bacteria microbiome
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patient with a resectable, borderline resectable or locally advanced pancreatic and periampullary presumed (pre)malignancy. - The intention of the treatment must be curative including surgery and (neo-)adjuvant chemotherapy. - Willing and able to adhere to the study procedures described in this protocol and to grant the study team access to the electronic patient file and other data that are required to answer the research questions described in this protocol.
Exclusion criteria
Exclusion criteria: - Inability to provide adequate informed consent (e.g. language barrier, illiteracy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to classify patients that undergo pancreatic resection into high and low risk groups for postoperative complications (see study protocol 8.3 for definitions), based on longitudinal saliva and/or rectal/faecal microbiome profiles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include, but are not limited to, finding associations between saliva and/or rectal/faecal microbiome profiles and long term oncological outcomes (i.e. site of recurrence, disease free survival, overall survival), complications of neoadjuvant and/or adjuvant chemotherapy, response to neoadjuvant chemotherapy as judged by computed tomography (CT) scan and histological respons, complications associated with bile duct drainage and postoperative endo- and exocrine insufficiency. | — |
Countries
Netherlands
Outcome results
None listed