Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

NCT04555252 | Completed DMC

• 1 other identifier: CHRU NANCY : 2019PI249
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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). 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.

Conditions

Infection, Bacterial

Keywords

Bile colonization; Cephalic Duodenopancreatectomy

Outcome Measures

Primary Outcomes (1)

• Comparison of preoperative Bile and postoperative infection sites microbiology results

  bacterial count in log10 bacteria/ml and identification

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

Secondary Outcomes (9)

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

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

• Microbial flora in clinical specimens obtained from different sites

  from date of initial bile sample up to 90 postoperative days

• Non infectious surgical complications using scores

  from date of surgery up to 30 postoperative days

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

  During hospital stay (up to 90 days after surgery)

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

  During hospital stay (up to 90 days after surg

Study Arms (1)

Cephalic Duodenopancreatectomy

Patients who underwent scheduled cephalic duodenopancreatectomy and hospitalized in intensive care.

Eligibility Criteria

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

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (8)

• 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.

  PMID: 12677147 BACKGROUND

• 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.

  PMID: 17122618 BACKGROUND

• 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.

  PMID: 26387569 BACKGROUND

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

  PMID: 25713915 BACKGROUND

• 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.

  PMID: 18304506 BACKGROUND

• 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.

  PMID: 28121036 BACKGROUND

• 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.

  PMID: 16377502 BACKGROUND

• 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.

  PMID: 31749594 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• MARIE-REINE LOSSER, MD,PhD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: September 18, 2020
• Study Start: February 1, 2020
• Primary Completion: March 28, 2021
• Study Completion: May 31, 2021
• Last Updated: July 12, 2021

Record last verified: 2020-07

Locations

FR (1)