Brief Summary

The study is based on a multi-center approach of needle based confocal laser endomicroscopy (nCLE) combined with endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (FNA) to evaluate pancreatic cystic lesions (PCL), in order to obtain a correct histopathological diagnosis.After detection of PCL, certain morphological EUS features allow the discrimination of specific cyst types. Additionally, EUS-FNA is recommended as the first-line procedure whenever pathological diagnosis is required; however the procedure has its drawbacks, mainly represented by the relatively low negative predictive value in diagnosing pancreatic cancer. In this case a more precisely diagnostic tool is required; the potential role of CLE has been explored in gastrointestinal (GI) pathology showing good accuracy for predicting the final histopathological diagnosis based on immediate evaluation of tissue and vascular patterns. Although the clinical impact of nCLE for the decision making algorithms in cystic pancreatic neoplasm has not yet been described, the hypothesis is that EUS-nCLE could allow targeted tissue sampling of cystic pancreatic neoplasms resulting in more accurate diagnosis. The aim of the study is to describe the clinical impact of nCLE for the clinical decision management algorithm based on EUS, EUS-FNA and/or EUS-CLE imaging criteria for cystic pancreatic neoplasms, while evaluating also the feasibility and safety of nCLE examination.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Jun 2015

Geographic Reach

4 countries

8 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

June 1, 2015

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed

17 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed

Last Updated

January 17, 2018

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

June 23, 2015

Last Update Submit

January 15, 2018

Conditions

Pancreatic Cysts Pancreatic Mucinous-Cystic Neoplasm Intraductal Papillary Mucinous Neoplasm Solid Pseudopapillary Tumour of the Pancreas Cystadenocarcinoma Serous Cystadenoma

Outcome Measures

Primary Outcomes (1)

Accuracy of EUS-guided nCLE in a cohort of cystic pancreatic tumors
Final diagnosis reached by surgical pathology and/or follow-up
6 months

Secondary Outcomes (1)

Number of participants with adverse events as a measure of safety
1 month

Study Arms (5)

Serous cystadenoma

Serous cystadenoma patients. Endoscopic ultrasound guided needle based confocal endomicroscopy will be applied in all patients.