EUCTR2020-006001-35-DE
Active, not recruiting
Phase 1
Randomized controlled trial of PREoperative injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leakage after hepatic resection PREBOT-II - PREBOT-II
niversity Hospital Heidelberg0 sites70 target enrollmentJuly 1, 2021
DrugsBOTOX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital Heidelberg
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •– Patients scheduled for elective, primary hepatic resection with no planned biliary reconstruction
- •– Male or female patients \=18 years of age
- •– Ability of patient to understand character and individual consequences of the clinical trial
- •– Written informed consent (available before enrollment)
- •– For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception until 14 days after trial intervention
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 45
Exclusion Criteria
- •– Patients who already underwent papillotomy for any reason or have an inlaying bile stent
- •– Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
- •– Serious renal insufficiency, i.e. creatinine clearance \<30 mL/min (estimated by Cockcroft\-Gault)
- •– Liver cirrhosis (Child B/C)
- •– American Society of Anesthesiologists (ASA) score \>III
- •– Hypersensitivity to any BTX preparation or to any of the components in the formulation
- •– Neuromuscular disorder, e.g. peripheral motor neuropathic disease, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert\-Eaton syndrome), or any other neurological disorder with associated increased risk for the patient undergoing BTX injection
- •– Any condition in which duodenoscopy and/or the trial intervention is not possible, e.g. for anatomical reasons, or obsolete in the actual situation, e.g. in patients with acute pancreatitis
- •– History of BTX application
- •– Understanding or language problems
Outcomes
Primary Outcomes
Not specified
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