Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Hemorrhage

Liver Neoplasms

Hematinics

All Drugs and Chemicals

Coagulants

Liver Extracts

Hemostatics

Use of hemopatch like a control of bile leakage/sealant during liver resection surgery.

Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery.

Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement

Hemopatch

Standard of care include other sealant / hemostatic devices as patches or liquid/gels

Standard of care

Clara Rosso Fernández, PhD

Lydia Barrera, PhD

Miguel Angel Gómez Bravo, PhD

This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.

Liver resection is the only potentially curative treatment in malignant or benign hepatobiliary lesions. Biliary leakage is a postoperative complication (5-10%) which may have considerable consequences. Surgical techniques and devices to facilitate the control of bile leakage have been developed in the last decades and have minimized operative risks of liver resection. Nevertheless, hepatic parenchymal transection can be associated with bile leakage due to the division of small ducts. In order to achieve control over parenchyma from the section surface and to prevent intraperitoneal complications attributed to bile leakage/bleeding various locally applicable agents are in use. This control of bile leakage include fibrin sealant and synthetic glues. Evidence from randomized controlled trials regarding the use of fibrin sealants on their own or combined with a collagenfleece has shown Little efficacy.

A new collagen and polyethylene glycol hemostatic/sealant patch (Hemopatch) \[Baxter, Vienna, Austria\] is indicated for local hemostasis of capillary bleeding and bleeding of parenchymal organs. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus providing an additional impetus as a sealant agent.

The investigators aim to demonstrate the sealing capability of hemopatch and to prove its non-inferiority to the standard of care (may include other sealant / hemostatic devices as patches or liquid/gels). There will be 2 groups to compare. The study group where Hemopatch is applied at the end of surgery. And the control group, where standard of care measures will be applied at the end of surgery. The end-point is the assessment of control of bile leakage at 1, 2, 3, and 4 day, during the hospital stay and or at 30 days for both treatment group. The secondary end-points are bleeding complications (re-bleeding, hematoma formation), volume of fluid drained on day 1 to day 4 after surgery, hemoglobin variation from pre-operative until discharge and post-operatory complications until 30th day pos-op.

Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study

Standard of Care Versus Hemopatch® During Liver Resection

Standard of Care Versus a New Collagen and Polyethylene Glycol Haemostatic/Sealant Patch (Hemopatch) During Liver Resection. A Multicentre, Non-inferiority Prospective Randomized Study (IBERLIVER-study)

Anonymized data for IPD is planned to be shared with all participants within 6 months of data completion

Classification A,B,C. According to International Study Group of Liver Surgery (ISGLS)

* Postoperative Ileus (refers to obstipation and intolerance of oral intake due to non mechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal or non abdominal surgery)
* Allergic reaction (Signs and symptoms are urticarial rash; pruritus; flushing; angioedema of the face, extremities, or laryngeal tissues (leading to throat tightness with stridor, or rarely asphyxiation); wheezing; gastrointestinal symptoms; and/or hypotension after use Hemopatch)
* Intrabdominal Infection (It describes a diverse set of diseases. It is broadly defined as peritoneal inflammation in response to microorganisms, resulting in purulence in the peritoneal cavity.)

Death: number of patients dying during study

analysis of bilirubin (mg/dL),in the drain fluid

Total volume of blood, quantified though aspiration and drainage (Quantification of total number of deciliters (dL) of blood gathered)

Quantification of hemoglobin (mg/dL), in the drain fluid

Presence (YES or NO compatible imagen of hemorrhage )of post-hepatectomy hemorrhage or Hematoma formation (Valid imaging tests of presence or absence can be checked by : abdomen ecography, TAC or RNM)

Quantification of number of packed red blood cells

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Recurrence

Esophageal Neoplasms

Cholangiocarcinoma

Pancreatic Neoplasms

Stomach Neoplasms

Calculi

Gastrointestinal Diseases

Cholangitis

Pancreatitis

Pancreatitis, Chronic

Constriction, Pathologic

Jaundice

Duodenal Neoplasms

Gallstones

Cholelithiasis

Cholecystolithiasis

Pancreatic Diseases

Barrett Esophagus

Esophageal Diseases

Bile Duct Diseases

Choledocholithiasis

Pancreatic Pseudocyst

Jaundice, Obstructive

Pancreas Divisum

Bile Duct Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Pathological Conditions, Anatomical

Biliary Tract Diseases

Chronic Disease

Disease Attributes

Hyperbilirubinemia

Skin Manifestations

Biliary Tract Neoplasms

Gallbladder Diseases

Common Bile Duct Diseases

Cysts

Pancreatic Cyst

Duodenal Diseases

Congenital Abnormalities

Digestive System Abnormalities

Esophageal Cancer

Pancreatic Cancer

Bile Duct Cancer

Chronic Graft Versus Host Disease

Stomach Cancer

Acute Graft Versus Host Disease

Any group that went Interventional Endoscopy procedures.

Advanced imaging endoscopic or therapeutic endoscopy

Interventional Endoscopy

Michel Kahaleh, MD

Monica R Gaidhane, MD, MPH

Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.

Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Endoscopic Retrograde Cholangiopancreatography, Endoscopic Ultrasound and Interventional Endoscopy in Pancreatico-biliary, Gastrointestinal and Esophageal Disorders

Collection of procedure specific details of all Interventional Endoscopies

Weill Medical College of Cornell University

Chief, Advanced Endoscopy

Neoplasm Metastasis

Liver Failure

Hepatic Insufficiency

Liver Diseases

Micronutrients

Iron

Participants will be recruited after they have been diagnosed and their treatment has been planned by a multidisciplinary tumor board. Patients indicated to undergo major liver resection (\> 3 segments based on Brisbane classification \[23\]) will be eligible for participation.

MRI scans will be performed at the Champalimaud Foundation using a 1.5T scanner after patients have fasted for 4 hours. Transverse abdominal T1 maps will be acquired to estimate extracellular fluid (which increases in cases of fibrosis and inflammation) and T2\* maps will be acquired to estimate liver iron levels. These quantitative MRI maps will be laid onto the volumetric images of Couinaud segments. Multi-slice quantitative maps will be generated using Liver MultiScan software (Perspectum, UK) with operators blinded to patient status. T1 measurements will be adjusted for the iron level to give iron-corrected T1 maps (cT1). Reference ranges for cT1 have been defined in the general population. PDFF maps of the liver will be calculated using MRI multi-echo and spoiled-gradient-echo acquisition. No intravenous contrast agents will be used in Liver MultiScan maps and the total scan duration will be approximately 30 minutes.

Multiparametric MRI scan of the liver

Arianeb Mehrabi, Professor

The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection.

The main questions to be answered are:

* Can multiparametric MRI predict the postoperative liver function?
* Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.

In patients being considered for major liver resection, volumetric and functional evaluation of the future liver remnant should ideally be combined to reduce the risk of posthepatectomy liver failure (PHLF) and other adverse outcomes. Quantitative multiparametric magnetic resonance imaging (MRI) can measure liver health by assessing parenchyma fibrosis and inflammation. This has shown promising results in predicting postoperative liver performance. The current study aims to assess the benefit of this MRI-based technology in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy.

Prospective observational clinical study in a single hepatobiliary surgery center. With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. Postoperative liver function and complications will be reported for 90 days after surgery. Preoperative MRI assessment scores and postoperative outcomes will be correlated to determine whether multiparametric MRI scans can accurately predict the risk of postoperative liver-specific complications (primary endpoint) as well as postoperative liver function, surgery-specific complications, the overall complication rate, quality of hospital care, and length of stay. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power. This study will include 33 patients and results are expected in 2024. If successful, this investigation will support the use of quantitative multiparametric MRI to guide surgical decision-making. This will represent a non-invasive, diagnostic, volumetric, and segmental functional test for the preoperative workup of patients being considered for major hepatectomy.

Quantitative MRI and Outcomes of Liver Resection

Predicting the Outcomes of LIVEr Resection Using Quantitative Magnetic Resonance Imaging: the POLIVER Study

Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy liver failure after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy biliary leakage after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and posthepatectomy hemorrhage after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and major complications according to Clavien-Dindo classification (\>IIIA) after major liver resection

Correlation between future liver remnant performance (combined measure of liver volume, PDFF, and cT1) and mortality according to Clavien-Dindo classification (\>IIIA) after major liver resection

Fundacao Champalimaud

University Hospital Heidelberg

Professor Dr. med.

Gregor A. Stavrou, MD

Gregor A. Stavrou, Dr. Dr. habil

Omid Ghamar Nejad, MD

Achievement of tumor-free resection margin with the largest possible remnant liver parenchyma is the major challenge in hepatic surgery. Therefore, perioperative tumor detection, anatomical mapping of liver segments and also nearby structures are vital to improve the short- and long-term surgical outcomes. Over last decades, several real-time methods have been introduced for this purpose. These methods are mostly based on the utilizing of traceable dyes, which are excreted into the biliary tract. With the advances in minimal invasive surgery and video technology, indocyanine green became the most used dye in this manner. It has been demonstrated that using indocyanine green, small liver tumors can be detected, which cannot be identified using conventional intraoperative methods. Based on the literature, the reported sensitivity of tumor detection using indocyanine green is ranging between 98%-100%, while conventional methods could not reach 90% sensitivity. Posthepatectomy bile leakage, as well as in- or outflow distributions due to the potential vascular reconstructions, are some of the most common complications that can occur especially after complex liver surgeries. Beside the abovementioned advantages of indocyanine green, several researchers have also shown the feasibility of indocyanine green to identify the intraoperative bile leaks and any in- or outflow distributions. Nevertheless, laparoscopic assisted liver surgery is technically challenging, mostly because of the restricted degrees of instrument movements, camera instability, and loss of depth perception. In particular, the loss of depth perception and inaccurate object localization can lead to intraoperative complications and a long learning curve. Advances in video technology, namely 4K ultra-high-definition imaging have been developed to reduce perioperative complications and to shorten the learning curve during laparoscopic liver surgery. This is the first prospective study evaluating the impact of indocyanine green imaging during 4K laparoscopic liver surgery on real-time tumor detection and surgical outcomes.

Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection

Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection: A Single-centre Prospective Study

Using indocyanine green and fluorescence camera

Based on the Clavien-Dindo classification

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Standard of Care Versus Hemopatch® During Liver Resection	NCT03166683	Liver Cancer Hemorrhage Live... Bile Leak Surgery Tumor Liver	Hemopatch Standard of car...	18 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders	NCT01438385	Ampullary Cance... Duodenal Cancer Bile Duct Cance... Bile Duct Disor... Gallstones Obstructive Jau... Pancreatic Diso... Colorectal Canc... Esophageal Canc... Barrett's Esoph... Gastric Maligna... Pancreatic Canc... Pediatric Gastr... Cholangiocarcin... Pancreatic Pseu... Acute and Chron... Recurrent Pancr... Cholangitis Bile Leak Biliary Strictu... Pancreatic Divi... Biliary and Pan... Choledocholithi...	Interventional ...	18 Years -	Weill Medical College of Cornell University
Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders	NCT01438385	Ampullary Cance... Duodenal Cancer Bile Duct Cance... Bile Duct Disor... Gallstones Obstructive Jau... Pancreatic Diso... Colorectal Canc... Esophageal Canc... Barrett's Esoph... Gastric Maligna... Pancreatic Canc... Pediatric Gastr... Cholangiocarcin... Pancreatic Pseu... Acute and Chron... Recurrent Pancr... Cholangitis Bile Leak Biliary Strictu... Pancreatic Divi... Biliary and Pan... Choledocholithi...	Interventional ...	18 Years -	Weill Medical College of Cornell University
Quantitative MRI and Outcomes of Liver Resection	NCT06181318	Liver Cancer Liver Failure Bile Leak Liver Metastase...	Multiparametric...	18 Years -	University Hospital Heidelberg
Feasibility and Impact of ICG and 4K Overlay in Laparoscopic Hepatic Surgery on Real-time Tumor Detection	NCT04946591	Laparoscopic He...		18 Years -	Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

Spots Global Cancer Trial Database for bile leak

Every month we try and update this database with for bile leak cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bile leak

Every month we try and update this database with for bile leak cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bile leak cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.