Neoplasms

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Papillary Thyroid Carcinoma

Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy

Ultrasonic coagulation device (Harmonic ACE® scalpel)

bipolar energy sealing system (LigaSure Precise)

Ja Seong Bae, MD,phD

The aim of the study is to evaluate differences between use of Ultrasonic Coagulation Device (New Harmonic ACE™, Ethicon endo-surgery) and Bipolar Energy Sealing System (LigaSure Precise™, Covidien) in surgery for thyroid cancer.

Abbreviations: Ultrasonic Coagulation Device (UC), Bipolar Energy Sealing System (BES), Recurrence-free survival (RFS), Overall survival (OS)

Background: Thyroid is an organ that has abundant vessels. In thyroid surgery, it should be cautious to avoid injury of the recurrent laryngeal nerve and parathyroid, thus careful hemostasis during surgery is crucial for surgeons who perform thyroid surgery. Recently, there have been significant advances in vessel sealing systems for the occlusion of vessels during surgery as endoscopic surgery has been developed. UC and BES are now commonly used in thyroid surgery. However, only a few studies have compared the two surgical devices to determine which technique is superior in terms of operative time and complication rate. Thus, this single-blind prospective randomized trial is conducted to determine if there was a difference in operative time, complication rate, postoperative drainage volume, admission time, cost, and, furthermore, oncologic outcomes (RFS and OS) between the two surgical devices in surgery for thyroid cancer.

Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System

Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated With the Harmonic ACE® Scalpel and LigaSure Precise™ Instrument During Conventional Thyroidectomy: A Single-blind Prospective Randomized Controlled Trial

Seoul St. Mary's Hospital

Division of Breast and Endocrine Surgery, Department of Surgery, The Catholic University of Korea College of Medicine

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Chlorotrianisene

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Patients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort.

Patients who received 1 TACE about a month after the operation were included in the control cohort.

For patients with PVTT, they received adjuvant therapy of PD1 (200mg intravenously every 3 weeks for a total of 18cycles) plus Lenvatinib (8mg orally once a day for 1 year) 2-4 weeks after surgery; for patients with other high-risk factors for recurrence, they PD-1(200mg intravenously every 3 weeks for a total of 9cycles) monotherapy 2-4 weeks after surgery.

PD-1 inhibitors

Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.

TACE

xiaoping Dr Chen

For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.

We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.

Cancer tissues were collected after surgery. The genetic differences between the responding and non-responding lesions to PD-1-based adjuvant therapy were compared using transcriptomic and proteomic analyses.

Postoperative Adjuvant Therapy of HCC Based on PD-1

PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection

The primary outcomes of this study include disease-free survival

The secondary outcomes of this study include overall survival

The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

Chen Xiaoping

Professor

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Heart and Blood Diseases

Breast Neoplasms

Insulin Resistance

Hyperemia

Breast Diseases

Skin Diseases

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

Estrogens

Breast cancer patients receive 2 x preoperative carbohydrate loading \[PreOP(TM)\] before surgery; the 1st dose 18 hours before and 2nd dose 2-4 hours before surgery.

Breast cancer patients receive standard prep fasting procedure with nil food per os 8-10 hours before surgery, drinking tap water until 2 hours before surgery.

Mixture of Carbohydrates; standard amount designed for enhanced recovery after surgery (ERAS) i.e. preoperative carbohydrate loading before long standing surgery to enhance recovery.

PreOP

Svein Skeie, PhD

The investigators have already proven that Mitotic Activity Index (MAI)is the most robust measure of proliferation in breast cancer tissue.

The purpose was to study whether 18 and 2-4 hours pre-operative per-oral carbohydrate loading (often given in gastrointestinal surgery i.e. enhanced recovery after surgery=ERAS) influences proliferation in the tumor, serum insulin characteristics, metabolic profile and survival.

It has been postulated that a "Western-style" diet, rich in carbohydrates (especially high glycemic carbohydrates) may have an effect on the incidence of breast cancer, and perhaps also prognosis. This may be mediated through the insulin-related pathways in breast cells which may show insulin-dependent proliferation, which may alter outcome.

Aims:

To study:

1. The inter-patient variation in insulin and insulin-related characteristics in the blood taken just before the operation from breast cancer patients, on a usual pre-operative fasting schedule;
2. The influence of the variation in insulin and insulin-related characteristics on proliferation and other cell biological features in the breast cancers of these patients;
3. Whether 4 and 18-hours pre-operative hyperglycaemic glucose loading (to reduce postoperative insulin resistance) influences proliferation (Mitotic Activity Index (MAI) and other cell biological features in breast cancer\*
4. The influence of the short-term effect of a pre-operative low-glycaemic carbohydrate isocaloric diet on proliferation and other cell biological features of the primary breast cancer cells (Low-glycemic isocaloric diet intervention study);
5. Epidemiological risk factors: The correlation between epidemiological risk factors, insulin and insulin-related characteristics, proliferation, cell biological features and other biomarkers in breast cancer patients.
6. Estrogen Receptor positive tumors will be analyses separately.
7. Relapse free survival
8. Breast Cancer Specific Survival.

The Short-term effect of carbohydrates will be assessed in a randomized intervention study, where 30 patients receive oral carbohydrates 18 and 4 hours before surgery and 30 patients receive fasting procedure/water.

Primary Outcome

1. Proliferation in the tumor as measured by MAI.

Secondary Outcomes:

1. Serum insulin characteristics (S-insulin, S- insulin c-peptide, S-IGF and S-IGFBP3) will be measured at various peri-surgical timepoints
2. Changes in metabolic profile\* in the tumor and in serum samples
3. Patient Reported Outcome Measures (PROM) on well being
4. Relapse free survival
5. Breast Cancer Specific Survival

   * Metabolic profile assessed by High Resolution Magnetic Resonance Spectroscopy (HR-MRS) in the tumor and in serum samples.

Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment

Breast cancer is 100 x more frequent in women than in men.

Breast Cancer Diet Intervention Study

The Effects of Insulin and Insulin-related Characteristics, and Short-Term Low-glycemic and High-glycemic Carbohydrate Intervention on Breast Cancer Biomarkers and Survival

All data will be available to all researches involved in the study included the statistician allocated to the study.

Secretion of insulin into serum; unit, mIE/L (milli international units pr liter)

Patient Reported Outcome Measures (Questionaire)

Metabolic profiling in the primary tumor and in the serum samples; measure content of lactate, glycine, choline, fatty acids and lipoproteins

Time from surgery to a relapse (Loco-regional, contralateral and systemic) is experienced

Time from surgery to dead of disease or all other causes of death.

Measure of total insulin secreted; unit, nM (nano molar)

Measure of Insulin growth factor type 1; unit, nM (nano molar)

Measure of Insulin growth factor binding protein 3; unit mg/L (milligram per liter)

Expression of Progesteron Receptor in the primary tumor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System	NCT01565486	Thyroid Cancer	Ultrasonic coag... bipolar energy ...	20 Years - 80 Years	Seoul St. Mary's Hospital
Postoperative Adjuvant Therapy of HCC Based on PD-1	NCT05307926	Hepatocellular ... RFS	PD-1 inhibitors TACE	18 Years - 75 Years	Tongji Hospital
Breast Cancer Diet Intervention Study	NCT03886389	Early-stage Bre... Carbohydrate En... Proliferation Insulin Resista... Estrogen Recept...	PreOP	25 Years - 100 Years	Helse Stavanger HF
Breast Cancer Diet Intervention Study	NCT03886389	Early-stage Bre... Carbohydrate En... Proliferation Insulin Resista... Estrogen Recept...	PreOP	25 Years - 100 Years	Helse Stavanger HF
Safety and Efficacy Study of Ultrasonic Coagulation Device and Bipolar Energy Sealing System	NCT01565486	Thyroid Cancer	Ultrasonic coag... bipolar energy ...	20 Years - 80 Years	Seoul St. Mary's Hospital

Spots Global Cancer Trial Database for rfs

Every month we try and update this database with for rfs 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 rfs

Every month we try and update this database with for rfs 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 rfs 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.