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Efficacy of probiotics and selective decontamination of the digestive tract in reducing bacterial translocation in patients with pylorus preserving pancreaticoduodenectomy.


- candidate number1474
- NTR NumberNTR280
- ISRCTNISRCTN71637623
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsN/A 
- Public TitleEfficacy of probiotics and selective decontamination of the digestive tract in reducing bacterial translocation in patients with pylorus preserving pancreaticoduodenectomy.
- Scientific TitleEfficacy of probiotics and selective decontamination of the digestive tract in reducing bacterial translocation in patients with pylorus preserving pancreaticoduodenectomy.
- ACRONYMSDD-PRO-Whipple Study
- hypothesisPerioperative administration of probiotics or SDD has an effect on small bowel bacterial overgrowth and bacterial translocation to lymph nodes in patients undergoing PPPD by protecting or enhancing bowel (mucosa) permeability.
- Healt Condition(s) or Problem(s) studiedPancreas disease
- Inclusion criteria1. Age >18 years;
2. Patients planned for pylorus preserving pancreaticoduodenectomy for suspected malignant or premalignant disease;
3. Informed consent.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2005
- planned closingdate1-feb-2006
- Target number of participants30
- InterventionsGroup A (n=10) will receive probiotics.
Group B (n=10) will receive SDD.
Group C (n=10) will receive standard treatment.
- Primary outcomeIntestinal permeability and bacterial translocation following major pancreaticobiliary surgery.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. M.A. Boermeester
- CONTACT for SCIENTIFIC QUERIESPhD. O. Ruler, van
- Sponsor/Initiator Winclove BioIndustries BV
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryPostoperative infectious complications are mainly caused by the patientís own gut flora. Both the use of enteral probiotics and selective decontamination of the digestive tract (SDD) have been described as succesfull techniques to reduce bacterial translocation and subsequent infectious complications.
- This study aims to quantify the effect of these techniques on the gut flora and the bacterial translocation.
Patients with pylorus preserving pancreaticoduodenectomy (PPPD) are studied because in these patients are a homogeneous group with major surgery may lead to postoperative impaired gastrointestinal motility and bacterial overgrowth.
A total of 30 adult patients who are planned to undergo a pylorus-preserving pancreaticoduodenectomy in the AMC Amsterdam or in the UMC Utrecht.
Preoperatively, excessive cholestasis has been drained, usually by ERCP.
- After informed consent, patients will be randomly assigned to 3 groups.
Group A (n=10) will receive probiotics.
Group B (n=10) will receive SDD.
Group C (n=10) will receive standard treatment.
All patients will receive standardized anesthesia and postoperative analgesia. The effect of preoperative prophylaxis regimes can be assessed by bacterial counts in a small jejunal biopsy and an adjacent lymphnodes.
Also the effect of the prophylactic regimes on gut permeability, cytokine production and faecal flora will be assesed.
- Main changes (audit trail)
- RECORD8-sep-2005 - 4-nov-2008


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