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OpenTrials
Completed

NCT Number: NCT04886440

Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.

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Key information

Conditions

Lithiasis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz Thionville

Metz, Moselle, 57085, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient
  • Patient treated in CHR Metz-Thionville between 2013 and 2020
  • With a pathological impairment (suspected or confirmed) of a salivary gland
  • With sialendoscopy indication for diagnosis and/or treatment

Exclusion criteria

  • Opposed to use data
  • Without sialendoscopy indication
  • Without lithiasis salivary gland disorder
  • With parotid gland lithiasis

Treatment and study plan

Primary outcomes

  1. Recurrence of symptom

    Time frame: Month 6

    Absence or presence of symptoms associated to lithiasis

Secondary outcomes

  1. Number of clinical signs

    Time frame: Day 1

    number of clinical signs of the clinical suspicion

  2. Number of intraoperative complications

    Time frame: Day 1

    number of intraoperative complications

  3. Number of post-operative complications

    Time frame: Day 1

    Number of post-operative complications

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study

Acronym: SIAGLA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 14, 2021
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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