Pancreas CancerMiPacNCT06381882
The Role of the Human Microbiome in Patients After Pancreatic Resection.
An observational study of Pancreas Cancer and Pancreas Neoplasm, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Adenocarcinoma
- What is being tested?
- Pancreatic resection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises of adult patients that are presented at the Regional Academic Cancer Center Utrecht (RAKU) with a pancreatic or periampullary presumed (pre)malignancy, where diagnosis must be established at the regional multidisciplinary meeting and the intention of the treatment must be curative.
Who may be able to join
- 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.
Who cannot join
- Inability to provide adequate informed consent (e.g. language barrier, illiteracy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.
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.
Read the detailed description
Rationale:
Resection is the only potentially curative option for pancreatic and periampullary cancer, a complex procedure with a high risk of complications of 30% to 73%. Research shows the presence of altered bacterial populations within fecal, pancreatic fluid, bile and jejunal samples of patients after pancreatic resection compared to healthy samples. Moreover, specific gut microbial composition in the pre- and postoperative period were associated with a higher risk of developing complications after pancreatic resection in small studies. Further research on a larger scale is necessary to validate these findings and to evaluate targeted microbiome modifications to improve outcomes in patients after pancreatic resection.
Objective:
The primary objective of this 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 microbiome profiles.
Study design: Prospective observational cohort study.
Study population: 200 adult patients with resectable pancreatic or periampullary presumed (pre)malignancy.
Main study parameters/endpoints:
The primary endpoint is a composite of postoperative complications including pancreatic fistula, bleeding, gastroenterostomy-, bile- or chyle leakage, delayed gastric emptying, cholangitis, sepsis and organ failure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All participants will be offered the standard of care. In addition, rectal swabs, faeces, salivary, bile, blood and tumor samples will be collected at different time points perioperatively. Participating in this study carries no additional risks.
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Adenocarcinoma, Periampullary Cancer, Periampullary Carcinoma, Microbial Colonization
- Being tested
- Pancreatic resection
- Medical subject headings
- Pancreatic Neoplasms, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic resectionProcedure or surgery
Any kind of pancreatic resection will be included
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adult patients with resectable pancreatic or periampullary presumed (pre)malignancy Receives: Procedure: Pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk stratification postoperative complications
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.
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Secondary outcomes (9)
Long time oncological outcomes - site of recurrence
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and long term oncological outcomes (e.g. site of recurrence).
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Long time oncological outcomes - disease free survival
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and long term oncological outcomes (e.g. disease free survival).
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Long time oncological outcomes - overall survival
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and long term oncological outcomes (e.g. overall survival).
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Complications neoadjuvant chemotherapy
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and complications of neoadjuvant chemotherapy.
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Complications adjuvant chemotherapy
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and complications of adjuvant chemotherapy.
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Response to neoadjuvant chemotherapy
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and response to neoadjuvant chemotherapy as judged by computed tomography (CT) scan and histological respons.
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Complications bile duct drainage
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and complications associated with bile duct drainage.
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Postoperative endocrine insufficiency
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and postoperative endocrine insufficiency (defined as need for new pharmacologic intervention).
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Postoperative exocrine insufficiency
Secondary objectives include, but are not limited to, finding associations between microbiome profiles and postoperative exocrine insufficiency (defined as need for new pharmacologic intervention).
Measured: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Verdonk, St. Antonius Hospital
- Investigators
- Robert Verdonk, dr., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381882
- Sponsor's protocol ID
- MiPac
- Acronym
- MiPac
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD sharing plan is to be discussed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.
- ClinicalTrials.gov ID
- NCT06381882
- Acronym / sponsor ID
- MiPac / MiPac
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Adenocarcinoma, Periampullary Cancer, Periampullary Carcinoma, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale:
Resection is the only potentially curative option for pancreatic and periampullary cancer, a complex procedure with a high risk of complications of 30% to 73%. Research shows the presence of altered bacterial populations within fecal, pancreatic fluid, bile and jejunal samples of patients after pancreatic resection compared to healthy samples. Moreover, specific gut microbial composition in the pre- and postoperative period were associated with a higher risk of developing complications after pancreatic resection in small studies. Further research on a larger scale is necessary to validate these findings and to evaluate targeted microbiome modifications to improve outcomes in patients after pancreatic resection.
Objective:
The primary objective of this 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 microbiome profiles.
Study design: Prospective observational cohort study.
Study population: 200 adult patients with resectable pancreatic or periampullary presumed (pre)malignancy.
Main study parameters/endpoints:
The primary endpoint is a composite of postoperative complications including pancreatic fistula, bleeding, gastroenterostomy-, bile- or chyle leakage, delayed gastric emptying, cholangitis, sepsis and organ failure.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All participants will be offered the standard of care. In addition, rectal swabs, faeces, salivary, bile, blood and tumor samples will be collected at different time points perioperatively. Participating in this study carries no additional risks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Pancreatic resectionAdult patients with resectable pancreatic or periampullary presumed (pre)malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises of adult patients that are presented at the Regional Academic Cancer Center Utrecht (RAKU) with a pancreatic or periampullary presumed (pre)malignancy, where diagnosis must be established at the regional multidisciplinary meeting and the intention of the treatment must be curative.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide adequate informed consent (e.g. language barrier, illiteracy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic resectionAny kind of pancreatic resection will be included | Procedure or surgery | Patients |
Primary outcome
Risk stratification postoperative complications
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
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.
9 secondary outcomes
Long time oncological outcomes - site of recurrence
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Long time oncological outcomes - disease free survival
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Long time oncological outcomes - overall survival
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Complications neoadjuvant chemotherapy
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Complications adjuvant chemotherapy
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Response to neoadjuvant chemotherapy
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Complications bile duct drainage
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Postoperative endocrine insufficiency
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Postoperative exocrine insufficiency
Time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided. The IPD sharing plan is to be discussed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Verdonk, dr. principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Pancreas Neoplasm, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk stratification postoperative complications (time frame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.