Neoplasms

All Conditions

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All subjects will undergo the intraoperative pancreatoscopy with SpyGlass procedure.

Visualization of main pancreatic duct with SpyGlass catheter.

SpyGlass

Marco Del Chiaro, MD

G.V. Rao, MD

Richard Burkhart, MD

Marc Besselink, MD

Yi Miao, MD

Sohei Satoi, MD

Urban Arnelo, MD

Christian Schmidt, MD

To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.

The primary objective of this study is to demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas. A secondary study objective is to generate a hypothesis for a subsequent randomized controlled trial comparing diagnostic accuracy of intra-operative pancreatoscopy and SpyBite™ with the diagnostic accuracy of intra-operative frozen section in patients undergoing resection

Intra-operative Pancreatoscopy in Patients With IPMN

Intra-operative Pancreatoscopy in Patients With Intraductal Papillary Mucinous Neoplasm (IPMN)

Rate of detection of discontinuous (skip) lesions along the main pancreatic duct of patients with IPMN using intraoperative pancreatoscopy based on visual impression of IPMN and/or pancreatoscopy guided biopsies

Ability to advance the pancreatoscope along the entire main pancreatic duct length or until clinically needed; to visualize the potential lesion(s); or to obtain a tissue sample with SpyBite where applicable

Evaluate all serious adverse events related to the intraoperative pancreatoscopy procedure and/or device

Recurrence of IPMN within 5 years post-surgery evaluated with regular MRI or alternative radiological method

Comparison based on exploration with Spy Glass of the resected specimen

Based on intra-operative impression and on review of recorded pancreatoscopy images/videos

Boston Scientific Corporation

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Bile Duct Cancer

Spyglass + RFA

Cytobrush + RFA

Jianfeng Yang

With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time.The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.

Endoscopic retrograde cholangiopancreatography (ERCP) has been used as the primary method for the diagnosis of biliary strictures and the treatment of extrahepatic cholangiocarcinoma. However, the accurate visual diagnosis of malignant biliary strictures and assessment of the extent of a lesion are not possible by ERCP, and treatment of extrahepatic cholangiocarcinoma by ERCP procedures is sometimes difficult. In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time. Spyglass enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with radiofrequency ablation.Endoscopic radiofrequency ablation (RFA) is an emerging technique for the palliation of inoperable malignant biliary strictures (MBSs). In a dozen published studies, this novel approach has shown better safety and feasibility, as well as improvement in overall survival (OS). The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.

Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

Comparison of SpyGlass Guided RFA On The Same Stage Versus RFA After Cytobrush for Extrahepatic Cholangiocarcinoma

Incidence of Postoperative complications such as bleeding and infection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intra-operative Pancreatoscopy in Patients With IPMN	NCT03729453	Intraductal Pap...	SpyGlass	18 Years -	Boston Scientific Corporation
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma	NCT05233293	Extrahepatic Ch... Malignant Bilia...	Spyglass + RFA Cytobrush + RFA	18 Years -	First People's Hospital of Hangzhou
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma	NCT05233293	Extrahepatic Ch... Malignant Bilia...	Spyglass + RFA Cytobrush + RFA	18 Years -	First People's Hospital of Hangzhou

Spots Global Cancer Trial Database for spyglass

Every month we try and update this database with for spyglass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for spyglass

Every month we try and update this database with for spyglass cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for spyglass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.