Correlation Between Complications After Pancreaticoduodenectomy and Microbiota

NCT04931069 | Completed

• 1 other identifier: RC31/21/0004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

microbiota; microbiome; pancreaticoduodenectomy; pancreatic resection; Whipple procedure; postoperative complications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Microbiota analysis

EXPERIMENTAL

Mircobiota analysis on blood, stool and saliva and bile, pancreatic and intestinal mucosa samples

Other: Microbiota analysis

Interventions

Microbiota analysis OTHER

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.

Microbiota analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte MAULAT, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: August 6, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)