Establishing Standards for Normal Pancreatic EUS

NCT02868047 | Completed

• 1 other identifier: 21516
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

There is tremendous variability in regard to provider perception of findings on EUS for chronic pancreatitis. This study performs tandem EUS exams between expert endosonogrpahers to determine the validity of minimal standard criteria.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; endoscopic ultrasound

Outcome Measures

Primary Outcomes (9)

• Number of Patients with Hyperechoic Strands

  Day 1

• Number of Patients with Hyperechoic Foci

  Day 1

• Number of Patients with Lobular Contour

  Day 1

• Number of Patients with Cysts

  Day 1

• Number of Patients with Duct Irregularity

  Day 1

• Number of Patients with Ductal Calculi

  Day 1

• Number of Patients with Hyperechoic Duct Wall

  Day 1

• Number of Patients with Dilated Dilated Side Branches

  Day 1

• Number of Patients with Dilated Pancreatic Duct

  Day 1

Study Arms (2)

Suspected Chronic Pancreatitis

Included patients will be those scheduled for an upper endoscopic ultrasound examination with suspected chronic pancreatitis

Procedure: Endoscopic Ultrasound

NOT Suspected Chronic Pancreatitis

Included patients will be those scheduled for an upper endoscopic ultrasound examination without suspected chronic pancreatitis.

Procedure: Endoscopic Ultrasound

Interventions

Endoscopic Ultrasound PROCEDURE

Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis

NOT Suspected Chronic Pancreatitis; Suspected Chronic Pancreatitis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients who are scheduled for an elective EUS for evaluation of their pancreas. Patients will be those with and without suspected chronic pancreatitis.

You may qualify if:

• Undergoing upper EUS for evaluation of the pancreas

You may not qualify if:

• pregnancy
• age less than 18
• inability to provide written informed consent

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor, Department of Medicine

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: August 16, 2016
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: May 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)