By InvitationNot Applicable

The Role of the Human Microbiome in Patients After Pancreatic Resection.

Netherlands200 participantsStarted 2024-06-01

Plain-language summary

The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles. To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Risk stratification postoperative complications

Timeframe: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge

Trial details

NCT IDNCT06381882

SponsorSt. Antonius Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-01

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