Clinical methods applied to research studies
Module GASTROENTEROLOGIA APPLICATA AI TRIALS CLINICI

Academic Year 2022/2023 - Teacher: Gaetano BERTINO

Expected Learning Outcomes

Provide learners with the knowledge to understand the implementation, interpretation and application of clinical studies in diseases specific to Gastroenterology. Analyze the various types of clinical trials. The following topics will be studied in detail: Evidence-Based Medicine (EBM), levels of evidence, grade of recommendations, consensus conferences, guidelines, recommendations based on the studies available in Gastroenterology and diagnostic-therapeutic protocols in Gastroenterology. Clinical trials in the management of the most frequent gastrointestinal diseases (for example: gastroesophageal reflux disease, peptic disease, celiac disease, bowel syndrome, chronic hepatitis and viral, metabolic, autoimmune liver cirrhosis) will be illustrated and analyzed.

Course Structure

Conduct of the lesson in frontal mode with the help of slides in Power-Point format, illustration and commentary on the main clinical studies and the main guidelines.

If the teaching is given in a mixed or remote mode, the necessary changes with respect to what was previously stated may be introduced, in order to comply with the program envisaged and reported in the syllabus.

Required Prerequisites

Knowledge of anatomy, physiology, of the digestive system and in particular of the liver and pancreas.

Knowledge of elements of biostatistics.

Attendance of Lessons

Attendance to lessons is mandatory

Detailed Course Content

Clinical trials and guidelines for the following gastroenterological diseases:

• Gastroesophageal reflux disease and hiatal hernia; prevention and non-drug therapy of gastroesophageal reflux and esophagitis.

• Helicobacter pylori diseases.

• Peptic ulcer.

• Celiac disease 

• Irritable bowel syndrome.

• Chronic inflammatory bowel diseases: Crohn's disease, Ulcerative Rectum-Colitis and their complications

• Diverticular disease of the colon

• Clinical trials of chronic major hepatitis virus (HCV, HBV) infection.

• Steatosis (NAFLD), non alcoholic steatohepatitis (NASH).

• Alcohol liver disease.

• Autoimmune liver diseases: autoimmune hepatitis, primary biliary cholangitis, sclerosing cholangitis (outline).

• Wilson's disease (outline). Hereditary hemochromatosis and secondary hepatic siderosis (outline).

• Cirrhosis of the liver and its complications. Sarcopenia in the patient with liver cirrhosis.

• Acute and chronic pancreatitis.

Textbook Information

- Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-25.

- National and international guidelines published in journals recognized by the international scientific community.

Course Planning

 SubjectsText References
1Gastroesophageal reflux disease and hiatal hernia; prevention and non-drug therapy of gastroesophageal reflux and esophagitis.Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
2Helicobacter pylori infection.Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
3Peptic ulcerManuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
4Celiac diseaseManuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
5Irritable bowel syndrome.Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
6Crohn's disease, Ulcerative Rectum-ColitisManuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
7Diverticular disease of the colonManuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
8Clinical trials of chronic major hepatitis virus (HCV, HBV) infection.Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
9Steatosis (NAFLD), Non-alcoholic steatohepatitis (NASH).Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
10Autoimmune diseases of the liver: primary biliary cholangitis, sclerosing cholangitis (outline)Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
11Cirrhosis and its complications. Sarcopenia in the patient with liver cirrhosis.Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025
12Acute and chronic pancreatitis.Manuale di Gastroenterologia, UNIGASTRO, Editrice Gastroenterologica Italiana, edizione 2022-2025

Learning Assessment

Learning Assessment Procedures

Oral examination.

Examples of frequently asked questions and / or exercises

Clinical trials that have improved the diagnostic therapeutic assistance (PDTA) pathways in the following gastroenterological pathologies:

Gastroesophageal reflux disease

Helicobacter pylori pathologies.

Peptic ulcer.

Celiac disease.

Irritable bowel syndrome.

Crohn's disease, Ulcerative Rectum-Colitis and their complications.

Diverticular disease of the colon.

Clinical trials of chronic major hepatitis virus (HCV, HBV) infection.

Steatosis (NAFLD), Non-alcoholic steatohepatitis (NASH).

Autoimmune diseases of the liver: primary biliary cholangitis, sclerosing cholangitis (outline).

Wilson's disease (outline).

Cirrhosis of the liver and its complications. Sarcopenia in the patient with liver cirrhosis.

Acute and chronic pancreatitis.