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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06381882
Other study ID # MiPac
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date November 1, 2026

Study information

Verified date April 2024
Source St. Antonius Hospital
Contact Robert Verdonk, dr.
Phone +088 320 56 00
Email r.verdonk@antoniusziekenhuis.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date November 1, 2026
Est. primary completion date May 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Procedure:
Pancreatic resection
Any kind of pancreatic resection will be included

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Antonius Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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