Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

Infection, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555252
• Other study ID #: CHRU NANCY : 2019PI249
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 31, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Locations

Country	Name	City	State
France	Chru Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (8)

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. Epub 2005 Nov 18. — View 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. — View 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. — View Citation

Krüger 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. — View 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. — View 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. — View Citation

Scheufele F, Aichinger L, Jäger 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact of prior biliary drainage on the intraoperative bile microbiological results bacteriological results obtained	bacterial count in log10 bacteria/ml and species identification	from date of initial bile sampling to date of surgery (up to 90 days)
Secondary	Microbial flora in clinical specimens obtained from different sites	bacterial count in log10 bacteria/ml and species identification	from date of initial bile sample up to 90 postoperative days
Secondary	Non infectious surgical complications using scores	Clavien-Dindo Classification, SOFA score	from date of surgery up to 30 postoperative days
Secondary	postoperative infectious complications as defined by the Centers for Disease Control and Prevention (Atlanta, Ga)	number of event occurence	During hospital stay (up to 90 days after surgery)
Secondary	Implication of bacteria found in biliculture as causative agent in post-operative infections	incidence in percentage	During hospital stay (up to 90 days after surg
Secondary	length of stay in intensive care and hospital	Number of days in ICU and hospital	During the ICU stay and hospital
Secondary	mortality rate	number of death at 28 days and 90 days	At day +28 and day +90
Secondary	Description of nutrition assistance	Parenteral, enteral, oral feeding in days and calories	from date of initial bile sample up to 30 days of postoperative period
Secondary	Nutritional status measured by nutritional risk index (NRI)	Body mass index (BMI) and albuminemia computation	preoperative