DRKS00024061
Recruiting
Phase 2
Randomized controlled trial of PREoperative injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leckage after hepatic resection - PREBOT-II Trial - PRBOT-II
Ruprecht-Karls-University HeidelbergMedical Faculty represented by Universitätsklinikum Heidelberg and its acting Commercial Director Katrin Erk0 sites70 target enrollmentOctober 27, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- bile leakage occuring after hepatic resection
- Sponsor
- Ruprecht-Karls-University HeidelbergMedical Faculty represented by Universitätsklinikum Heidelberg and its acting Commercial Director Katrin Erk
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients scheduled for elective, primary liver 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
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
- •\- Liver cirrhosis
- •\- American Society of Anesthesiologists (ASA) score \>III
- •\- Hypersensitivity to any botulinum toxin 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 botulinum toxin 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 botulinum toxin application and either positive test or missing test for neutralizing antibodies to botulinum toxin
- •\- Understanding or language problems
Outcomes
Primary Outcomes
Not specified
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