Safety and efficacy of preoperative sphincter botulinum toxin injection on postoperative pancreatic fistula after distal pancreatectomy

Not Applicable

• Conditions: K86.8; Other specified diseases of pancreas

• Registration Number: DRKS00007885
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-09
• Study Completion: 2016-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Patients scheduled for elective distal pancreaectomy for various underlying diseases • Age equal or greater than 18 years • Written informed consent

Exclusion Criteria

• Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault) • Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris) • Liver cirrhosis • ASA score > 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• 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 <br>

Secondary Outcome Measures

Name	Time	Method
• 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<br>• Total intensive care unit stay • Postoperative hospital stay<br>