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Elastography in the Diagnosis of Chronic Pancreatitis

NCT03173118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-04-24

No results posted yet for this study

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

Interventions

PROCEDURE

Endoscopic ultrasound elastography

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

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Jennifer Campbell · Sheffield Teaching Hospitals NHS FT

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-29
Primary Completion
2019-11-29
Completion
2019-11-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03173118 on ClinicalTrials.gov