RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)

NCT04001556 | Completed

• 1 other identifier: 35RC18_9905
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief Summary

As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Ultrasonography characteristics of major salivary glands

  Ultrasonography characteristics of major salivary glands based on Salaffi's composite score. each MSG will be scored as followed: * grade 0 = normal homogeneous glands; * grade 1 = Homogenous borders, slightly heterogeneous parenchyma, * grade 2 = Homogenous borders, multiple hypoechogenic areas measuring \< 2 mm, * grade 3 = multiple hypoechogenic areas measuring 2-6 mm or irregular borders or invisible posterior part of the gland; * grade 4 = unstructured glandular parenchyma with multiple hypoechogenic areas measuring \>6 mm or calcifications with echogenic bands. In each patient, 4 grades can be obtained (1 grade per gland); the sum of these 4 grades (range 0-16) will be the Salaffi's score. A score of 0 has the best outcome, of 16 the worse

  up to six months (at evaluation visit)

• Ultrasonography characteristics of major salivary glands

  Ultrasonography characteristics of major salivary glands based on bilateral ARFI(Acoustic radiation force Impulse) elastometry

  up to six months (at evaluation visit)

Secondary Outcomes (12)

• Variants of the Salaffi score

  up to six months (evaluation visit)

• Variants of the Salaffi score

  up to six months (evaluation visit)

• Variants of the Salaffi score

  up to six months (evaluation visit)

• Biopsy of the minor salivary glands

  up to six months (evaluation visit)

• Biopsy of the minor salivary glands

  up to six months (evaluation visit)

Study Arms (2)

Patients reporting subjective sicca symptoms

EXPERIMENTAL

HAQ(Health Assessment Questionnaire) Score, bilateral schirmer 's test, unstimulated whole salivary flow rate, blood sample for immunologic evaluation

Diagnostic Test: Minor Salivary gland Biopsy; Diagnostic Test: ARFI; Diagnostic Test: MSG US

Patients without subjective sicca symptoms

EXPERIMENTAL

HAQ(Health Assessment Questionnaire) score, bilateral schirmer 's test, unstimulated whole salivary flow rate, blood sample for immunologic evaluation

Diagnostic Test: ARFI; Diagnostic Test: MSG US

Interventions

Minor Salivary gland Biopsy DIAGNOSTIC_TEST

Minor salivary gland biopsy with injection of lidocain

Patients reporting subjective sicca symptoms

ARFI DIAGNOSTIC_TEST

Acoustic Radiation Force Impulse on Major Salivary Glands

Patients reporting subjective sicca symptoms; Patients without subjective sicca symptoms

MSG US DIAGNOSTIC_TEST

Ultrasonography of Major Salivary Glands

Patients reporting subjective sicca symptoms; Patients without subjective sicca symptoms

Eligibility Criteria

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

You may qualify if:

• Patients over eighteen years old;
• Fulfilling 2013 ACR classification criteria for Systemic sclerosis (Van den Hoogen et al. 2013);
• patients with subjective sicca symptoms reported by a standardised questionnaire (Vitali C et al. 2002);
• patients without sicca symptoms;
• Who has signed an informed consent
• Benefiting from a social security scheme

You may not qualify if:

• Treatment: current (or in the past 6 months) immunosuppressive treatment by rituximab or cyclophosphamide (representing less than 5% of SSc patients in the investigator's centres);
• Current (or in the past 6 months) treatment with drugs with anti-cholinergic properties (Selective Serotonin Reuptake Inhibitors and anti-histaminic inhibitors (hydroxyzine));
• Current treatment with antiplatelet aggregates
• Anti-vitamin K treatment (increasing risk of bleeding during minor salivary gland biopsy); and oral anti-coagulant
• Known abnormal coagulation (prolonged aPPT(activated partial thromboplastin time) and / or PT (Prothrombin time ( \<70%)), or known thrombocytopenia (\<150,000 platelets / mm3)
• Known secondary sicca symptoms : history of head-and-neck radiotherapy, hepatitis C infection, AIDS, sarcoidosis, amyloidosis, graft-vs-host disease and IgG4(Isotype's immunoGlobulin G4)-related disease;
• Pregnancy or breastfeeding mothers;
• Known intolerance/allergy to xylocain injection;
• Adults legally protected (under judicial protection, guardianship, or supervision), inability to consent.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (3)

CHU Brest Service de Rhumatologie

Brest, 29000, France

Location

CHU rennes

Rennes, 35000, France

Location

CHU Tours, Service de médecine interne

Tours, 37000, France

Location

Related Publications (5)

• Salaffi F, Argalia G, Carotti M, Giannini FB, Palombi C. Salivary gland ultrasonography in the evaluation of primary Sjogren's syndrome. Comparison with minor salivary gland biopsy. J Rheumatol. 2000 May;27(5):1229-36.

  PMID: 10813292 BACKGROUND

• Hocevar A, Ambrozic A, Rozman B, Kveder T, Tomsic M. Ultrasonographic changes of major salivary glands in primary Sjogren's syndrome. Diagnostic value of a novel scoring system. Rheumatology (Oxford). 2005 Jun;44(6):768-72. doi: 10.1093/rheumatology/keh588. Epub 2005 Mar 1.

  PMID: 15741192 BACKGROUND

• Milic VD, Petrovic RR, Boricic IV, Radunovic GL, Pejnovic NN, Soldatovic I, Damjanov NS. Major salivary gland sonography in Sjogren's syndrome: diagnostic value of a novel ultrasonography score (0-12) for parenchymal inhomogeneity. Scand J Rheumatol. 2010 Mar;39(2):160-6. doi: 10.3109/03009740903270623.

  PMID: 20059370 BACKGROUND

• Jousse-Joulin S, Milic V, Jonsson MV, Plagou A, Theander E, Luciano N, Rachele P, Baldini C, Bootsma H, Vissink A, Hocevar A, De Vita S, Tzioufas AG, Alavi Z, Bowman SJ, Devauchelle-Pensec V; US-pSS Study Group. Is salivary gland ultrasonography a useful tool in Sjogren's syndrome? A systematic review. Rheumatology (Oxford). 2016 May;55(5):789-800. doi: 10.1093/rheumatology/kev385. Epub 2015 Dec 14.

  PMID: 26667216 BACKGROUND

• Cornec D, Jousse-Joulin S, Pers JO, Marhadour T, Cochener B, Boisrame-Gastrin S, Nowak E, Youinou P, Saraux A, Devauchelle-Pensec V. Contribution of salivary gland ultrasonography to the diagnosis of Sjogren's syndrome: toward new diagnostic criteria? Arthritis Rheum. 2013 Jan;65(1):216-25. doi: 10.1002/art.37698.

  PMID: 23108632 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Patrick JEGO, MD

  University Hospital of Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The examiner performin the evaluation of ultrasound features of the main salivary glands will not have acess at the first part of patient evaluation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cross-sectionnal pilot study

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: June 28, 2019
• Study Start: December 2, 2019
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

FR (3)