Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501742
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Major Hepatectomy and Vascular Clamping
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Major Hepatectomy and Vascular Clamping Pre- and Intra-operative Predictive Factors of Vascular Clamping Intra- and Post-operative Tolerance
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HMCV
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 45 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None