pancreatic necrosis, pre-existent obstructiv cholestasis K85 C25 K86.1 C24.0
Conditions
Interventions
Group 1: 20 patients with pancreatic jejunostomy receive 400mg Moxifloxacin (BAY 12-8039) given either intravenously or orally instead of the antibiotic Ciprofloxacin for 7 days (day 1-7 post surgery)
Sponsors
UNIVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - patients > 18 years of age with proposed elective pancreatic head resection and pancreatic jejunostomy for pancreas carcinoma, lesion of papilla Vateri or duodenum or chronic pancreatitis - previous discharge of bile duct by percutaneous PTD or endoscopic discharge because of indolent icterus. - PPPD or classical 'Kausch-Whipple' surgery - preoperative PTD or ERCP due to obstructive cholestasis - preoperative recanalisation of the portal vein or further vena because of chronic pancreatitis - preoperative application of Somatostatin, Glucagon, Calcitonin, or Aprotinin - reconstruction of the passage by pancreatic jejunostomy and pancreatic duct catheter - available informed-consent
Exclusion criteria
Exclusion criteria: - preoperative chemoradiotherapy - preoperative radiotherapy or chemotherapy - preoperative therapy with corticosteriods up to 1 week before surgery - surgery in anamnesis within one week before surgery (except laparoscopic staging) - preoperative liver cirrhosis Child B or C - impossible operability, intraoperative change of surgical procedure - extension of surgical intervention to liver resection - known incompatibility to Fluorochinolons - ascites and suspicion of spontaneous bacterial peritonitis - pancreatic, peripancreatic sepsis or intra-abdominal infection because of pancreatitis - perforated septic ulcer or traumatic (duodenal) perforation in the upper gastro-intestinal system about 25; - Neutropenia (amount of neutophils 15 mg Prednisone or a Prednisone equivalent per day); - HIV-seropositive patients with CD4-cells <200/microlitre or HIV-seropositive patients, who obtain HAART (Please note: a HIV-test is not required for this described study) - liver cirrhosis in terminal stage (Child-Pugh C) or increase of Transaminases over the 5-fold of the upper standard value - central or peripheral neuropathy (such as epilepsy or psychosis); - clinical appreciable bradykardia - symptomatic cardiac dysrhytmia in anamesis - known congenital or sporadic QTc-extension or treatment von concomitant medication, which prolong the QTc-intervall (such as Cisaprid, anti-arrhythmics of class IA and III as Amiodaron, Sotalol, Disopyramid, Chinidin and Procainamid); - disorders of the electrolyte balance, especially untreated hypokalaemia; - affections of tendons under treatment with Chinolons in anamesis; - previous participation to this study or treatment with study medication within the last 30 days - known or assumed bacterial concomitant infection, with requires an additional systemic treatment - treatment with a systemic (oral or parenteral) antibiotic agent 24 hours before the surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of moxifloxacin in the pancreatic secretion (day1-7 post surgery) and rate of penetration into the pancreatic secretion (concentration in secretion / concentration in tissue) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Occurance of infectious complications - safety and tolerance of the study medication | — |
Countries
Germany
Contacts
Public ContactTobias Keck
UNIVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie
Outcome results
None listed