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Clinical Trials/NCT06092307
NCT06092307RecruitingNot Applicable

SARcopenia in Patients With ChrOnic PANcreatitis: the SARCOPAN Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 sites in 1 country98 target enrollmentStarted: April 18, 2023Last updated:
Conditions

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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