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NCT Number: NCT06501742

Major Hepatectomy and Vascular Clamping

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anesthésie - Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Benjamin LEBAS, MD

CONTACT

[email protected]

33.3.88.12.70.96

Benjamin LEBAS, MD

PRINCIPAL_INVESTIGATOR

Julie GAUDEFROY, MD

SUB_INVESTIGATOR

Lucie HORNECKER, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Analyze pre- and intra-operative data from a major hepatectomy in order to identify possible predictive factors for intra-operative vascular clamping.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin LEBAS, MD

CONTACT

[email protected]

: 33.3.88.12.70.96

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Major Hepatectomy and Vascular Clamping: Pre- and Intra-operative Predictive Factors of Vascular Clamping, Intra- and Post-operative Tolerance

Acronym: HMCV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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