MA-PPING: Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery

Sponsor

Radboud University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT04189393

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer Colorectal Cancer Pancreatic Cancer Esophageal Cancer Rectum Neoplasm Esophageal Neoplasms Pancreatic Ductal Adenocarcinoma Colonic Neoplasms Gastrointestinal Microbiome Microbiota Anastomotic Leak

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Outcome Measures

Primary Outcome Measures

Compositional changes of the oral and gut microbiome, assessed by alpha-diversity using 16S rRNA (ribosomal ribonucleic acid) sequencing, described in a surgical patient journey from moment of diagnosis until full recovery [4 months]
Changes of the microbiome composition during the surgical treatment quantified as alpha-diversity by 16S rRNA sequencing. Samples will be collected on 7 moments, starting one month before surgery until three months after surgery.

Secondary Outcome Measures

Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with neo-adjuvant therapy [1 month]
The effect of neo-adjuvant therapy on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with antibiotic prophylaxis [1 week]
The effect of (preoperative) antibiotic prophylaxis on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with bowel preparation [1 week]
The effect of preoperative bowel preparation on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with selective decontamination of the digestive tract (SDD) [1 week]
The effect of selective decontamination of the digestive tract (SDD) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing
Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated to the development of infectious complications (30-day) [1 month]
The effect of infectious complications (such as anastomotic leakage, sepsis, wound infection, pneumonia and urinary tract infection) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Radboud University Medical Center

Investigators

Principal Investigator: Stefan AW Bouwense, MD PhD, Radboud University Medical Center Nijmegen
Principal Investigator: Martijn WJ Stommel, MD PhD, Radboud University Medical Center Nijmegen
Principal Investigator: Harry van Goor, MD PhD, Radboud University Medical Center Nijmegen