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Hepatectomy clinical trials

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NCT ID: NCT06237751 Not yet recruiting - Hepatectomy Clinical Trials

Preoperative Sildenafil Administration for Hepatectomy

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

Laparoscopic Hepatectomy (LH) is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. Control Low Central Venous Pressure (CLCVP) technique is currently one of the most important techniques to control intraoperative bleeding. It mainly consists of fluid restriction, position adjustment and use of vasodilators. However, these measures focus on decreasing CVP by reducing the volume of return blood, and less attention is paid to factors such as pulmonary vascular resistance and cardiac function. Sildenafil, known as Viagra, is currently used to treat erectile dysfunction and pulmonary hypertension in men. Its mechanism of action is to inhibit phosphodiesterase-5 (PDE-5) and increase cGMP levels leading to smooth muscle relaxation and vasodilation. Its pharmacological properties provide potential value for the treatment of many diseases. However, few studies have been conducted both domestically and internationally on the use of sildenafil citrate in LH related to CLCVP. The aim of this study is to investigate the following aspects: 1) the feasibility and effectiveness of sildenafil citrate applied to control low central venous pressure in LH, such as intraoperative bleeding, the impact of CVP, and the surgeon's operative field grading to assess the value of its clinical application; 2) the impact of sildenafil citrate applied to the function of the liver and important organs of the kidneys of the patients after LH surgery as well as the incidence of postoperative complications, and to assess the clinical application of its Safety.

NCT ID: NCT05602974 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Adjuvant Stereotactic Body Radiotherapy (SBRT) for Hepatocellular Carcinoma After Hepatectomy With Narrow Margin: a Prospective, Multi-center, Randomized Controlled, Open-labelled, Phase III Study

Start date: March 1, 2023
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 or HCC located near liver capsule 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 adjuvant therapy 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. A large-sample and high-quality multi-center, randomized controlled, prospective study is warranted to further confirm the efficacy of adjuvant radiotherapy in patients with narrow margin resection, considering the small sample size of above-mentioned studies.

NCT ID: NCT03323242 Not yet recruiting - Hepatectomy Clinical Trials

The Use of Technical Vessel Sealing Devices for Recipient Hepatectomy in Liver Transplantation

SEALIVE
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The surgical technique used in liver transplantation has undergone constant Evolution in an effort towards towards a safe, highly standardized procedure. Despite this, the initial step of the recipients' hepatectomy has not been in the focus of clinical research thus far. Due to usually advanced coagulopathy in liver transplantation recipients, this part of the operation still bares the risk of severe hemorrhage. This trial is designed to compare an electrothermic, bipolar vessel sealing device (LigaSureTM) and an ultrasound dissector (HARMONIC ACE®+7) to standard surgical techniques during the recipients' hepatectomy in liver transplantation. In a single center, prospective, randomized, controlled, parallel three armed, confirmatory, open trial, LigaSureTM and HARMONIC ACE®+7 will be compared to standard surgical techniques which, utilize titanium clips and conventional knot tying ligations during the recipients' hepatectomy in liver transplantation. Intraoperative total blood loss is the primary endpoint of the trial. Secondary endpoints include blood loss during the hepatectomy, the duration of both the hepatectomy and the entire surgical procedure, as well as blood transfusion requirements of the procedure. To generate reliable data, intraoperative blood loss will be recorded with respect to all rinse fluids during surgery, ascites and by weighing used swabs to generate reliable data. At 80% power and an alpha of 0.025 for both either of the experimental groups, twenty-three subjects will be analysed per protocol in each study arm in order to detect a clinically relevant reduction of intraoperative blood loss. The intention to treat analysis will include sixty-nine patients. The follow up period for each patient will be 90 days for safety reasons, whereas all clinical outcomes will be measured within the first ten postoperative days. This is the first prospective, randomized trial comparing two innovative, technical methods of vessel sealing and dissection against standard techniques for recipient hepatectomy. This will be done to detect a relevant reduction of intraoperative blood loss during liver transplantation.The results of the trial are expected to improve patients' outcome and safety after liver transplantation and to increase the general safety of this procedure.

NCT ID: NCT02758977 Not yet recruiting - Surgery Clinical Trials

Associating Liver Partition With Portal Vein Ligation for Staged Hepatectomy (ALPPS) vs. Two-Stage Hepatectomy (TSH) for Marginally Resectable Colorectal Liver Metastases (CRLM)

ALPPSforCRLM
Start date: May 2016
Phase: N/A
Study type: Interventional

Surgical resection has offered the best option for prolonged survival in patients with colorectal liver metastases. Limiting factor for major liver resections is the size of the future liver remnant (FLR). In case of normal liver function, 30% of the total liver volume is considered to be sufficient to maintain adequate liver function after resection. In an attempt to further increase "resectability" criteria for patients with too small FLR surgical and interventional maneuvers such as portal vein embolization and portal vein ligation in two-stage hepatectomies have been implemented, but they need an interval of 4-8 weeks to achieve sufficient hypertrophy. In order to obtain adequate but rapid parenchymal hypertrophy a new surgical two-step technique, ALPPS, was introduced for oncological patients requiring extended hepatic resection with limited functional reserve. Both procedures can be performed with acceptable morbidity and mortality. The investigators conclude that it is time to perform a randomized study comparing the two surgical approaches in regard to oncological outcome.