Correlation Between Complications After Pancreaticoduodenectomy and Microbiota (COMPAMIC)

Correlation Between Complications After Pancreaticoduodenectomy and Biliary, Pancreatic, Blood, Oral, Intestinal and Fecal Microbiota

Pancreaticoduodenectomy is the most performed pancreatic surgery for malignant or premalignant tumors of the region of the head of the pancreas. Its post-operative morbidity is very high, over 40%. There is very little data on the impact of microbiota on complications after pancreatic surgery. The purpose of this research is to study the correlation between the microbiota (fecal, blood, oral, biliary, pancreatic and intestinal microbiota) and the postoperative complications in patients who undergo pancreaticoduodenectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Other: Microbiota analysis

Detailed Description

After pancreaticoduodenectomy, the post-operative complications can be surgical (pancreatic fistula, gastroparesis) but also infectious, digestive (diarrhea) and lead to malnutrition. They are responsible for prolonged post-operative hospitalizations, impaired quality of life of patients and induce a delay in the implementation of adjuvant chemotherapy, or even an impossibility to achieve it. The absence of adjuvant chemotherapy adversely affects the prognosis of patients, by increasing the rate of recurrence and decreased survival. There is therefore a real oncological benefit in finding solutions to reduce the number and severity of these complications. A change in post-operative microbiota composition has been shown to play a role in the development of post-surgical anastomotic fistulas in colorectal cancer. Despite their importance, there is very little data on the impact of microbiota on complications after pancreatic surgery. We postulate that microbiota variations could have an impact on early and late post-operative complications after pancreaticoduodenectomy. Any patient hospitalized at the Toulouse University Hospital with an indication of a pancreaticoduodenectomy will be offered to participate in this study. Microbiota analysis will be carried out on different samples: blood, stool and saliva samples will be collected during the surgery, between J5 and J10 (post-operative during hospitalization) and at 3 and 6 months after the surgery. Bile, pancreatic and intestinal mucosa samples will only be collected during the surgery. Complications will be collected throughout this study. This study will not create any additional constraints on patient management. The follow-up period will be 6 months. This follow-up period will be fixed for all patients included. The microbiota analyses will be centrally determined during the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient hospitalized at the Toulouse University Hospital with an indication of a pancreaticoduodenectomy
• Patient aged over 18 years old
• Patient having given his written consent
• Patient with social insurance coverage

Exclusion Criteria:

• Patient for whom the pancreaticoduodenectomy was not realized (exploratory laparotomy or other surgery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microbiota analysis; Mircobiota analysis on blood, stool and saliva and bile, pancreatic and intestinal mucosa samples	Other: Microbiota analysis; Microbiota analysis will be carried out on different samples: blood, stool and saliva samples will be collected during the surgery, between 5 and 10 days after surgery and at 3 and 6 months after the surgery. Bile, pancreatic and intestinal mucosa samples will only be collected during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the microbiota	the analysis of the microbiota on the per-operative samples (fecal, blood, oral, biliary, pancreatic and intestinal) in patients undergoing pancreaticoduodenectomy according to the occurrence of early post-operative complications (≤ 90 days)	within 90 days after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Charlotte MAULAT, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; microbiome; microbiota; postoperative complications; Whipple procedure; pancreatic resection
• Other Study ID Numbers: RC31/21/0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No