Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study
Introduction We established a promising sialendoscopic treatment for in vivo enhancement of salivation in salivary glands affected by Sjögren’s syndrome (SS). In this technique, the ducts of the salivary glands are irrigated with saline and steroids. This allows for dilatation of ductal strictures a...
Saved in:
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e033542.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1841554652669149184 |
|---|---|
| author | Arjan Vissink K Hakki Karagozoglu Tim Forouzanfar Henk S Brand Derk Hendrik Jan Jager Marco Helder Joseph Bot Otto Kamp Seunghee Cha Gary Weisman Imke Bartelink |
| author_facet | Arjan Vissink K Hakki Karagozoglu Tim Forouzanfar Henk S Brand Derk Hendrik Jan Jager Marco Helder Joseph Bot Otto Kamp Seunghee Cha Gary Weisman Imke Bartelink |
| author_sort | Arjan Vissink |
| collection | DOAJ |
| description | Introduction We established a promising sialendoscopic treatment for in vivo enhancement of salivation in salivary glands affected by Sjögren’s syndrome (SS). In this technique, the ducts of the salivary glands are irrigated with saline and steroids. This allows for dilatation of ductal strictures and removal of debris. Unfortunately, it is not possible to assess the delivery and penetration of saline or medications in the ductal system and parenchyma. To address this problem, we will conduct contrast-enhanced ultrasound sialendoscopy (CEUSS) using sulphur hexafluoride microbubbles. To the best of our knowledge, microbubbles have never been used for the treatment of salivary glands in SS. It is, therefore, imperative to test this application for its safety and feasibility.Methods and analysis A single-arm phase I study will be performed in 10 SS patients. Under local anaesthesia, ultrasound (US) guided infusion of the parotid and submandibular glands with microbubbles will be performed. Continuous US imaging will be used to visualise the glands, including the location of strictures and occlusions. Main outcomes will be the evaluation of safety and technical feasibility of the experimental treatment. Secondary outcomes will consist of determinations of unstimulated whole mouth saliva flow, stimulated whole mouth saliva flow, stimulated parotid saliva flow, clinical oral dryness, reported pain, xerostomia, disease activity, salivary cytokine profiles and clinical SS symptoms. Finally, salivary gland topographical alterations will be evaluated by US.Ethics and dissemination Ethical approval for this study was obtained from the Medical Ethics Committee of the Amsterdam University Medical Centre, Amsterdam, The Netherlands (NL68283.029.19). data will be presented at national and international conferences and published in a peer-reviewed journal. The study will be implemented and reported in line with the Standard Protocol Items: Recommendations for Interventional Trials’ statement.Trial registration numbers The Netherlands Trial Register: NL7731, MREC Trial Register: NL68283.029.19; Pre-results. |
| format | Article |
| id | doaj-art-aa58c41dc5ac4da099a88078e97d021d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-aa58c41dc5ac4da099a88078e97d021d2025-01-08T12:20:08ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-033542Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory studyArjan Vissink0K Hakki Karagozoglu1Tim Forouzanfar2Henk S Brand3Derk Hendrik Jan Jager4Marco Helder5Joseph Bot6Otto Kamp7Seunghee Cha8Gary Weisman9Imke Bartelink102 Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The NetherlandsAmsterdam UMC and Academic Centre for Dentistry Amsterdam (ACTA), Oral and Maxillofacial Surgery/Oral Pathology, De Boelelaan 1117, Amsterdam, The NetherlandsDepartment of Oral and Maxillofacial Surgery / Oral Pathology, Amsterdam University Medical Center (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Oral Biochemistry, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, The NetherlandsDepartment of Oral and Maxillofacial Surgery / Oral Pathology, Amsterdam University Medical Center (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Oral and Maxillofacial Surgery / Oral Pathology, Amsterdam University Medical Center (Amsterdam UMC, Location VUmc) and Academic Centre for Dentistry Amsterdam (ACTA), Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Radiology and Nuclear Medicine, Amsterdam University Medical Center (Amsterdam UMC, Location VUmc), Vrije Universiteit Amsterdam, Amsterdam, The Netherlands3Amsterdam University Medical Center, location VUmc, Department of Cardiology, Amsterdam, NetherlandsOral Medicine, University of Florida, Gainesville, Florida, USADepartment of Biochemistry, MU Bond Life Sciences Center, University of Missouri, Columbia, Missouri, USADepartment of Clinical Pharmacology and Pharmacy, Amsterdam University Medical Center (Amsterdam UMC, Location VUmc), Amsterdam, The NetherlandsIntroduction We established a promising sialendoscopic treatment for in vivo enhancement of salivation in salivary glands affected by Sjögren’s syndrome (SS). In this technique, the ducts of the salivary glands are irrigated with saline and steroids. This allows for dilatation of ductal strictures and removal of debris. Unfortunately, it is not possible to assess the delivery and penetration of saline or medications in the ductal system and parenchyma. To address this problem, we will conduct contrast-enhanced ultrasound sialendoscopy (CEUSS) using sulphur hexafluoride microbubbles. To the best of our knowledge, microbubbles have never been used for the treatment of salivary glands in SS. It is, therefore, imperative to test this application for its safety and feasibility.Methods and analysis A single-arm phase I study will be performed in 10 SS patients. Under local anaesthesia, ultrasound (US) guided infusion of the parotid and submandibular glands with microbubbles will be performed. Continuous US imaging will be used to visualise the glands, including the location of strictures and occlusions. Main outcomes will be the evaluation of safety and technical feasibility of the experimental treatment. Secondary outcomes will consist of determinations of unstimulated whole mouth saliva flow, stimulated whole mouth saliva flow, stimulated parotid saliva flow, clinical oral dryness, reported pain, xerostomia, disease activity, salivary cytokine profiles and clinical SS symptoms. Finally, salivary gland topographical alterations will be evaluated by US.Ethics and dissemination Ethical approval for this study was obtained from the Medical Ethics Committee of the Amsterdam University Medical Centre, Amsterdam, The Netherlands (NL68283.029.19). data will be presented at national and international conferences and published in a peer-reviewed journal. The study will be implemented and reported in line with the Standard Protocol Items: Recommendations for Interventional Trials’ statement.Trial registration numbers The Netherlands Trial Register: NL7731, MREC Trial Register: NL68283.029.19; Pre-results.https://bmjopen.bmj.com/content/10/9/e033542.full |
| spellingShingle | Arjan Vissink K Hakki Karagozoglu Tim Forouzanfar Henk S Brand Derk Hendrik Jan Jager Marco Helder Joseph Bot Otto Kamp Seunghee Cha Gary Weisman Imke Bartelink Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study BMJ Open |
| title | Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study |
| title_full | Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study |
| title_fullStr | Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study |
| title_full_unstemmed | Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study |
| title_short | Intraoperative visualisation and treatment of salivary glands in Sjögren’s syndrome by contrast-enhanced ultrasound sialendoscopy (CEUSS): protocol for a phase I single-centre, single-arm, exploratory study |
| title_sort | intraoperative visualisation and treatment of salivary glands in sjogren s syndrome by contrast enhanced ultrasound sialendoscopy ceuss protocol for a phase i single centre single arm exploratory study |
| url | https://bmjopen.bmj.com/content/10/9/e033542.full |
| work_keys_str_mv | AT arjanvissink intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT khakkikaragozoglu intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT timforouzanfar intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT henksbrand intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT derkhendrikjanjager intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT marcohelder intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT josephbot intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT ottokamp intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT seungheecha intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT garyweisman intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy AT imkebartelink intraoperativevisualisationandtreatmentofsalivaryglandsinsjogrenssyndromebycontrastenhancedultrasoundsialendoscopyceussprotocolforaphaseisinglecentresinglearmexploratorystudy |