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

Colorectal Cancer Clinical Trial

— MA-PPING  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04189393
• Other study ID #: 2019-5859
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2019
• Source: Radboud University
• Contact: Melissa NN Arron, MD
• Phone: +31243613983
• Email: melissa.arron[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 months
Secondary	Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with neo-adjuvant therapy	The effect of neo-adjuvant therapy on microbiome composition quantified as beta-diversity by 16S rRNA sequencing	1 month
Secondary	Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with antibiotic prophylaxis	The effect of (preoperative) antibiotic prophylaxis on microbiome composition quantified as beta-diversity by 16S rRNA sequencing	1 week
Secondary	Compositional changes of the oral and gut microbiome, assessed by beta-diversity using 16S rRNA sequencing, correlated with bowel preparation	The effect of preoperative bowel preparation on microbiome composition quantified as beta-diversity by 16S rRNA sequencing	1 week
Secondary	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)	The effect of selective decontamination of the digestive tract (SDD) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing	1 week
Secondary	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)	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	1 month