Randomized controlled trial of PREoperative injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leckage after hepatic resection - PREBOT-II Trial

Phase 2

Recruiting

• Conditions: bile leakage occuring after hepatic resection; K83.3; K83.2; Fistula of bile duct; Perforation of bile duct

• Registration Number: DRKS00024061
• Lead Sponsor: Ruprecht-Karls-University HeidelbergMedical Faculty represented by Universitätsklinikum Heidelberg and its acting Commercial Director Katrin Erk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients scheduled for elective, primary liver resection with no planned biliary reconstruction
- 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

Exclusion Criteria

- Patients who already underwent papillotomy for any reason or have an inlaying bile stent
-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 <30 mL/min
- Liver cirrhosis
- American Society of Anesthesiologists (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 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of postoperative bile leakage within 30 days after hepatic resection according to the International Study Group of Liver Surgery (ISGLS)

Secondary Outcome Measures

Name	Time	Method
Severity of bile leakage according to the ISGLS, occurrence of post-interventional pancreatitis, post-hepatectomy liver failure according to the ISGLS, postoperative overall morbidity ( including post-hepatectomy hemorrhage according to the ISGLS, intra-abdominal fluid collection/abscess, perioperative sepsis, etc.) and severity of listed postoperative complications according to the Clavien-Dindo classification, reinterventions/-operations, mortality, quality of life using the Short Form (SF)-12 Health Survey, intensive/intermediate care unit stay, total hospital stay, readmission to hospital