Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Wasting Syndrome

Cachexia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Gastrointestinal Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patients with cancer of digestive system requiring resection surgery will be included. They will have measure of height and weight, blood samples, skeletal muscle force, skeletal muscle index and muscle biopsy.

V1: Inclusion will be effectuated at the time of anaesthetic consultation V2: The day before and day of resection surgery about 1 month after V3: Follow-up at 1 month V4: Follow-up at 3 months V6: Follow-up at 6 months

Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)

Height and weight

Blood samples will be collected for measuring myostatin on blood at the time of anaesthetic consultation, the day before resection surgery, follow-ups at 1, 3 and 6 months. (V1, V2, V3, V4, V6)

Blood samples

Skeletal muscle force will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)

Skeletal muscle force

Skeletal muscle index will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)

Skeletal muscle index

Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)

Muscle biopsy

Karine ABBOUD, MD

Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.

Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia

Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)

Evaluate correlation between skeletal muscle force/index and degree myostatin. Skeletal muscle force/index will be determinated by skeletal muscle force/index results.

Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.

Evaluate Correlation between skeletal muscle force and index before resection surgery to estimate the extent of cachexia-induced muscle dysfunction by results tests.

Evaluate correlation between level of myostatin muscular expression and degree myostatin.

Level of myostatin muscular expression will be determinated by muscle biopsy. Degree myostatin will be determinated by blood samples with Enzyme Linked ImmunoSorbent Assay (ELISA) method.

Determinate correlation between level of myostatin muscular expression and skeletal muscle force and index after resection surgery.

Analysis level of myostatin muscular expression and blood samples results according to cancer stage, neoadjuvant treatment and chemotherapy.

Centre Hospitalier Universitaire de Saint Etienne

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Liver Neoplasms

Duodenal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Hematinics

Gastrointestinal Agents

Liver Extracts

Pancrelipase

Pancreatin

confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs

probe-based and needle-based confocal laser endomicroscopy

confocal laser endomicroscopy

Brice GAYET, MD

This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).

Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment.

The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

This study involves several innovations including :

* the robotization of the confocal miniprobe for a better an d more precise handling of the probe
* the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)
* the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images

Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)

Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE

during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication

each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc ...). Thanks to this, a more complete atlas of images obtained in digestive organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators, the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.

during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia	NCT03172403	Cancer of Diges...	Height and weig... Blood samples Skeletal muscle... Skeletal muscle... Muscle biopsy	40 Years - 80 Years	Centre Hospitalier Universitaire de Saint Etienne
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)	NCT02312167	Cancer of Diges... Ovarian Cancer	confocal laser ...	18 Years -	Institut Mutualiste Montsouris
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)	NCT02312167	Cancer of Diges... Ovarian Cancer	confocal laser ...	18 Years -	Institut Mutualiste Montsouris
Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia	NCT03172403	Cancer of Diges...	Height and weig... Blood samples Skeletal muscle... Skeletal muscle... Muscle biopsy	40 Years - 80 Years	Centre Hospitalier Universitaire de Saint Etienne
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)	NCT02312167	Cancer of Diges... Ovarian Cancer	confocal laser ...	18 Years -	Institut Mutualiste Montsouris

Spots Global Cancer Trial Database for cancer of digestive system