- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2024-05-01
2026-05-01
2026-11-01
200
NCT06381882
St. Antonius Hospital
St. Antonius Hospital
OBSERVATIONAL
The Role of the Human Microbiome in Patients After 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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-02-25 | N/A | 2024-04-19 |
2024-04-19 | N/A | 2024-04-24 |
2024-04-24 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Patients Adult patients with resectable pancreatic or periampullary presumed (pre)malignancy | PROCEDURE: Pancreatic resection
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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). | - (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). | - (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). | - (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. | - (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. | - (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. | - (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. | - (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). | - (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). | - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Robert Verdonk, dr. Phone Number: +088 320 56 00 Email: r.verdonk@antoniusziekenhuis.nl |
Study Contact Backup Name: Kyra Prinsze, drs. Phone Number: +31 6 23 62 95 32 Email: k.prinsze@antoniusziekenhuis.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
