Clinical Research Directory

Routine Intraoperative White Test for Bile Leak Detection in Liver Resection: A Randomized Trial Protocol

Bile leakage (BL) remains one of the most frequent complications following liver resection and is associated with increased postoperative morbidity and mortality, higher reintervention rates, prolonged hospital stay, and increased healthcare costs. Effective intraoperative identification and closure of open bile ducts may reduce the risk of postoperative BL. The White Test, which involves retrograde injection of a lipid emulsion into the biliary tree, enables active detection of bile leaks during surgery; however, its routine use has not been established in randomized clinical trials across all types of liver resection. This is a single-center, prospective, randomized, parallel-group, single-blinded superiority trial designed to evaluate the effectiveness of routine intraoperative use of the White Test compared with standard intraoperative bile leak detection using a white gauze test. Adult patients undergoing elective liver resection (major or minor, including both anatomic and non-anatomic resections) who meet eligibility criteria will be enrolled after providing written informed consent. Participants will be randomized in a 1:1 ratio to either the intervention group (White Test) or the control group (standard gauze test), using stratified block randomization according to the type of resection (major vs minor). Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Patients will remain blinded to group assignment, while the operating surgeon cannot be blinded due to the nature of the intervention. In the intervention group, following completion of liver parenchymal transection and achievement of hemostasis, the cystic duct stump will be identified and cannulated. The distal bile duct will be temporarily occluded, and 10-20 mL of lipid emulsion will be injected retrogradely into the biliary tree. The transection surface will be inspected for leakage of the white emulsion. Identified leaks will be managed by ligation or suturing, and the test may be repeated until no further leakage is observed. In the control group, bile leak detection will be performed by applying sterile white gauze to the transection surface with visual inspection, followed by suturing of identified leaks as needed. All patients will have intra-abdominal drainage placed at the resection site. Drain fluid bilirubin concentration will be measured on postoperative day three. Patients will be followed for 30 days after surgery. The primary outcome is the incidence of postoperative bile leakage within 30 days, defined according to the International Study Group of Liver Surgery (ISGLS) criteria. Secondary outcomes include severity of bile leakage (ISGLS grades A-C), postoperative morbidity (Clavien-Dindo classification), need for postoperative interventions (endoscopic, radiological, or surgical), intensive care unit (ICU) admission and length of ICU stay, and total hospital length of stay. The primary analysis will follow the intention-to-treat principle and will be performed separately within strata defined by resection type (major vs minor). Secondary and subgroup analyses will be considered exploratory. No formal interim analysis is planned; however, patient safety will be continuously monitored throughout the study. The results of this trial are expected to clarify the role of routine intraoperative White Test in liver surgery and its potential to reduce postoperative bile leakage and improve clinical outcomes.

A Study of Methylprednisolone in People Having Liver Surgery

The purpose of this study is to test whether receiving methylprednisolone before surgery will reduce the side effects of having surgery, such as infections and longer hospital stays.

Spinal Anesthesia For Enhanced Recovery After Liver Surgery

This project proposes to compare epidural versus spinal anesthesia in patients having liver resection surgery. The investigators hypothesize that spinal anesthesia will result in improved blood pressure control postoperatively and reduce the amount of intravenous fluids required after surgery. Spinal anesthesia is expected to provide the same pain control benefits as epidurals, with faster recovery of function. Spinal anesthesia may be a simple and effective way to improve and enhance the recovery in the increasing number of patients requiring liver resection.

The Use of Artificial Intelligence for the Prediction of Recurrence After Resection of Colorectal Liver Metastases

Colorectal cancer is the third most common cancer worldwide and the fourth most common cause of cancer-related death. Survival is primarily determined by stage of disease and the presence of metastases. The combination of chemotherapy and liver resection remains the treatment option with the highest survival benefit for patients with liver metastases from colorectal cancer, with surgery still being the only recognized potential curative treatment; surgical locoregional treatment can also be combined with thermal ablation to enhance the possibility of complete liver clearance. Despite significant improvements in prognosis, a large proportion of patients (almost half) will still experience recurrence following treatment. There is a clinical need to identify a priori patients who are different likely to develop disease recurrence after locoregional treatment (liver resection ± thermal ablation) and to respond differently to chemotherapy, in order to refine risk-based allocation of treatments and resources. Widespread digitalization of healthcare generates a large amount of data, and together with today accessible high-performance computing, artificial intelligence technologies can be applied to overcome the current limitations in estimating colorectal cancer liver metastases recurrence and response to locoregional and chemotherapy treatments, thus achieving better treatment allocation than current practice. All radiomic features can also help in training the neural network aimed at detecting liver metastases before they become visually detectable by the radiologist. Therefore, this study aims to evaluate whether a multifactorial machine learning model (including clinical and radiomic) can identify patients with colorectal cancer liver metastases with a high risk of progression after chemotherapy and recurrence after liver resection

Clinical Trial Protocol for Evaluating the Efficacy and Safety of Thoracoabdominal Endoscopic Surgery System in Remote Laparoscopic Surgery for Urology, General Surgery, Gynecology and Thoracic Surgery

Evaluation of the Efficacy and Safety of the Thoracoabdominal Endoscopic Surgery System Produced by Shenzhen Cornerstone Robotics Technology Co., Ltd. in Remote Laparoscopic Surgeries for Urology, General Surgery, Gynecology and Thoracic Surgery

Ultrasound Guided External Oblique Intercostal Plane Block Versus Erector Spinae Block for Post Hepatectomy Pain

Management of acute post-operative pain has received keen attention in recent years with considerable concurrent advancement in the field. The importance of effective pain relief has long been realised, and acute pain services (APS) are operational in majority of the hospitals in the developed world for decades. Postoperative pain following abdominal surgery if severe enough may cause several side effects as "splinting, hypoventilation, atelectasis, immobility, hypercoagulability, thromboembolic events, vasoconstriction, tachycardia, increased systemic vascular resistance, dysrhythmias and cardiac ischemia in susceptible patients, insomnia, anxiety, feeling of helplessness". Ultrasound-guided fascial plane blocks have been rapidly incorporated into regional anaesthesia practice in recent years as an alternative to neuraxial techniques and involve injection into a tissue plane to provide analgesia in various anatomic areas. External oblique intercostal plane block (EOIPB) is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. The erector spinae plane (ESP) block is a new regional aesthetic technique that can be used to provide analgesia for a variety of surgical procedures or to manage acute or chronic pain. The technique is relatively easy to perform on patients. The ESPB involves injection of local anaesthetic in the erector spinae fascial plane, superficial to the tip of the transverse process of the vertebra and deep to the erector spinae muscle.

AI-Based Prediction of HCC Recurrence Patterns After Resection (APAR)

This observational study aims to validate a deep learning model for predicting aggressive recurrence patterns in patients with early-stage liver cancer (HCC) after surgery. The main question it aims to answer is: Can the AI model accurately identify patients at high risk of cancer recurrence within 2 years after surgery? Participants will provide clinical data and undergo standard surgery, followed by 2-year imaging surveillance. Their data will be used for both AI prediction and validation of recurrence patterns.

Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections

Major liver resection is associated with substantial intraoperative blood loss and subsequently blood transfusions. Blood transfusion in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection and thus reduced blood transfusion in major liver surgeries.

Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy

The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by: Primary Objective: Primary outcome measure: ● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours Secondary outcome measure: * Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge * Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow. * Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours * Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU) Hypothesis: The investigators hypothesize that the application of ITPB targeting the retro-SCTL space in patients undergoing open hepatectomy will improve overall quality of recovery and pain score.

Textbook Outcomes of Right Hemihepatectomy in Patients With Hepatocellular Carcinoma

Although traditional open right hemihepatectomy is a mature technique, the incision is usually very large; Intraoperative bleeding may be excessive, and postoperative liver failure is also prone to occur. In recent years, compared with traditional open surgery, laparoscopic surgery has many advantages, such as smaller surgical incision and faster postoperative recovery. In recent years, more and more centers have gradually transitioned to performing right hemihepatectomy through laparoscopy as much as possible. However, due to the difficulty of the surgery, steep learning curve, and postoperative complications, its adoption is limited to high-capacity surgical centers. Despite significant progress in laparoscopic liver resection technology, its clinical efficacy remains controversial, especially in laparoscopic right hemihepatectomy. More research is needed to confirm the feasibility and safety of this surgery. At present, it is unclear whether there is a difference in textbook outcomes (TO) between HCC patients undergoing open and laparoscopic right hemihepatectomy, and the association between TO and patient survival prognosis.

Diagnostic Value of Next-Generation Sequencing Analysis in Biliary Tract Tumours

The aim of this study is to identify a dysplasia- and CCA-specific NGS panel to increase the diagnostic sensitivity of histological and/or cytological examination of biliary tract stenosis.

A Multicenter Prospective Observational Study of Computer-aided Risk Perception and Prognosis Prediction in the Whole Process of Laparoscopic Hepatobiliary and Pancreatic Surgery

Artificial intelligence technology is used to realize high-quality 3D scene reconstruction, whole process segmentation, scene activity understanding for common surgery guidance in hepatobiliary surgery, as well as intelligent identification, perception, early warning of key events in the whole process of endoscopic surgery (such as bleeding, blocking, tumor location, anastomosis, etc.), and decision-making assistance

Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

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.

Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System

Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.

Ambulatory Surgery After Hepatectomy: Monitoring by Domomedicine Connected Tools and a Dedicated Nurse.

There are public health expectations for the development of outpatient surgery and increased comfort and quality of care for the patient. In this study, we are interested in evaluating the feasibility of an outpatient hepatectomy with a a close and secure follow-up at home: through a connected platform and a follow-up by a nurse. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management). This single-center study will includes prospectively 20 patients requiring liver resection of up to 2 segments. The primary endpoint is the rate of re-hospitalization due to a postoperative complication before Day 30 and the rate of conversion to conventional hospitalization (= early failure of outpatient management).

Preoperative Sildenafil Administration for Hepatectomy

Hepatectomy is an important treatment for liver diseases, and bleeding is one of the most common complications during dissection of the liver parenchyma. The 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 the 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 action inhibits phosphodiesterase-5 (PDE-5) and increases 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 liver resection related to CLCVP. This study aims to investigate the influence of preoperative oral administration of Sildenafil Citrate combined with IPM on IBL and surgical results during open or laparoscopic hepatectomy, as well as its safety and feasibility. It is expected to provide an innovative management optimization plan for reducing the bleeding in hepatectomy and to provide empirical support for the potential value of Sildenafil Citrate or Sildenafil-like drugs in improving the safety and quality of perioperative hepatectomy patients.

Application of Three- Dimensional Visualization Combined With ICG Molecular Fluorescence Imaging in Hepatolithiasis

This study adopted a retrospective study method to explore the clinical application value of 3D visualization combined with ICG molecular fluorescence imaging technology in hepatolithiasis, and further analyze whether 3D visualization combined with ICG molecular fluorescence imaging technology can improve the prognosis of hepatolithiasis by comparing with conventional surgery.

Randomized Study of Adjuvant Radiotherapy After Curative Resection of HCC With Narrow Margin (RAISE)

RAISE is a multicenter randomized controlled trial to assess the efficacy of adjuvant radiotherapy for controlling postsurgical recurrence in HCC patients with narrow margin (≤ 1 cm) after curative resection.

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

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.