Набор по приглашению NCT06381882

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

— Наблюдательное Pancreas Cancer Pancreas Neoplasm Pancreas Adenocarcinoma Periampullary Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Pancreatic resection.
Кому может быть актуально: Состояния в реестре: Pancreas Cancer, Pancreas Neoplasm, Pancreas Adenocarcinoma, Periampullary Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Establishing the Role of the Human Microbiome in Patients With a Presumed Pancreatic or Periampullary (Pre)Malignancy and Pancreatic Resection.

Обзор

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.

Подробное описание

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.

Вмешательства

Процедура Pancreatic resection
Any kind of pancreatic resection will be included

Первичные конечные точки

Risk stratification postoperative complications [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]

Вторичные конечные точки (9)

Long time oncological outcomes - site of recurrence [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Long time oncological outcomes - disease free survival [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Long time oncological outcomes - overall survival [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Complications neoadjuvant chemotherapy [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Complications adjuvant chemotherapy [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Response to neoadjuvant chemotherapy [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Complications bile duct drainage [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Postoperative endocrine insufficiency [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]
Postoperative exocrine insufficiency [Срок оценки: - (Before start chemotherapy), peroperative, preoperative, postoperative day 1/3, +/- 2 weeks post-discharge]

Критерии участия

Критерии включения

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.