The penetration of moxifloxacin(BAY 12-8039) into the excretory pancreatic secret after intravenous applicatio

Phase 1

• Conditions: pancreatic necrosis, pre-existent obstructiv cholestasis; K85; C25; K86.1; C24.0; Acute pancreatitis; Malignant neoplasm of pancreas; Other chronic pancreatitis; Extrahepatic bile duct

• Registration Number: DRKS00000098
• Lead Sponsor: IVERSITAETSKLINIKUM FREIBURG Allgem.- und Viszeralchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-08
• Study Completion: 2014-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

- 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 <24 hours
- traumatic perforation of the small intestine or colon about <12 hours
- transmural intestinal necrosis due to an acute embolic, thrombotic or mechanical occlusion
- infection, which requires a longer anti-infective treatment as the duration of the medication of the study; patients, who are in need of a antibiotic lavage of the abdominal cavity or the surgical wound
- essential 'open abdominal lavage'
- females with genital (gynaecological) infections
- planned relaparotomy
- known hypersensitivity towards the medication of the study
- pregnancy, lactation period or female, whose a pregnancy can?t excluded
- serious, life-threatening diseases at lifespan less than 48 hours respectively. APACHE-Score >25;
- Neutropenia (amount of neutophils <1000 cells / microlitre) because of cancer or chemotherapy
- known immunosuppressive long-term therapy (included systemic long-term treatment with >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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Occurance of infectious complications<br>- safety and tolerance of the study medication