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Ongoing clinical studies at the IHU

ENDOSLEEVE - TREATMENT OF MORBID OBESITY BY ENDOSCOPIC GASTRIC TUBULIZATION

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

COLON AMBU - CLINICAL AND ECONOMIC EVALUATION OF COLORECTAL SURGERY IN OUTPATIENT CARE

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 2027

Ethical committee approval: 09/11/2018

ANSM authorization: 07/06/2018

N° NCT: NCT03760939

ESG IRM - ASSESSMENT OF THE IMPACT OF ENDOSCOPIC GASTRIC REVISION BY APPLICATION OF ADDITIONAL SUTURES ON WEIGHT LOSS AFTER ENDOSCOPIC SLEEVE GASTROPLASTY IN OBESE PATIENTS

Principal Investigator: Prof. 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 2026

Ethical committee approval: 01/04/2021

N° NCT: NTC04945473

PICO - RANDOMISED TRIAL OF COMPREHENSIVE, INTENSIVE, ON-SITE BEHAVIOURAL LIFESTYLE INTERVENTION VERSUS USUAL CARE DURING THE PREOPERATIVE PREPARATION FOR BARIATRIC SURGERY

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 2028

thical committee approval: 24/02/2020

N° NCT: NCT04282304

MONIREA - USE OF RDS MULTISENSE® IN POST-ICU PATIENTS IN THE COVID-19 ERA

Principal Investigator: Prof. 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

FOREGUT - PROSPECTIVE STUDY OF THE CONTRIBUTION OF FLUORESCENCE IN THE GUIDANCE OF LYMPHADENECTOMY AND IN PEROPERATIVE EVALUATION OF PRE-ANASTOMOTIC TISSUE PERFUSION IN LAPAROSCOPIC OESOGASTRIC ONCOLOGIC RESECTIONS

Principal Investigator: Prof. 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 2026

Ethical committee approval: 18/01/2021

ANSM authorization: 18/12/2020

N° NCT: NCT04734821

EVENCIPOR - EVALUATION OF MINIMAL HEPATIC ENCEPHALOPATHY IN PATIENTS WITH CIRRHOSIS AND PORTAL HYPERTENSION

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 2026

Ethical committee approval: 16/12/2020

N° NCT: NCT04807803

STARHE - RISK STRATIFICATION OF HEPATOCARCINOGENESIS USING A DEEP LEARNING BASED CLINICAL, BIOLOGICAL AND ULTRASOUND MODEL IN HIGH-RISK PATIENTS

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 2025

Ethical committee approval: 04/05/2021

N° NCT: NCT04802954

ECHOSURG - NON-RANDOMIZED PROSPECTIVE STUDY FOR INTRAOPERATIVE ENDOSCOPIC ULTRASOUND WITH FINE NEEDLE BIOPSY FOR THE DIAGNOSIS OF METASTATIC LESIONS OF OPERATIVE PANCREATIC CANCER

Principal Investigator: Prof. 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: December 2025

Ethical committee approval: 15/04/2021

N° NCT: NCT04899739

APEUS-NAV1 - FIRST-IN-HUMAN NAVIGATION EUS SYSTEM CLINICAL STUDY

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 2025

ANSM authorization: 26/08/2022

Ethical committee approval: 25/07/2022

N° NCT : NCT05515705

MDS1 OSSICLEAR - « FEASIBILITY STUDY ON SOUNDUCT NON-INVASIVE BONE AND CARTILAGE CONDUCTION HEARING AIDS »

Principal Investigator: Pr. Christian DEBRY

Main Objective: The primary objective of this investigation is to demonstrate objective tonal and vocal hearing improvement by audiometry with the MDS1 Ossiclear solution fitting versus bare ears, in silence and in noise, with adjustment.

Study population: Patients of both sexes, presenting all type of deafness without any particular restriction.

Expected study completion date: June 2024

ANSM authorization: 15/11/2023

Ethical committee approval: 25/01/2024

BARAMBU - EVALUATION OF THE HOSPITAL-CITY NETWORK TO OUTPATIENT BARIATRIC SURGERY

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: April 2026

ACACIAS 2 - LEARNING CANCER ANNOUNCEMENT CONSULTATION BY SIMULATION

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

APEUS-AI1 - AUGMENTED PANCREATIC ENDOSCOPIC ULTRASOUND ASSISTED BY ARTIFICIAL INTELLIGENCE

Principal Investigator: Dr. Léonardo 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

LYNOP - LYMPH NODE PROTOCOL - VERY HIGH-RESOLUTIN IMAGING OF NORMAL AND METASTATIC LYMPH NODES

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: October 2024

HDH reference: F20211007150620

Ethical committee approval: 15/06/2022

ENDOMETRE IA - AUTOMATED STAGING OF ENDOMETRIAL CANCER USING AN MRI BASED DEEP LEARNING MODEL

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

CANCER PROFILE - PREDICTIVE AND PERSONALIZED MEDICINE OF PANCREATIC CANCER

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.

HDH reference: F20220413120650

5G-OR1 - « VIRTUALISATION AND MEASUREMENT OF DATA FROM OPERATING ROOM EQUIPMENT DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE »

Principal Investigator: Dr. Alain GARCIA

Main Objective: The main objective is to determine the data flow, in terms of types and volume of data, generated during a minimally invasive operation.

Study population: Adult patients, male or female, undergoing programmed minimally invasive surgery known as “simple” (laparoscopic cholecystectomy, laparoscopic inguinal hernioplasty) or “complex” (bariatric surgery: sleeve gastrectomy and gastric bypass, colorectal surgery: left colectomy or procto sigmoidectomy).

HDH reference: F20220718110450

MONIT-OR1 - « MULTIMODAL CAPTURE OF DIGITAL DATA IN THE OPERATING ROOM DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE»

Principal Investigator: Dr. Alain GARCIA

Main Objective: The aim of this study is to advance the development of intelligent systems capable of providing surgical assistance (based on the holistic exploitation of digital data available in the operating room) but also capable of producing surgical reports augmented with surgical video sequences automatically extracted from the recordings made.

Study population: Adult patients, male or female, undergoing robot-assisted laparoscopic surgery for one of the following procedures: Benign pathologies (cholecystectomy; abdominal wall hernia repair: Inguinal hernioplasty, Abdominal wall hernioplasty; Appendicectomies (excluding instability)); Total, left and right colectomies (and variants); Oncological gastrectomies; Total or partial gastrectomy; Anti-reflux/bariatric surgery (gastric fundoplicature, bariatric surgery (sleeve gastrectomy and gastric bypass)); Hepatectomies (hepatic segmentectomy, hepatic biopsy); Pancreatectomies (distal pancreatectomy, laparoscopic duodenopancreatectomy); Laparoscopic splenectomy.

HDH reference: F20220715162605