IHU Strasbourg

Principal Investigator: Pr. Silvana PERRETTA

Main Objective: The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization. These data are usually collected during medical consultations and will enable the assessment of weight loss, quality of life and comorbidities improvement, reproducibility, and durability of the technique.

Study population: This study involves patients who will undergo an endoscopic gastric tubulization.

Expected study completion date: June 2026

Ethical committee approval: 19/03/2018

N° NCT: NCT03554902

Principal Investigator: Pr. Didier MUTTER

Main Objective: The main objective is to assess the medical and economic benefit of outpatient care for colorectal surgery in a university hospital center.

Study population: This study involves patients who will undergo colon surgery and who qualify for outpatient surgery regardless of their pathology.

Expected study completion date: April 2024

Ethical committee approval: 09/11/2018; MS1 02/05/2022

ANSM authorization: 07/06/2018; MS1 09/02/2022

N° NCT: NCT03760939

Principal Investigator: Pr. Silvana PERRETTA

Main Objective: The main objective is to assess the benefits of a revision during the follow-up of endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG.

Study population: This study involves all patients support for obesity in the Digestive and Endocrine Surgery Department of the Strasbourg’s NHC

Expected study completion date: September 2025

Ethical committee approval: 01/04/2021

N° NCT: NTC04945473

Principal Investigator: Dr. Michel VIX

Main Objective: The main objective is to compare weight loss for 2 years after surgery.

Study population: This study involves patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who wish to undergo obesity surgery.

Expected study completion date: September 2026

Ethical committee approval: 24/02/2020

N° NCT: NCT04282304

Principal Investigator: Pr. Julien POTTECHER

Main Objective: The aim of this study is to assess the relevance and reliability of an innovative clinical signs surveillance system, such as the MultiSense®-Strip Patch, during the monitoring of patients cared for in a post-ICU rehabilitation unit during both rest and exercise during the COVID-19 era.

Study population: This study involves all patients transferred from the ICU to the post-ICU in the Anesthesia Critical Care & Perioperative Medicine (Hautepierre Hospital, Strasbourg and Central Hospital, Nancy).

Expected study completion date: March 2024

Ethical committee approval: 27/11/2020

ANSM authorization: 06/11/2020

N° NCT: NCT04661423

Principal Investigator:  Pr Silvana PERRETTA

Main Objective: The aim of the study is to assess the impact of Infracyanine Green (ICG) and near infra-red (NIR) fluorescence imaging guidance in terms of number of lymph nodes resected and quality of gastrointestinal tract anastomoses in esophagogastric cancer surgery.

Study population: This study involves adult patients, male or female with resectable primitive esophageal or gastric cancer for whom a surgical resection is planned.

Expected study completion date: April 2024                      

Ethical committee approval: 18/01/2021

ANSM authorization: 18/12/2020

N° NCT: NCT04734821

Principal Investigator: Dr. Simona TRIPON

Main Objective: The main objective is to assess presence of MHE (minimal hepatic encephalopathy) in patients with cirrhosis and portal hypertension”

Study population: This study involves patients with cirrhosis and portal hypertension who underwent a CT scan or MRI in the last 3 months and are over 18 years old.

Expected study completion date: March 2024

Ethical committee approval: 16/12/2020

N° NCT: NCT04807803

Principal Investigator: Dr. Jérémy DANA

Main Objective: The main objective is to stratify the risk of hepatocarcinogenesis in patients with advanced chronic liver disease.

Study population: This clinical study will include adult patients with advanced chronic liver disease eligible to hepatocellular screening according to the European Association for the Study of the Liver (EASL) guidelines but with no history of treated hepatocellular carcinoma.

Expected study completion date: September 2024

Ethical committee approval: 04/05/2021

N° NCT: NCT04802954

Principal Investigator: Pr. Patrick PESSAUX

Main Objective: The main objective is to estimate the sensitivity and specificity of a simple classification “benign / malignant” of the nodes, established by the endoscopist using endoscopic ultrasound criteria, compared to the gold standard (anatomopathology).

Study population: This study involves adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection is planned.

Expected study completion date: June 2023

Ethical committee approval: 15/04/2021

N° NCT: NCT04899739

Principal Investigator: Dr. Léonardo SOSA-VALENCIA

Main Objective: The main objective is to evaluate the EUS navigation system’s procedure duration compared to standard procedure times.

Study population: This study involves adult patients, male or female, for whom a EUS procedure for pancreatic disease is programmed within the frame of their clinical care.

Expected study completion date: February 2024

ANSM authorization: 26/08/2022

Ethical committee approval: 25/07/2022

N° NCT : NCT05515705

Principal Investigator: Dr. Michel VIX

Main Objective:  The main objective is to create and assess a secure model of the hospital-city network to outpatient bariatric surgery.

Study population: This study involves patients for whom a bariatric ambulatory surgery is planned.

Expected study completion date: October 2023

Principal Investigator: Dr. Elise DELUCHE (CHU Limoges, AOMR)

Main Objective: The main objective is to evaluate the evolution of stress in young doctors during the announcement consultation between D0 (before the start of training) and M5 (at the end of 5 months of training).

Study population: This study involves medical interns, assistants and residents.

Expected study completion date: October 2024

HDH reference: F20221011092723

Principal Investigator: Dr. Barbara SEELIGER

Main Objective: The project aims to decrease the rate of unnecessary adrenal surgery by more accurate diagnostics and improved surgical planning using artificial intelligence image analysis.

Study population: This study involves patients treated for an adrenal lesion between January 2007 and December 2017. After validation of the technique, it may be extended to patients who underwent a surgery since 2000 at Kliniken Essen-Mitte (Germany) and Nouvel Hôpital Civil of Strasbourg (France).

Ethical committee approval: 13/11/2020

HDH reference: I40172106192019

Principal Investigator: Leonardo SOSA-VALENCIA

Main Objective: The main objective is to carry out a proof of concept of the use of an AI-based tool to detect in real time: – The pancreatic parenchyma and its ultrasound characteristics, – The part of the visualized pancreas (head, body, tail).

Study population: This study involves patients, male or female, undergoing or having undergone a pancreatic echo-endoscopy in the digestive surgery department of the NHC Strasbourg.

HDH reference: F20220309161612

Principal Investigator:Dr. Aïna VENKATASAMY

Main Objective: The objective of the study is to evaluate the interest of high-resolution ultrasound for the detection of lymph node micro- and macro-metastases, compared to high-resolution 7 T MRI, OCT and histology as gold standard.

Study population: This study involves patients, male or female, undergoing either an intervention including the removal of normal lymph nodes, not analyzed in clinical routine (examples: benign pathologies such as Sleeve, cholecystectomy, sigmoidectomy, etc.), or cancer surgery with resection lymph node (ENT, lung, digestive or gynecological cancers)

Expected study completion date: May 2024

HDH reference: F20211007150620

Ethical committee approval: 15/06/2022

Principal Investigator:Dr. Lise LECOINTRE

Main Objective: The objective of the study is to determine the diagnostic performance of an artificial intelligence model (deep learning (DL) or radiomics) in the evaluation of the depth of myometrial invasion (MI) and cervical stroma, as well as the histological grade on the MRI of endometrial cancer.

Study population: This study involves female patients with endometrial cancer whose initial workup contains an accessible pelvic MRI.

Expected study completion date: June 2024

HDH reference: F20220518093243

Principal Investigator:Dr. Patrick PESSAUX

Main Objective: The main objective is to improve the diagnosis and subsequent prediction of tumor response to treatments, using histological imaging and artificial intelligence (AI)-assisted personalized functional profiling to support the medicine of precision in the field of pancreatic duct adenocarcinoma (PDAC).

Study population: This study involves patients, male or female, undergoing a scheduled pancreatic surgery with pancreatic resection.

Expected study completion date: March 2023

HDH reference: F20220413120650