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Hepatectomy clinical trials

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NCT ID: NCT06166186 Recruiting - Hepatectomy Clinical Trials

Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

Start date: May 22, 2023
Phase: N/A
Study type: Interventional

It has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. It has been reported that music can be used as an alternative non-pharmacological method to reduce pain and anxiety in the perioperative period, as well as surgical stress and the related stress response. The aim of this study is to test the hypothesis that music used as a non-pharmacological method in the intraoperative period can reduce inflammatory response in living donor hepatectomy.

NCT ID: NCT06130436 Recruiting - Liver Cancer Clinical Trials

Application of Perioperative Remote Ischemic Conditioning in Patients Undergoing Hepatectomy

Start date: October 25, 2023
Phase: N/A
Study type: Interventional

Our primary aim is to investigate whether perioperative remote ischemic conditioning (PRIC) as an adjunctive treatment can improve postoperative recovery in patients undergoing hepatectomy as an adjunct to standard treatment.

NCT ID: NCT06044909 Recruiting - Laparoscopy Clinical Trials

Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

IMMORTALLS
Start date: September 15, 2023
Phase:
Study type: Observational

Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. The intraoperative augmentation will also be enriched with the preoperative data (e.g., CT or MRI). This will simplify minimal invasive liver surgery, improve surgical safety and accuracy. It will also shorten hospital stays and contribute to an overall better quality of life for the patient, which in return will reduce the health-care costs.

NCT ID: NCT05598060 Recruiting - Hepatectomy Clinical Trials

Preoperative Stereotactic Body Radiotherapy (SBRT) Followed by Hepatectomy for Centrally Located Hepatocellular Carcinoma: a Prospective, Single-center, Phase I Study

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Hepatocellular carcinoma (HCC) is the sixth prevalent malignancy worldwide. Although surgical excision is considered the standard treatment for resectable HCC, a high rate of postoperative recurrence was observed after partial hepatectomy, with a marginal recurrence rate up to 30%. Narrow margin resection may be the most appropriate procedure for centrally located HCC because the premise for survival is the conservation of more normal liver parenchyma. Unfortunately, narrow margin resection has been reported to contribute to poor survival outcomes. However, no (neo)adjuvant therapy before (or after) hepatectomy is generally considered to be effective in reducing post-operative recurrence. Radiotherapy (RT) has been well used in many solid malignant tumors as an (neo)adjuvant to surgical treatment, including HCC. SBRT has shown encouraging rates of local control for HCC. Compared with standard fractionation radiation, SBRT can achieve more precise delivery of high-dose radiation beams to the lesion, obtaining a much smaller target volume. Meanwhile, it could be finished in a short period which can bring more convenience to patients. Recently, several study and randomized controlled trials revealed the survival benefit of adjuvant RT (IMRT and SBRT) in patients with HCC. However, there are still lack of exploration for the efficacy of neoadjuvant SBRT. This study is to analyze the safety of preoperative SBRT followed by hepatectomy for centrally located hepatocellular carcinoma.

NCT ID: NCT05523713 Recruiting - Hepatectomy Clinical Trials

Development and Validation of a Predictive Score for Surgical Site Infections

SPRED
Start date: October 6, 2022
Phase: Phase 3
Study type: Interventional

More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis. Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University). The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.

NCT ID: NCT05246371 Recruiting - Hepatectomy Clinical Trials

Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury

Start date: June 1, 2021
Phase: Early Phase 1
Study type: Interventional

This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

NCT ID: NCT04705194 Recruiting - Liver Cancer Clinical Trials

Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging

HEPARIM
Start date: July 8, 2019
Phase:
Study type: Observational

Liver resection remains the only curative option for primary or metastatic liver cancer, but a more accurate prediction of post-hepatectomy liver failure (PHLF) is needed to further reduce morbidity and mortality and to extend the indication to a wider patient population. Magnetic resonance Imaging (MRI) is a promising new source of liver function tests as it can provide segmental function alongside measurements of perfusion, tissue structure and standard morphological assessment. The primary aim of HEPARIM is to determine if quantitative MRI biomarkers of liver function and perfusion can improve predictions of post-hepatectomy liver function, as measured by an indocyanine green (ICG) liver function test. Secondary aims is to validate the MRI measurements of liver function against ICG. HEPARIM is an observational cohort study recruiting patients referred locally for a one- or two-stage liver resection of 2 segments or more. Before surgery, all participants will undergo an ICG liver function test and a Dynamic Gadoxetate-enhanced (DGE) MRI scan of the liver. The ICG test will be repeated at one day after surgery. The Gadoxetate Clearance (GC) of the future liver remnant (FLR-GC) will be determined from the DGE-MRI data and correlated to the post-operative ICG R15 as primary outcome measure. Preoperative ICG R15 will be correlated against GC of the whole liver (WL-GC) to address the secondary objective. In patients that undergo a staged hepatectomy, an additional MRI and ICG test will be performed before the first stage to assess its effect on volumetric and functional growth of the FLR. Additional pre- and postoperative data will be collected from medical records including demographics and medical histories, biochemistry, pathology and radiology reports, and any long-term outcome data collected in the 90-day follow-up visit. These data will be used in a multi-variate analysis to determine which preoperative biomarkers are most predictive of immediate and long-term outcomes, to identify the added value of functional MRI over routine clinical markers, and to derive a multi-variate prediction model that can be validated in future studies.

NCT ID: NCT04559269 Recruiting - Hepatectomy Clinical Trials

Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

Start date: October 1, 2019
Phase:
Study type: Observational

During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) < 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

NCT ID: NCT04218253 Recruiting - Liver Neoplasms Clinical Trials

Clinical Application of Nutrition Support Package Before Hepatectomy

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Objective:To confirm the effect of preoperative oral nutrition therapy on patients with malnourished before liver cancer resection. Study design:Prospective, randomized, controlled clinical study. Primary end point: incidence of all complications 30 days after surgery.

NCT ID: NCT03912844 Recruiting - Hepatectomy Clinical Trials

European SIR-Spheres Surgical Registry

ESSURE
Start date: July 25, 2019
Phase:
Study type: Observational [Patient Registry]

Liver resection is the only curative treatment option for primary and secondary liver tumors. For some primary or secondary malignancies (HCC, NET) liver transplantation is a possible treatment option. Unfortunately, the majority of patients show a high hepatic tumor load or adverse intrahepatic distribution, that resection or transplantation at the time of initial diagnosis is not possible. In that case different treatment approaches are possible. For those patients that are very unlikely to ever become resectable, palliative systemic therapy is the preferred treatment option. For those patients that may become resectable after downsizing of the tumors or increase of volume of the future liver remnant secondary resection after induction therapy may be a possibility. Then, an induction treatment that has the most likelihood of causing physical shrinkage of the tumors is usually preferred. One of the approaches to create contralateral hypertrophy to increase future liver remnant is portal vein embolization. However, tumor growth might be stimulated during the phase of hypertrophy. Selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres is an endovascular interventional radio-oncologic procedure treating primary and secondary liver tumors1-3. It offers radiation therapy with yttrium-90, a high-energy beta-emitting isotope, directly in the vascular system of liver tumors. It treats the tumor locally, saves healthy liver tissue and could lead to hypertrophy of this residual healthy liver tissue due to the embolization effect. Therefore secondary liver resection after SIRT might become possible4,5. SIRT could also be an option as bridging-, downsizing- or downstaging-therapy before liver transplantation. Liver resection with local tumor treatment and hypertrophy induction after SIRT seems to be a promising therapy option. Previous reports have shown the feasibility, safety and efficacy of this therapeutic strategy. Aim of the European SIR-Spheres Surgical Registry - ESSURE - is now to further improve the understanding and optimize the process and patient selection of this therapy strategy in its true clinical setting. This registry enables data collection on the real-life clinical application of liver resection/liver transplantation after SIRT.