Pancreatic CancerNCT03525067
Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
An observational study of Pancreatic Cancer and Sepsis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Sepsis, Bile Duct Cancer
- What is being tested?
- Bile sampling for bacterial examination
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2017to 2 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- patients over the age of 18
- patients underwent programmed pancreaticoduodenectomy
Who cannot join
- Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours)
- Patients had not been taken of a biliary sample in intraoperative period
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. Postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. Infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients.
One of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. In this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ERCP), associated with the placement of a endoprosthesis. However, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. One explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. In addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. This colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. This microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments.
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 in patients who underwent pancreaticoduodenectomy. Patients whit colonized bile and patients with sterile bile were compared for these outcomes.
- Conditions
- Pancreatic Cancer, Sepsis, Bile Duct Cancer, Duodenal Cancer, Bile Duct; Obliteration, Post-Op Complication
- Being tested
- Bile sampling for bacterial examination
- Medical subject headings
- Pancreatic Neoplasms, Sepsis, Bile Duct Neoplasms, Duodenal Neoplasms, Postoperative Complications, Biliary Fistula, Fistula, Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bile sampling for bacterial examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Bile Samples | Patients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination. Receives: Other: Bile sampling for bacterial examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infectious complications at postoperative day 90
Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.
Measured: Postoperative time until day 90
Secondary outcomes (3)
Mortality before ICU discharge
Mortality rate before ICU discharge
Measured: 90 days
Mortality post operative day 28
Mortality rate at post operative day 28
Measured: 28 days
Mortality post operative day 90
Mortality rate at post operative day 90
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Pierre Pertek, MD, Study director, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525067
- Sponsor's protocol ID
- PSS2016/PERTEK/ELR
- Status last verified
- May 2018
- First submitted
- 26 Apr 2018
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies
- ClinicalTrials.gov ID
- NCT03525067
- Acronym / sponsor ID
- PSS2016/PERTEK/ELR
- Conditions
- Pancreatic Cancer, Sepsis, Bile Duct Cancer, Duodenal Cancer, Bile Duct; Obliteration, Post-Op Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreaticoduodenectomy is part of the curative treatment of periampullary neoplasms. Postoperative mortality for this procedure is between 1 and 5 %, and morbidity ranging from 30 to 50%. Infectious complications, with pancreatic fistula and gastric delayed empting, are an important part of this morbidity, affecting nearly 35% of patients.
One of the risk factors of infectious complications is the presence of a preoperative obstructive jaundice, due to obstruction of bile ducts by the tumor. In this case, it is proposed to perform a preoperative drainage of the bile ducts, preferably by endoscopic procedure (ERCP), associated with the placement of a endoprosthesis. However, this procedure is controversial, this one increasing postoperative morbidity, and in particular the rate of infectious complications. One explanation of these events is the bacteriological contamination of the bile ducts during the endoscopic procedure. In addition, it has been observed for the patients who have benefited from preoperative drainage, the biliary flora is predominantly polymicrobial and may contain multiresistant nosocomial germs, unlike patients who have not benefited from this procedure, whose biliary flora is predominantly sterile or monomicrobial. This colonization by multiresistant germs may have consequences in the postoperative period, in fact, up to 49% of the germs found in the bile samples are also found in the samples taken during postoperative infectious events. This microbial release could make it more difficult to take care of postoperative infections, with less efficacy of conventional antibiotic treatments.
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 in patients who underwent pancreaticoduodenectomy. Patients whit colonized bile and patients with sterile bile were compared for these outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Bile Samples | – | Other: Bile sampling for bacterial examinationPatients underwent pancreaticoduodenectomy who had intraoperative bile sampling for bacterial examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patients over the age of 18
- patients underwent programmed pancreaticoduodenectomy
Key exclusion criteria (2 listed)
- Patients underwent emergency pancreaticoduodenectomy (delay less than 48 hours)
- Patients had not been taken of a biliary sample in intraoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bile sampling for bacterial examinationAt 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. | Other | Patients with Bile Samples |
Primary outcome
Postoperative infectious complications at postoperative day 90
Time frame: Postoperative time until day 90
Patients with postoperative infectious complications and compare bacteriological results of samples with bile samples.
3 secondary outcomes
Mortality before ICU discharge
Time frame: 90 days
Mortality post operative day 28
Time frame: 28 days
Mortality post operative day 90
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Pierre Pertek, MD study director
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Sepsis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative infectious complications at postoperative day 90 (time frame: Postoperative time until day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.