K86.8
Conditions
Interventions
Group 1: Single endoscopic injection of botulinum toxin in the sphincter of Oddi before distal pancreatectomy
Group 2: No preoperative endoscopic intervention
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial Director
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients scheduled for elective DP, =18 years of age, Ability of subject to understand character and individual consequences of the clinical trial, Written informed consent, For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception for the first 5 days after trial intervention
Exclusion criteria
Exclusion criteria: Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months; congestive heart failure NYHA III/IV, unstable angina pectoris); Renal insufficiency, i.e. creatinine clearance 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 neutralising 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, or participation within the previous 30 days before study enrollment (or longer exclusion period, if required by national or local regulations); Legally incapacitated patients; Patients held in an institution by legal or official order; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically relevant postoperative pancreatic fistula (POPF) and/or death within 30 days after the index operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovarall POPF rate and severity of POPF, Post-interventional pancreatitis, Perioperative sepsis, Delayed gastric emptying (DGE), Post-pancreatectomy hemorrhage (PPH), Intra-abdominal infection/abscess, Lymphatic fistula, Wound infection, Burst abdomen, Re-interventions/-operations, Mortality within 6 months after the index operation, Quality of life (EORTC QLQ C30 und PAN26) after 1 and 6 months, Intensive care unit/intermediate care unit/total hospital stay, Readmission to hospital | — |
Countries
Germany, Italy, United Kingdom
Contacts
Public ContactUlla Klaiber
Universität Heidelberg/University of Heidelberg, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie/Department of General, Visceral and Transplantation Surgery
Outcome results
None listed