Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

NCT03525067 | Completed

• 1 other identifier: PSS2016/PERTEK/ELR
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy. The hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.

Conditions

Pancreatic Cancer; Sepsis; Bile Duct Cancer; Duodenal Cancer; Bile Duct; Obliteration; Post-Op Complication; Post-Op Infection; Fistula, Biliary; Fistula; Delayed Gastric Emptying

Outcome Measures

Primary Outcomes (1)

• Postoperative infectious complications at postoperative day 90

  Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.

  Postoperative time until day 90

Secondary Outcomes (3)

• Mortality before ICU discharge

  90 days

• Mortality post operative day 28

  28 days

• Mortality post operative day 90

  90 days

Study Arms (1)

Patients with Bile Samples

Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination.

Other: Bile sampling for bacterial examination

Interventions

Bile sampling for bacterial examination OTHER

At the beginning of pancreaticoduodenectomy, patients had bile sampling from the gallbladder or from the common bile duct for bacterial examination and study of susceptibility to antibiotics.

Patients with Bile Samples

Eligibility Criteria

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

Study Population

Patients over the age of 18, patients underwent programmed pancreaticoduodenectomy for periampullary neoplasms, involving pancreas head adenocarcinoma, malignant ampulloma and intra papillary and mucinous neoplasm

You may qualify if:

• patients over the age of 18
• patients underwent programmed pancreaticoduodenectomy

You may not qualify if:

• Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours)
• Patients had not been taken of a biliary sample in intraoperative period

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, Grand Est, 54035, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Sepsis; Bile Duct Neoplasms; Duodenal Neoplasms; Postoperative Complications; Biliary Fistula; Fistula; Gastroparesis

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Digestive System Fistula; Pathological Conditions, Anatomical; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jean Pierre Pertek, MD

  CHRU Nancy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 15, 2018
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 2, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

FR (1)