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

NCT ID: NCT06381882

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-11-01

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.

Conditions

Pancreas Cancer; Pancreas Neoplasm; Pancreas Adenocarcinoma; Periampullary Cancer; Periampullary Carcinoma; Microbial Colonization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Adult patients with resectable pancreatic or periampullary presumed (pre)malignancy

Pancreatic resection

Intervention Type: PROCEDURE

Any kind of pancreatic resection will be included

Interventions

Pancreatic resection

Any kind of pancreatic resection will be included

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Antonius Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert Verdonk

dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Verdonk, dr.

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Central Contacts

Robert Verdonk, dr.

Role: CONTACT

r.verdonk@antoniusziekenhuis.nl

+088 320 56 00

Kyra Prinsze, drs.

Role: CONTACT

k.prinsze@antoniusziekenhuis.nl

+31 6 23 62 95 32

Other Identifiers

MiPac

Identifier Type: -

Identifier Source: org_study_id