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Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery

NCT ID: NCT04189393

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-11-01

Brief Summary

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The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer.

The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of diagnosis until full recovery (three months after surgery).

Detailed Description

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Rationale: The gut microbiome is the composition of micro-organisms that reside in the gastrointestinal tract. Under normal circumstances, the microbiome is balanced and has a beneficial effect on gut function. However, when the microbiome is stressed i.e. by an operation, patients' health or medication, the composition of the microbiome may change rapidly and the virulence of its micro-organisms can increase fast. Surgery, in particular gastrointestinal surgery, has a disruptive effect on the mucosal gut barrier and may lead to shifts in microbial composition. Also, the underlying surgical disease itself can be characterized by changes in the microbiome. Gastrointestinal cancer is associated with specified alterations of the microbiome, and the presence of certain microbiota is related with carcinogenesis and lymph node involvement.

Anastomotic leakage is a severe complication after gastrointestinal surgery and several animal studies linked microbial shifts to the development of anastomotic leakage. Only a few, small and explorative, human studies investigated the microbiome during surgery and correlated their findings with the development of postoperative complications. However, the majority of these studies only sampled the microbiome intraoperatively. Surgery-related microbial shifts manifest also in the pre- and postoperative phase, therefore, sampling in these phases is crucial. To further understand the changes of the microbiome composition due to gastrointestinal surgery and the relation with postoperative infectious complications, samples should be collected on several time points; before, during, and after surgery. With this study we aim to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer in a time frame ranging from the work-up for an operation until the postoperative phase to assess the changing composition of the microbiome during a surgical patient journey.

Conditions

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Gastrointestinal Cancer Colorectal Cancer Pancreatic Cancer Esophageal Cancer Rectum Neoplasm Esophageal Neoplasms Pancreatic Ductal Adenocarcinoma Colonic Neoplasms Gastrointestinal Microbiome Microbiota Anastomotic Leak

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with proven malignancy of the distal esophagus, pancreatic head/corpus, colon or rectum
* Patients undergoing primary elective surgery with construction of an anastomosis of the gastrointestinal tract
* Adult patients above age 18 years
* Written informed consent

Exclusion Criteria

* History of chronic gastro-intestinal disease e.g. Crohns disease and ulcerative colitis
* Presence of acute gastrointestinal infection
* Chronic use of oral antibiotics (3 months or longer)
* Patients undergoing gastrointestinal surgery for gastrointestinal cancer in acute setting
* Patients undergoing construction of an end/loop colostomy or ileostomy (following primary resection)
* Patients undergoing colon and/ or rectal resection without construction of an anastomosis
* Patients who have insufficient knowledge of the Dutch language
* Patients who are not able to give reliable answers to the questionnaires due to a (mental) disease or (cognitive) condition
* Patients who are not able to collect microbiome samples due to a physical or mental condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan AW Bouwense, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center Nijmegen

Martijn WJ Stommel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center Nijmegen

Harry van Goor, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center Nijmegen

Central Contacts

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Melissa NN Arron, MD

Role: CONTACT

Phone: +31243613983

Email: [email protected]

Richard PG ten Broek, MD PhD

Role: CONTACT

Phone: +31243668086

Email: [email protected]

Other Identifiers

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2019-5859

Identifier Type: -

Identifier Source: org_study_id