Establishing the role of the human microbiome in patients with a presumed pancreatic or periampullary (pre)malignancy and pancreatic resection.

Conditions: microbiome
10027656
bacteria

Registration Number: NL-OMON56504

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 200

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

- Inability to provide adequate informed consent (e.g. language barrier,
illiteracy)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to classify patients that undergo<br /><br>pancreatic resection into high and low risk groups for postoperative<br /><br>complications (see study protocol 8.3 for definitions), based on longitudinal<br /><br>saliva and/or rectal/faecal microbiome profiles.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives include, but are not limited to, finding associations<br /><br>between saliva and/or rectal/faecal microbiome profiles and long term<br /><br>oncological outcomes (i.e. site of recurrence, disease free survival, overall<br /><br>survival), complications of neoadjuvant and/or adjuvant chemotherapy, response<br /><br>to neoadjuvant chemotherapy as judged by computed tomography (CT) scan and<br /><br>histological respons, complications associated with bile duct drainage and<br /><br>postoperative endo- and exocrine insufficiency. </p><br>