SARcopenia in Patients With ChrOnic PANcreatitis: the SARCOPAN Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 98
- Locations
- 2
- Primary Endpoint
- whole body composition in chronic pancreatitis
Study Overview
Brief Summary
Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). Evidence of the prevalence and incidence of sarcopenia in chronic pancreatitis is lacking, as well as studies which correlate sarcopenia to evolution of chronic pancreatitis.The main aim of this study is to evaluate whole body composition, sarcopenia, dynamic force tests, laboratory data at different stages of chronic pancreatitis. The accuracy of bioimpedance analysis and muscle ultrasound in the diagnosis of sarcopenia will also be assessed.
Detailed Description
INTRODUCTION Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). It is associated with worse prognosis in terms of quality of life, morbidity, and mortality. Among causes of secondary sarcopenia, chronic inflammation, endocrine dysregulation, malnutrition, and malabsorption are some of the most important factors. All these conditions are present in chronic pancreatitis (CP) with or without endocrine or exocrine pancreatic insufficiency (EPI). Chronic pancreatitis is characterized by chronic inflammation of the gland, with acinar and ductal destruction and progressive replacement of injured pancreatic tissue by fibrotic tissue. As a result, pancreatic functions gradually decline and exocrine pancreatic insufficiency and pancreatogenic diabetes emerge. Evidence of the prevalence and incidence of sarcopenia in chronic pancreatitis is lacking, as well as studies which correlate sarcopenia to evolution of chronic pancreatitis. In a recent metanalysis, Kuan et la reported a prevalence of sarcopenia in CP ranging from 17 to 62%. Assessing sarcopenia and body composition in patients with chronic pancreatitis is an important prognostic factors as its impact on clinical outcome.The gold standard to diagnose sarcopenia is the measurement of muscle mass using computed tomography or magnetic resonance. Primary limitations of these procedures are the radiation exposure and costs, respectively. Muscle ultrasonography may be the ideal method for evaluating both muscle quality and quantity since it is inexpensive, easy to replicate, and unobtrusive. Different studies demonstrated a significant correlation between muscle ultrasound and muscle mass assessed with gold standard technique. To investigators' knowledge, no study has analysed the application of ultrasonography in the assessment of sarcopenia in chronic pancreatitis.
The main aim of this study is to evaluate whole body composition, sarcopenia, dynamic force tests, laboratory data at different stages of chronic pancreatitis. The accuracy of bioimpedance analysis and muscle ultrasound in the diagnosis of sarcopenia will also be assessed.
Materials and methods Ninety-eight patients with diagnosis of chronic pancreatitis will be enrolled in this prospective study. Inclusion criteria are age between 18 and 65 years, and CT, or MRI into precedent maximum 12 months. Exclusion criteria include age less than 18 or older than 65 and lack of informed consent.
Based on CT and MRI, CP will be classified according to Cambridge classification. Diagnosis of EPI will be defined according to fecal elastase <200 mg/g .
Serum nutritional markers associated with CP and PEI amylase, lipase, vitamin D, vitamin B12, folate, total protein, albumin, total cholesterol, HDL cholesterol, triglycerides will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •written informed consent
- •diagnosis of chronic pancreatitis
- •age between 18 and 65 years,
- •abdominal CT or MRI into precedent maximum12 months.
Exclusion Criteria
- •age less than 18 or older than 65 years
- •lack of informed consent.
Outcomes
Primary Outcomes
whole body composition in chronic pancreatitis
Time Frame: three months
measurement of skeletal muscle mass through bioelectrical impedance
dynamic muscle force
Time Frame: three months
Handgrip strength test using a hydraulic hand dynamometer
sarcopenia prevalence in chronic pancreatitis
Time Frame: three months
skeletal muscle index (SMI) = skeletal muscle Area (SMA)/height
Secondary Outcomes
No secondary outcomes reported
