ESGE Research

Criteria for Study Type I

• easy to perform
• open to a large number of centres throughout Europe
• with a simple and clearly defined objective
• adhering to common guidelines
• requiring no ethical committee approval in a large majority of countries

Criteria for Study Type II

• evaluating a new approach or new material
• classified phase II or randomized phase III
• open to a limited number of centres
• requiring ethical committee approval

Criteria for Study Type III (Registry)

• easy to perform
• open to a large number of centres throughout Europe
• with a simple and clearly defined objective
• requiring no ethical committee approval in a large majority of countries s

ESGE Study Type II - Eurobil 1

Acute biliary pancreatitis is a severe disease with 40% morbidity and 10% mortality. Severe pancreatitis with cholangitis clearly benefits from early endoscopic biliary sphincterotomy (EBS) in terms of morbidity and mortality. In other cases, the relevance of early EBS is not established. Since stone migration might lead to oedematous obstruction of the pancreatic duct and that the duration of obstruction seems to be associated with severity, the following trial was designed.

Randomized multicenter study comparing EBS within 48 hours of symptom onset versus standard treatment: EBS only if stones are present during delayed endoscopic cholangiography .

The ESGE Study Eurobil 1 Protocol

The ESGE Study Eurobil 1 CRF

ESGE Study Type III - EURODISSEC
European registry of ESD in the GI-tract

Endoscopic mucosal resection (EMR) is a proven endoscopic method in the treatment of premalignant and malignant lesions in the GI tract. In large, flat lesions en bloc resection with EMR can be difficult resulting in incomplete or piecemeal resection. Endoscopic submucosal dissection (ESD) is a promising endoscopic technique in the treatment of such lesions but also in the treatment of submucosal tumors. The aim of EURODISSEC is to assist endoscopist to evaluate the feasibility and the success of ESD in the endoscopic treatment of mucosal and submucosal lesions in the GI tract in EUROPE.

The ESGE Study EURODISSEC Protocol

The ESGE Study EURODISSEC CRF

MULTI-CENTER STUDY PROTOCOL:

“Contrast enhanced harmonic endoscopic ultrasound (CEH-EUS) used in the differentiation of focal pancreatic masses”

ClinicalTrials.gov ID: CEH-EUS-UMFCV-RO
Primary investigator and coordinator: Adrian Săftoiu, MD, PhD, MSc, Research Center of Gastroenterology and Hepatology, Gastroenterology Department, University f Medicine and Pharmacy Craiova, Romania

Aims of the study: The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and pancreatic cancer in a prospective multicenter design. The study will include patients with focal pancreatic masses evaluated by CEH-EUS and EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the patients being included based on a suspicion of focal pancreatic masses after transabdominal ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology and minimum 12 months follow-up.

Participation: The ESGE Research Committee would like to encourage EUS centres to participate in this very interesting multi-centre study. Please contact the study coordinator Dr. Adrian Săftoiu who will provide you with the study protocol and other relevant information (adrian.saftoiu@webmail.umfcv.ro or adriansaftoiu@aim.com).