Clinical trial investigating an endoscopic procedure with the aim to reducethe most frequent and potentially life-threatening complication in patientsundergoing liver resectio

Phase 1

• Conditions: Patients undergoing partial hepatic resection for various underlying diseases.; MedDRA version: 21.1Level: LLTClassification code 10077348Term: Liver resectionSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-006001-35-DE
• Lead Sponsor: niversity Hospital Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-01
• Last Update Posted: 3 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Inclusion Criteria
– Patients scheduled for elective, primary hepatic 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
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 (estimated by Cockcroft-Gault)
– Liver cirrhosis (Child B/C)
– American Society of Anesthesiologists (ASA) score >III
– Hypersensitivity to any BTX 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 BTX 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 BTX application
– 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 clinical trial of medicinal product
• Study Design: Not specified