Clinical trial NCT06381882: The Role of the Human Microbiome in Patients After Pancreatic Resection.
Official title: Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreas Cancer
Pancreas Neoplasm
Pancreas Adenocarcinoma
Periampullary Cancer
Periampullary Carcinoma
Microbial Colonization
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Risk stratification postoperative complications
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Secondary outcomes:
measure: Long time oncological outcomes - site of recurrence
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Long time oncological outcomes - disease free survival
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Long time oncological outcomes - overall survival
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Complications neoadjuvant chemotherapy
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Complications adjuvant chemotherapy
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Response to neoadjuvant chemotherapy
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Complications bile duct drainage
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Postoperative endocrine insufficiency
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
measure: Postoperative exocrine insufficiency
timeFrame: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge
Other outcomes:
Locations:
Study officials:
affiliation: St. Antonius Hospital
name: Robert Verdonk, dr.
role: PRINCIPAL_INVESTIGATOR
References: