Elastography in the Diagnosis of Chronic Pancreatitis

NCT03173118 | Completed

• 1 other identifier: STH19471
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pancreatitis is a progressive inflammatory condition where progressive fibrosis and calcification results in loss of physiological pancreatic function (both endocrine and exocrine). The structural, fibrotic changes of chronic pancreatitis can only be seen in advanced disease with conventional radiology tests and the diagnosis of chronic pancreatitis early in the disease course remains challenging. Early diagnosis and treatment of chronic pancreatitis can prevent the complications of pain and malnutrition and improve the quality of life of patients. Endoscopic ultrasound (EUS) has recently become a favoured method for diagnosing early structural fibrotic changes of chronic pancreatitis in clinical practice; however this technique is subjective with sub-optimal intra-observer agreement. A new technique called elastography, performed during EUS, quantitatively measures tissue stiffness which may give more reliable results. This study aims to assess whether EUS elastography can accurately identify for chronic pancreatitis. Patients referred for EUS examinations will be identified and recruited prospectively. The investigators will perform endoscopic ultrasound examinations with elastography readings in two groups of patients: those referred for EUS with suspicion of chronic pancreatitis and those referred for EUS for assessment of abdominal pain without risk factors or any other tests suggesting chronic pancreatitis. The elastography readings will then be compared to the gold standard which is a composite evaluation including standard EUS examination using morphological appearance (Rosemont classification), and other tests already performed including cross-sectional imaging (MRCP and CT), patient history and faecal pancreatic elastase (FEL-1). Patients will be identified and data collected prospectively. There is no randomization or blinding involved in the study as the endoscopists will need to be aware of the indication for referral in order to carry out a complete examination.

Conditions

Pancreatitis, Chronic

Outcome Measures

Primary Outcomes (1)

• Elastography strain ratios

  The primary outcome measure for this study will be Elastography strain ratios in patients found to have changes consistent with chronic pancreatitis on conventional EUS Rosemont criteria or other investigations and those without

  through study completion which will be a maximum of one hour

Study Arms (2)

suspected chronic pancreatitis patients

OTHER

Patients with suspected chronic pancreatitis will undergo Endoscopic ultrasound elastography to assess whether this detects chronic pancreatitis.

Procedure: Endoscopic ultrasound elastography

Assessment of abdominal pain patients

OTHER

Patients who are referred for assessment of abdominal pain without risk factors or any other tests suggesting chronic pancreatitis will undergo Endoscopic ultrasound elastography

Procedure: Endoscopic ultrasound elastography

Interventions

Endoscopic ultrasound elastography PROCEDURE

Endoscopic ultrasound elastography performed on both groups of patients as per routine

Assessment of abdominal pain patients; suspected chronic pancreatitis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or over,
• Patients referred for EUS for investigation of abdominal pain without a cause found on assessment with MRI and FEL-1.
• Patients referred for EUS for chronic pancreatitis assessment based on MRI and/or FEL-1 testing.

You may not qualify if:

• Patients with known solid pancreatic lesions
• Patients under the age of 18
• Patients who decline EUS examination
• Patients referred for EUS with indications other than epigastric pain or suspicion of chronic pancreatitis

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jennifer Campbell

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 1, 2017
• Study Start: November 29, 2016
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)