Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
28/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M A Boermeester

ORCID ID

Contact details

Academic Medical Centre
Departement of Surgery
G4-109.2
P.O. Box 226600
Amsterdam
1100 DD
Netherlands
m.a.boermeester@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR280

Study information

Scientific title

Acronym

SDD-PRO-Whipple Study

Study hypothesis

Peri-operative administration of probiotics or selective decontamination of the digestive tract (SDD) has an effect on small bowel bacterial overgrowth and bacterial translocation to lymph nodes in patients undergoing pylorus preserving pancreaticoduodenectomy (PPPD) by protecting or enhancing bowel (mucosa) permeability.

Ethics approval

Received from the local ethics committee

Study design

Multicentre randomised single-blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Bacterial translocation in pancreaticoduodenectomy

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Intestinal permeability and bacterial translocation following major pancreaticobiliary surgery.

Secondary outcome measures

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

Overall trial start date

01/04/2005

Overall trial end date

01/02/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/04/2005

Recruitment end date

01/02/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Winclove BioIndustries BV (Netherlands)

Sponsor details

Papaverweg 36-B
P.O. Box 37239
Amsterdam
1030 AE
Netherlands

Sponsor type

Industry

Website

http://www.winclove.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes