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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN71637623 |
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Date of registration:
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20/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of probiotics and selective decontamination of the digestive tract in reducing bacterial translocation in patients with pylorus preserving pancreaticoduodenectomy
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Scientific title:
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Date of first enrolment:
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01/04/2005 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN71637623 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised single-blind active controlled parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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M A
Boermeester |
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Address:
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Academic Medical Centre
Departement of Surgery
G4-109.2
P.O. Box 226600
1100 DD
Amsterdam
Netherlands |
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Telephone:
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Email:
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m.a.boermeester@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged greater than 18 years, either sex
2. Patients planned for pylorus preserving pancreaticoduodenectomy for suspected malignant or premalignant disease
3. Informed consent
Exclusion criteria: 1. Antibiotics within a week prior to surgery (peri-operative antibiotics are allowed)
2. Use of other probiotic products 4 weeks before or during the study
3. Non-resectable cancer of the pancreas
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bacterial translocation in pancreaticoduodenectomy
Surgery
Pancreaticoduodenectomy
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Intervention(s)
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After informed consent, patients will be randomly assigned to three groups:
Group A (n = 10): probiotics
Group B (n = 10): selective decontamination of the digestive tract (SDD)
Group C (n = 10): standard treatment
All patients will receive standardised anaesthesia and post-operative analgesia. The effect of pre-operative prophylaxis regimes can be assessed by bacterial counts in a small jejunal biopsy and an adjacent lymph nodes. Also the effect of the prophylactic regimes on gut permeability, cytokine production and faecal flora will be assessed.
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Primary Outcome(s)
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Intestinal permeability and bacterial translocation following major pancreaticobiliary surgery.
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Secondary Outcome(s)
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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 peri-operative treatment versus control treatment
5. Determination of systemic and local inflammatory response due to bacterial translocation after probiotics or SDD
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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