K86.8
Conditions
Interventions
Group 1: Single endoscopic injection of botulinum toxin, reconstituted in 1 mL of isotonic saline, into the intra-duodenal sphincter of Oddi Segment within 7 days before distal pancreatectomy.
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients scheduled for elective distal pancreaectomy for various underlying diseases • Age equal or greater than 18 years • Written informed consent
Exclusion criteria
Exclusion criteria: • Creatinine clearance III • Immunosuppressive therapy • Pregnancy or lactation • Understanding or language problems • Inability to comply with study and/or follow-up procedures • Known allergy or intolerability to botulinum toxin • Any condition which could result in an undue risk for the patient in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Technical feasibility and success of endoscopic botulinum toxin injection in the sphincter of Oddi • Occurrence of postoperative pancreatic fistula (according to the ISGPF definition) within 30 days after the index operation • Intra-abdominal fluid collection or abscess • Re-intervention (re-laparotomy and/or CT-scan and application of drainage system) due to fluid collection, bleeding or fistula | — |
Secondary
| Measure | Time frame |
|---|---|
| • Overall postoperative morbidity (according to the Clavien-Dindo classification) • Delayed gastric emptying and postpancreatectomy hemorrhage (according to the ISGPS definitions) • Postinterventional pancreatitis • 30-day mortality • Perioperative sepsis • Total intensive care unit stay • Postoperative hospital stay | — |
Countries
Germany
Contacts
Public ContactThilo Hackert
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed