AzTrials
AzTrials

Infection, BacterialNCT04555252

Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

An observational study of Infection, Bacterial, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection, Bacterial
How many people
70 participants
Where
1 siteFrance
Study dates
1 Feb 2020to 31 May 2021
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: The study will be offered to the patient who has benefited from a cephalic duodenopancreatectomy programmed and hospitalized in CHRU Nancy's ICU

Who may be able to join

  • Age > 18 years
  • Patient operated for a planned cephalic duodenopancreatectomy
  • Post-operative hospitalisation in ICU
  • Information leaflet given to the patient and the support person, with oral information, during the post-operative period

Who cannot join

  • Age < 18 years
  • Emergency duodenopancreatectomy (surgical indication period less than 48 hours)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chru Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study

Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity.

One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice, due to tumoral obstruction of the main bile duct In these cases, it is proposed to perform preoperative bile duct drainage, preferably by endoscopic stenting (ERCP).

Read more

However, several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital..

Thus, the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs,

The study carried out by Cortes et al., based on a control case study design, also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique. In fact, the bacteria isolated during intraoperative bile sampling were similar, in 49% of cases, to those isolated during bacteriological samples collected postoperatively during infectious complications.

The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy.

The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications, to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis.

Keywords
Bile colonization, Cephalic Duodenopancreatectomy
Medical subject headings
Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04555252
Study groupRoleWhat they receive
Cephalic DuodenopancreatectomyPatients who underwent scheduled cephalic duodenopancreatectomy and hospitalized in intensive care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of preoperative Bile and postoperative infection sites microbiology results

    bacterial count in log10 bacteria/ml and identification

    Measured: from date of initial bile sample up to 30 days of postoperative period

Secondary outcomes (9)

  1. Impact of prior biliary drainage on the intraoperative bile microbiological results bacteriological results obtained

    bacterial count in log10 bacteria/ml and species identification

    Measured: from date of initial bile sampling to date of surgery (up to 90 days)

  2. Microbial flora in clinical specimens obtained from different sites

    bacterial count in log10 bacteria/ml and species identification

    Measured: from date of initial bile sample up to 90 postoperative days

  3. Non infectious surgical complications using scores

    Clavien-Dindo Classification, SOFA score

    Measured: from date of surgery up to 30 postoperative days

  4. postoperative infectious complications as defined by the Centers for Disease Control and Prevention (Atlanta, Ga)

    number of event occurence

    Measured: During hospital stay (up to 90 days after surgery)

  5. Implication of bacteria found in biliculture as causative agent in post-operative infections

    incidence in percentage

    Measured: During hospital stay (up to 90 days after surg

  6. length of stay in intensive care and hospital

    Number of days in ICU and hospital

    Measured: During the ICU stay and hospital

  7. mortality rate

    number of death at 28 days and 90 days

    Measured: At day +28 and day +90

  8. Description of nutrition assistance

    Parenteral, enteral, oral feeding in days and calories

    Measured: from date of initial bile sample up to 30 days of postoperative period

  9. Nutritional status measured by nutritional risk index (NRI)

    Body mass index (BMI) and albuminemia computation

    Measured: preoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start1 Feb 2020
  3. Primary completion28 Mar 2021
  4. Study completion31 May 2021

Resources

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555252
Sponsor's protocol ID
CHRU NANCY : 2019PI249
Status last verified
Jul 2020
First submitted
10 Aug 2020
Last updated
12 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ho V, Heslin MJ. Effect of hospital volume and experience on in-hospital mortality for pancreaticoduodenectomy. Ann Surg. 2003 Apr;237(4):509-14. doi: 10.1097/01.SLA.0000059981.13160.97.

    PubMed 12677147

  • DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9. doi: 10.1097/01.sla.0000246856.03918.9a.

    PubMed 17122618

  • Okano K, Hirao T, Unno M, Fujii T, Yoshitomi H, Suzuki S, Satoi S, Takahashi S, Kainuma O, Suzuki Y. Postoperative infectious complications after pancreatic resection. Br J Surg. 2015 Nov;102(12):1551-60. doi: 10.1002/bjs.9919. Epub 2015 Sep 21.

    PubMed 26387569

  • Yu L, Huang Q, Xie F, Lin X, Liu C. Risk factors of postoperative complications of pancreatoduodenectomy. Hepatogastroenterology. 2014 Oct;61(135):2091-5.

    PubMed 25713915

  • Lermite E, Pessaux P, Teyssedou C, Etienne S, Brehant O, Arnaud JP. Effect of preoperative endoscopic biliary drainage on infectious morbidity after pancreatoduodenectomy: a case-control study. Am J Surg. 2008 Apr;195(4):442-6. doi: 10.1016/j.amjsurg.2007.03.016.

    PubMed 18304506

  • Scheufele F, Aichinger L, Jager C, Demir IE, Schorn S, Sargut M, Erkan M, Kleeff J, Friess H, Ceyhan GO. Effect of preoperative biliary drainage on bacterial flora in bile of patients with periampullary cancer. Br J Surg. 2017 Jan;104(2):e182-e188. doi: 10.1002/bjs.10450.

    PubMed 28121036

  • Cortes A, Sauvanet A, Bert F, Janny S, Sockeel P, Kianmanesh R, Ponsot P, Ruszniewski P, Belghiti J. Effect of bile contamination on immediate outcomes after pancreaticoduodenectomy for tumor. J Am Coll Surg. 2006 Jan;202(1):93-9. doi: 10.1016/j.jamcollsurg.2005.09.006. Epub 2005 Nov 18.

    PubMed 16377502

  • Kruger CM, Adam U, Adam T, Kramer A, Heidecke CD, Makowiec F, Riediger H. Bacterobilia in pancreatic surgery-conclusions for perioperative antibiotic prophylaxis. World J Gastroenterol. 2019 Nov 7;25(41):6238-6247. doi: 10.3748/wjg.v25.i41.6238.

    PubMed 31749594

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, Bacterial, 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 4 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 12 Jul 2021. 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?

Comparison of preoperative Bile and postoperative infection sites microbiology results (time frame: from date of initial bile sample up to 30 days of postoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555252, which also lists 8 linked publications.

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 12 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in