Clinical trial · Observational
The Role of the Human Microbiome in Patients After Pancreatic Resection.
Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microbial Colonization | — | UNRESOLVED | — |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
| Periampullary Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreatic resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Adult patients with resectable pancreatic or periampullary presumed (pre)malignancy
- interventionNames
- Procedure: Pancreatic resection
Primary outcomes (1)
- measure
- Risk stratification postoperative complications
- timeFrame
- - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
- description
- The primary objective of this study is to classify patients that undergo pancreatic resection into high and low risk groups for postoperative complications, based on saliva, blood, tumor, bile and/or rectal/faecal microbiome profiles.
Secondary outcomes (9)
- measure
- Long time oncological outcomes - site of recurrence
- timeFrame
- - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available