Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

propranolol gel

Placebo

There is an unsatisfied medical need for a first-line treatment of localized uncomplicated proliferating Infantile Hemangioma with a good benefit/risk profile.

Pierre Fabre Dermatologie has developed a new formulation of propranolol (V0400 GL 01A) which is a topical gel adapted to paediatric use.

The objective of this study is to evaluate topical propranolol efficacy and safety in the management of localized hemangioma.

Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo

A Randomised, Double Blind, Controlled, Multicentre Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo.

Complete/nearly complete resolution of the Infantile Hemangioma at week 12 compared to baseline

categorical endpoints for Infantile Hemangioma evolution (4-points scale)

Persistence of complete/nearly complete resolution of the Infantile Hemangioma at week 24 compared to week 12.

Pierre Fabre Dermatology

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasm Metastasis

Respiratory Aspiration

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Central Nervous System Depressants

Platelet Aggregation Inhibitors

Analgesics

Anesthetics

Propofol

Sevoflurane

Remifentanil

Anesthetics, General

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, Inhalation

Analgesics, Opioid

Narcotics

The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.

The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.

Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.

Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.

Remifentanil will be used for analgesia in both groups.

Guizhi Du, MD, PhD

Jin Liu, MD, PhD

Yan Qiu, MD

The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.

With the increasing number of patients diagnosed with colorectal cancer, the proportion of patients undergoing surgical resection with general anesthesia increased. However, the operation can lead tumor cells releasing into the blood or peritoneal implantation, and the impaired immune response can make patients susceptible to the development of tumor metastasis and recurrence which is the the main reason of death. It is well known that B lymphocytes and T lymphocytes are the main immune cells, and B lymphocytes by secreting antibodies are related to humoral immunity and T lymphocytes which play the most important role in antitumor are related to cell-mediated immunity. Surgery stress leads to metabolic and neuroendocrine changes causing significant depression of immunity. Although general anesthesia could reduce surgical stress, studies indicated general anesthetics including intravenous and inhalational agents both have variable effects on tumor cells growth by immuno-modulation and some cytokines. A number of studies have demonstrated deleterious effects on the function of lymphocytes associated with the administration of volatile inhalational anesthetic agents. It was suggested that the use of volatile inhalational agent may augment tumor cells growth by inhibiting the activity of lymphocytes, NK cells and dendritic cells which are important for recognizing, capturing and killing tumor cells, however, the alternative propofol has a converse (beneficial) effect by decreasing the plasma level of cytokines secreted by activated lymphocytes, macrophages and NK cells. The detailed mechanism of how volatile anesthetics affect the activity of antitumor cells remains unknown. Thus the investigators will conduct the clinical investigation to study the effect of volatile anesthetics on the immune response and metastasis in patients undergoing colorectal cancer resection, exploring molecular mechanism involved if inhalational anesthetics show an effect. The findings of this study would be valuable for anesthetic regimen guidance of colorectal cancer patients undergoing surgical resection in terms of long-term survival.

Blood of the enrolled patients will be sampled at different time-points for examination of lymphocytes.

The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved

Comparison of the Effects of Total Intravenous Anesthesia and Inhalation Anesthesia on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and the Mechanism Involved: a Single-center, Randomized, Prospective Study

Patients receive a reoperation for any reason during hospitalization

The duration of patients stay in hospital

Blood will be drawn preoperatively ( at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CD4+/CD8+, B lymphocytes, dendritic cells, natural killer cells

Patients who remain alive without known colonal or rectal tumor recurrence

Patients who remain alive with known colonal or rectal tumor recurrence

Patients who remain alive with known colonal or rectal tumor metastasis

Patients who have a surgery under general anesthesia

Total intravenous anesthesia, inhalational anesthesia or combined anesthesia

Patients have radiotherapy for any cancer

Patients have chemotherapy for any cancer

Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing circulating tumor cells

Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing IL, TNF-α, IFN-γ and GCSF

Blood will be drawn preoperatively (at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CEA, CA199, GP87 and TPA.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	NCT01512173	Infantile Heman...	propranolol gel Placebo	35 Days - 150 Days	Pierre Fabre Dermatology
Study in Infants With Infantile Hemangioma to Compare Propranolol Gel to Placebo	NCT01512173	Infantile Heman...	propranolol gel Placebo	35 Days - 150 Days	Pierre Fabre Dermatology
The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved	NCT03193710	Colorectal Canc... Survival Rate General Anesthe... Lymphocyte Dest... Molecular Mecha...	Propofol Sevoflurane Remifentanil	18 Years - 65 Years	West China Hospital

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