Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in Cystic Tumors of the Pancreas

This study focuses on pancreatic cysts, especially malignant pancreatic cysts. The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making. For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by: Ruling out malignancy for patients with benign appearing nCLE images. Characterizing more malignant tumors in the pancreas.

Study Overview

• Status: Unknown
• Conditions: Cystic Tumors of Pancreas
• Intervention / Treatment: Diagnostic test: nCLE

Detailed Description

1. Medical background: Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes: pseudocysts, serous cysts and mucinous cystic neoplasms. Either intraductal papillary mucinous neoplasm (IPMN) or mucinous cyst adenomas / mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging.

2. Clinical background:

   2.1. Endoscopic Ultrasound (EUS) is the diagnostic method of choice when a pancreatic lesion is found incidentally on cross-sectional imaging. Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is a procedure where a target tissue in proximity to the GI tract is biopsied using a fine needle guided in real time by an ultrasound probe fixed at the tip of an endoscope. It may therefore be applied to pancreatic lesions, or lymph nodes examination.

   2.2. The principle of needle-based Confocal Laser Endomicroscopy (nCLE) is to image organs within or adjacent to the GI tracts with a miniprobe inserted through an endoscopic needle. The fundamental technology as well as the principle of operation of nCLE are substantially similar to pCLE.

3. Clinical evidence: Previous studies enabled to define interpretation criteria on the micro-structure of benign pancreatic cysts. Less data is available on malignant pancreatic cysts, except for a few images done in a pilot study of identification of pancreatic cystic neoplasms.

4. Objectives:

   4.1 The primary objective of the study is to assess the diagnostic performance of the Cellvizio nCLE system in diagnosing pancreatic cysts, when associated with other diagnostic information.

   4.2 The secondary objectives are to assess the potential impact of the Cellvizio nCLE system on patient management and validate the interpretation classification criteria that were created during the previous studies.

5. Design:

This study will be conducted in a single center in China.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aiming Yang, M.D.; Phone Number: +86-010-69151593; Email: yangaiming@medmail.com.cn
• Study Contact Backup: Name: Yunlu Feng, M.D.; Phone Number: +86-010-69151591; Email: yunluf@icloud.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Aiming Yang, M.D.; Phone Number: +86-10-69151593; Email: yangaiming@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female > 18 years of age.
• Patient indicated for a first EUS-FNA for a pancreatic cyst or
• Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst more than three months ago.
• Patient with known pancreatic cyst detected at cross-sectional imaging
• Willing and able to comply with study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

• Subjects for whom EUS-FNA procedures are contraindicated
• Known allergy to fluorescein dye
• If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pancreatic cysts	Diagnostic test: nCLE; Procedure: EUS-FNA Device: nCLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts	Diagnostic performance of the Cellvizio nCLE system compared with pathological results or consensus review at a multidisciplinary tumor board meeting	Within 6 months after the end of Follow-up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety data on nCLE during EUS-FNA procedure (rate of procedure related complication)	The rate of procedure related complication including bleeding, post-procedure pancreatitis and perforation	Within 3 months after the end of the enrollment period
Feasibility data on nCLE during EUS-FNA procedure (rate of successful nCLE procedure)	The rate of successful nCLE procedure	Within 3 months after the end of the enrollment period

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Aiming Yang, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: ZS-1265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No