Elective distal pancreatectomy for any underlying disease MedDRA version: 21.1 Level: LLT Classification code 10013476 Term: Distal pancreatectomy System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BOTOX
Pharmaceutical Form: Powder for injection
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Sponsors
University Hospital Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – 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
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) – Serious 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the occurrence of clinically relevant POPF (grades B/C) according to the ISGPS and/or death within 30 days after distal pancreatectomy.;Timepoint(s) of evaluation of this end point: The combined primary endpoint is assessed during study visits on postoperative day (POD) 0, POD 3, day of clinical discharge and POD 30.;Main Objective: The main purpose of this study is to evaluate the safety and feasibilty of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi within 3-10 days before distal pancreatectomy to reduce clinically relevant pancreatic fistula (POPF) and/or death, and to gain preliminary efficacy data which will serve as a basis for a subsequent confirmatory trial. The primary endpoint is the occurrence of clinically relevant POPF and/or death due to any cause within 30 days after surgery. Clinically relevant POPF is defined as grade B and C fistulas according to the currently updated definition of the International Study Group of Pancreatic Surgery (ISGPS). Safety is evaluated by the assessment of adverse events (AE) and serious adverse events (SAE). ;Secondary Objective: The secondary objectives are to evaluate postinterventional and postoperative complications in intervention and control groups, i.e. the overall occurrence and severity of postoperative pancreatic Fistula (POPF) according to the International Study Group of Pancreatic Surgery (ISGPS), postinterventional pancreatitis, perioperative sepsis, delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), intraabdominal fluid collection/abscess, lymphatic fistula/chylus ascites, wound infection, burst abdomen, reinterventions/-operations, and overall mortality. Furthermore, quality of life, durations of intensive care unit/intermediate care unit stay and total hospital stay, and readmission due to postoperative complications will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the following: - Overall POPF rate and severity of POPF (i.e. grades B and C, and also biochemical leakage) until POD 30 and within 3 months after the index operation defined according to the currently updated ISGPS definition - Postinterventional pancreatitis - Perioperative sepsis - Delayed gastric emptying (DGE) - Post-pancreatectomy hemorrhage (PPH) - Intraabdominal fluid collection/abscess - Lymphatic fistula/chylus ascites - Wound infection - Burst abdomen - Reinterventions/-operations due to any cause - Mortality - Quality of life - Intensive care unit (ICU)/intermediate care unit (IMC) stay - Total hospital stay - Readmission to hospital for management of postoperative complications For each endpoint, a definition is given in the clinical trial protocol.;Timepoint(s) of evaluation of this end point: Secondary endpoints are assessed during study visits on postoperative day (POD) 3, day of discharge, POD 30 and 3 months after the index operation (distal pancreatectomy). | — |
Countries
Germany
Contacts
Public ContactClinical Project Management
University Hospital Heidelberg, Department of General, Visceral, and Transplantation Surgery
Outcome results
None listed