Clinical trial investigating an endoscopic procedure with the aim to reduce the most frequent and potentially life-threatening complication in patients undergoing resection of the body and/or tail of the pancreas
- Conditions
- Elective distal pancreatectomy for any underlying diseaseMedDRA version: 21.1Level: LLTClassification code 10013476Term: Distal pancreatectomySystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-002461-35-DE
- Lead Sponsor
- niversity Hospital Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
– Patients scheduled for elective, primary DP (open or
minimally invasive technique)
– 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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 of any Child-Pugh grade
– 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
– Inability to comply with study and/or follow-up procedures
– Pregnancy or lactation
– Concurrent participation in another interventional clinical trial
– Any condition or situation which could result in an undue risk
for the patient and/or influence outcome measures in the
opinion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method