Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Hemorrhage

Colonic Neoplasms

Neoplastic Processes

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Natriuretic Agents

Vasoconstrictor Agents

Coagulants

All Drugs and Chemicals

Hematinics

Herbal and Botanical

Amino Acids

Vasopressins

Arginine Vasopressin

Liver Extracts

Hemostatics

Cola

Arginine

Patients will be treated with Empressin® 0.8 U/ml, 0.056 ml/kg/h during surgery.

Patients will receive normal saline 0.056 ml/kg/h during surgery.

Infusion of Argipressin 0.8 U/ml, 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the treatment arm.

Argipressin

Infusion of Normal Saline 0.056 ml/kg/h will be started as soon as the central line is placed, and continued until the end of surgery in the placebo arm.

Placebo

Ellinor Wisen, MD

kristina svennerholm, MD PhD

Kristina Svennerholm, MD PhD

Ellinor Wisén, MD

Kristina Svennerholm, MD, PhD

Andreas Kvarnström, MD, PhD

Lena Sand, MD, PhD

Magnus Rizell, MD, PhD

Infusion of Argipressin during hepatic resection surgery may reduce blood loss. It may also reduce transfusion requirements, and mitigate the perioperative inflammatory response compared to placebo. Subjects will be randomized to infusion of Argipressin or placebo during surgery. Blood loss, transfusion requirements, surgical data including length of stay in hsopital, inflammatory markers and markers of renal- intestinal- and cardiac injury will be assessed.

Hepatic resection is a major surgical intervention with high risk of substantial blood loss. The surgical means to reduce blood loss may impair perfusion and induce intestinal congestion. If blood flow to the liver can be influenced by pharmacological means, blood loss and transfusion requirements may be reduced. Moreover, the inflammatory system is involved in cancer development, and the anti-inflammatory properties of Argipressin may decrease the inflammatory response after hepatic surgery.

Argipressin is an endogenous substance, and part of the body's response to stress and trauma. Argipressin affects V1-receptors to produce vasoconstriction. It is also involved in inflammatory reactions and affects platelets.

Patients will be stratified according to planned type of surgery (open/laparoscopic) and planned extent of resection, and randomized to etiher infusion of Argipressin or placebo (normal saline) during surgery. In all other aspects, the participants will be treated according to the institution protocol for hepatic resection. The study drug will be started as soon as the central line is placed, and discontinued at the end of surgery. Hemodynamic data will be collected during surgery, and blood and urine-samples will be obtained during and after surgery for analysis of inflammatory markers and markers of organ injury.

Singel center double-blinded, randomized, placebo-controlled trial.

Randomisation will be handled by a nurse not involved in the study, and both the patient, treating physician and nurse, the study nurse and the investigators will be blinded to the study treatment.

Argipressin's Influence on Blood Loss During Hepatic Resection

Influence of Argipressin on Blood Loss During Hepatic Resection; a Double-blinded, Randomized Placebo-controlled Trial (ARG-01)

Metadata will be shared by the Swedish National Data Service (SND, https://snd.gu.se/en) and selected psedonymised data will be made available on reasonable request, after proper confidentiality and ethics assessment. As the study is still ongoing, the extent of data made available will be decided after study closure, and also the time span for availability.

Blood loss at the end of surgery, measured according to the investigator's instructions, by visual assessment of suction devises and gauze, and subtraction of ascites and irrigation fluids.

Blood transfusion (ml) at the end of surgery and at postoperative day 1 and 2 and 5 respectively.

Levels of White Blood Cell count, C Reactive Protein, Platelet count and Albumin at the end of surgery and postoperative day 1-5

Levels of Interleukin (IL)-1 Beta, IL-6, IL-8, IL-10, Monocyte chemoattractant protein-1, Stromal Cell-Derived Factor-1 alpha, Intercellular Adhesion Molecule, Complement (C) 3a, C5b-9 at the end of surgery and postoperative day 1 and 2.

duration of Pringles manouvre (min), duration of resection phase (min) and surgery (min)

achievement of CVP (central venous pressure) goal (mmHg), as recorded on the Phillips monitor.

Total use of noradrenaline (micrograms/minutes of surgery/ bodyweight)

Postoperative complications including death and radicality of resection at 30-day follow up.

Change in plasma creatinine (micro-mole/L)

Change in urine creatinine and urine \[TIMP-2\] x \[IGFBP-7\] (quota, no unit)

Kristina Svennerholm

Principal investigator, MD, PhD

Skin and Connective Tissue Diseases

Breast Neoplasms

Liver Neoplasms

Breast Diseases

Skin Diseases

Liver Diseases

Mario Serradilla Martín, MD FACS

Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in females worldwide. Approximately, 20-30% of breast cancer cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastasis. The proper indication for surgical treatment of breast cancer liver metastasis is still a matter of discussion. Surgery is becoming more practical and effective than conservative treatment in improving the outcomes of patients with breast cancer liver metastasis and liver metastasis surgery is included in an onco- surgical strategy.

Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in female's worldwide . Approximately, 20-30% of breast cancer (BC) cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastases (BCLM) . The presence of liver metastasis has markedly worsened the prognosis of patients, and the median survival was reported to be 3.8-29 months.

Metastatic breast cancer is considered to be a disseminated disease and many oncologists remain reluctant to include surgery within the multimodal treatment strategy of these patients . Although systemic treatments can achieve approximately 60% of responses in breast cancer recurrence, long-term survival is exceptional only with medical treatment . Without liver resection, the average survival reported after the first onset of liver metastases is distributed over a range from 1 to 15 months. Surgery is becoming more functional and effective than conservative treatment in improving the poor outcomes of patients with BCLM . However, there is no generally acknowledged set of standards for identifying candidates who will benefit from surgery. The proper indication for surgical treatment is still a matter of discussion; surgical resection should be assessed when the following premises are met: low surgical risk, low metastasis number, complete macroscopic liver removal, absence of proven extrahepatic disease by positron emission tomography and computed tomography, objective response to chemotherapy before surgery, and long disease-free interval. Breast cancer liver metastasis surgery (BCLMS) is included in an onco-surgical strategy.

Most of the published series of patients with liver metastases of breast cancer who have undergone surgery come from a single center or few centers and there are hardly any long-term results, so we consider necessary to carry out a multicenter review of patients who underwent surgery in high volume centers across Europe belonging to the European-African Hepato-Pancreato-Biliary Association (E-AHPBA) to asses survival and disease-free survival and to determine which patients may benefit from surgery.

This retrospective multicenter cohort study in centers performing BCLMS aims to provide an assessment of the outcomes across E-AHPBA centers.

Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study

LIBREAST STUDY: Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study

Disease-free time and survival at 1st year.

Disease-free time and survival at 3th year.

Disease-free time and survival at 5th year.

Yes/No of Luminal A/Luminal B/ HER2+/Triple negative-basal like

Yes/No of Chemotherapy, Hormonetherapy, AntiHER2Therapy, Antiangiogenics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Argipressin's Influence on Blood Loss During Hepatic Resection	NCT05293041	Colon Cancer Li... Inflammatory Re... Vasopressin Cau...	Argipressin Placebo	18 Years -	Sahlgrenska University Hospital, Sweden
Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study	NCT04817813	Breast Cancer Liver Metastase... Surgery		18 Years - 100 Years	Hospital Miguel Servet
Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study	NCT04817813	Breast Cancer Liver Metastase... Surgery		18 Years - 100 Years	Hospital Miguel Servet

Spots Global Cancer Trial Database for hepatic surgery