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

NCT06381882 | Enrolling By Invitation

• 1 other identifier: MiPac
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Long time oncological outcomes - site of recurrence

  - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge

• Long time oncological outcomes - disease free survival

  - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge

• Long time oncological outcomes - overall survival

  - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge

• Complications neoadjuvant chemotherapy

  - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge

• Complications adjuvant chemotherapy

  - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge

Study Arms (1)

Patients

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

Procedure: Pancreatic resection

Interventions

Pancreatic resection PROCEDURE

Any kind of pancreatic resection will be included

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide adequate informed consent (e.g. language barrier, illiteracy)

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Faeces * Rectal swab * Blood (full) * Tumor * Saliva * Bile

MeSH Terms

Conditions

Pancreatic Neoplasms; Communicable Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Verdonk, dr.

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: April 24, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

NL (1)