Monocenter, randomized, controlled, open-label, phase-II clinical trial of PREoperative endoscopic injection of BOTulinum toxin in the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy (PREBOTPilot)

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

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 14 days after trial intervention

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 <30 mL/min; Liver cirrhosis of any Child-Pugh grade; American Society of Anaesthesiologists (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 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; 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically relevant postoperative pancreatic fistula (POPF) and/or death within 30 days after the index operation

Secondary Outcome Measures

Name	Time	Method
Overall 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 3 months after the index operation, Quality of life (EORTC QLQ C30 und PAN26) after 1 and 3 months, Intensive care unit/intermediate care unit/total hospital stay, Readmission to hospital