Clinical trial NCT04555252: Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy
Official title: Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Bacterial
Keywords: Bile colonization
Cephalic Duodenopancreatectomy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison of preoperative Bile and postoperative infection sites microbiology results
timeFrame: from date of initial bile sample up to 30 days of postoperative period
Secondary outcomes:
measure: Impact of prior biliary drainage on the intraoperative bile microbiological results bacteriological results obtained
timeFrame: from date of initial bile sampling to date of surgery (up to 90 days)
measure: Microbial flora in clinical specimens obtained from different sites
timeFrame: from date of initial bile sample up to 90 postoperative days
measure: Non infectious surgical complications using scores
timeFrame: from date of surgery up to 30 postoperative days
measure: postoperative infectious complications as defined by the Centers for Disease Control and Prevention (Atlanta, Ga)
timeFrame: During hospital stay (up to 90 days after surgery)
measure: Implication of bacteria found in biliculture as causative agent in post-operative infections
timeFrame: During hospital stay (up to 90 days after surg
measure: length of stay in intensive care and hospital
timeFrame: During the ICU stay and hospital
measure: mortality rate
timeFrame: At day +28 and day +90
measure: Description of nutrition assistance
timeFrame: from date of initial bile sample up to 30 days of postoperative period
measure: Nutritional status measured by nutritional risk index (NRI)
timeFrame: preoperative
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Chru Nancy
Study officials:
affiliation: CHRU Nancy
name: MARIE-REINE LOSSER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Yu L, Huang Q, Xie F, Lin X, Liu C. Risk factors of postoperative complications of pancreatoduodenectomy. Hepatogastroenterology. 2014 Oct;61(135):2091-5.
citation: 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.
citation: 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.
citation: 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.
citation: 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.