect of probiotics compared to control treatment on bacterial translocation to bowel wall and mesenteric lymph nodes; 3. Comparison of probiotics to SDD on parameters of intestinal permeability and bacterial translocation; 4. Determination of intestinal bacterial overgrowth after probiotics or SDD perioperative treatment versus control treatment; 5. Determination of systemic and local inflammatory response due to bacterial translocation after probiotics or SDD. | — |
Contacts
Public ContactM.A. Boermeester
Academic Medical Center (AMC), Departement of Surgery, G4-109.2, P.O. Box 226600
Outcome results
None listed