Clinical trial NCT01683708: Effectiveness Of Symbiotic Therapy In Jaundiced Patients
Official title: Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Infections
Jaundice
Keywords: sepsis
jaundice
symbiotic
translocation
abdominal collection
morbidity
Lead sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Jaundiced patients scheduled for hepato-biliary pancreatic surgery

Brief summary: The aim of the present study was therefore to evaluate if the perioperative administration of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for hepato-biliary and pancreatic surgery.

Detailed description: Despite advances in preoperative patient's selection and anesthetic and surgical techniques, surgery in jaundiced patients is associated with significant morbidity and mortality as a consequence of septic complications. The evidence that nosocomial infections are frequently a consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of the "gut derived sepsis". Indeed, several studies have reported that jaundiced patients present an increased intestinal permeability and consequently a higher rate of bacterial migration from gastrointestinal tract across the lamina propria to local mesenteric lymph nodes and from there to extra-intestinal site. This phenomenon increases after surgical decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced patients is related to different mechanisms such as mucosal atrophy secondary to protracted absence of intraluminal bile that open para-cellular route for bacterial translocation and the decreased clearance capacity of Kuppfer secondary to cholestasis.

The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can improve the mucosal barrier function reducing the bacterial translocation of organism to mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating mucosal immune and non-immune mechanisms through antagonism/competition with potential pathogens.

Eligibility criteria: Inclusion Criteria:

* jaundiced patients scheduled for elective extrahepatic bile duct resections
* age between 18 and 80 year-old Exclusion Criteria:

Exclusion Criteria

* cirrhosis
* American Society of Anesthesiologists (ASA) score 4
* intestinal malabsorption
* emergency surgery
* intolerance to symbiotic
* diagnosis of primary or secondary immunodeficiency
* unresectability

Primary outcomes:
measure: Infectious Morbidity Rate
timeFrame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
Secondary outcomes:
measure: IMMUNE PROFILE
timeFrame: The day before and on postoperative day 7
measure: RATE OF TRANSLOCATION
timeFrame: Intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Mauriziano Hospital, Department of General and Oncological surgery
name: Lorenzo Capussotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14. doi: 10.1097/01.sla.0000219039.20924.88.
citation: Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.