Major Hepatectomy and Vascular Clamping

Recruiting

• Conditions: Liver Diseases

• Registration Number: NCT06501742
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

A major hepatectomy consists of the resection of 3 or more liver segments. Its indications are mainly secondary malignant lesions, then primary malignant lesions, benign lesions and septic resections. Around a hundred major hepatectomies are carried out every year in Strasbourg. This surgery is burdened by 4.5% mortality at day 90 and 20 to 50% morbidity. The main intraoperative risks are hemorrhage and hemodynamic instability. Surgical vascular clamping helps reduce the risk of bleeding but is responsible for sometimes major hemodynamic variations, ischemia-reperfusion syndromes and can lead to acute post-operative liver failure. Recent literature attests to the safety of liver resection without vascular clamping, which is why it is less and less practiced.

Different elements are identified as independent risk factors for morbidity and mortality: the presence of cirrhosis, portal embolization, history of renal or cardiac failure, duration of vascular clamping, resected liver volume, transfusion of products labile blood and associated surgical procedures.

Given the significant risk of intra- and post-operative complications, it seems relevant to analyze pre- and intra-operative data in order to highlight risk factors for vascular clamping. This would allow better anticipation of complications, patient information, adaptation of intraoperative monitoring and postoperative surveillance and perhaps a reduction in complications. This study also makes it possible to take stock of the epidemiology around hepatectomies performed at the STRASBOURG University Hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-12
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Major subject (≥ 18 years old)
• Subject operated on for a major hepatectomy at Strasbourg University Hospital during the period from January 1, 2023 to December 31/2023
• Subject who has not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria

• Subject having expressed opposition to participating in the study
• History of liver resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analyze pre- and intra-operative data from a major hepatectomy in order to identify possible predictive factors for intra-operative vascular clamping.	Up to 1 year	Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers (in number) and proportions (in %)of each modality.; The Chi2 test will be used to study the crossover between

Trial Locations

Locations (1)

Service d'Anesthésie - Réanimation Chirurgicale - CHU de Strasbourg - France; 🇫🇷 Strasbourg, France