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CompletedNCT04886440SIAGLAUpdated Aug 31, 2022

Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis

An observational study in Lithiasis, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
138
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lithiasis

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Keywords

  • sialendoscopy
  • submandibular gland
  • classification
03

In context

Lithiasis

11 studies on the registry are indexed under Lithiasis; 2 are open to participants now.

Browse Lithiasis studies →

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with submandibular sialolithiasis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
138 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Recurrence of symptom

    Absence or presence of symptoms associated to lithiasis

    Time frame: Month 6

Secondary outcomes

  1. Number of clinical signs

    number of clinical signs of the clinical suspicion

    Time frame: Day 1

  2. Number of intraoperative complications

    number of intraoperative complications

    Time frame: Day 1

  3. Number of post-operative complications

    Number of post-operative complications

    Time frame: Day 1

07

Study locations

1 site
  • CHR Metz Thionville
    Metz, Moselle 57085, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2021 to primary completion in Mar 2021, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2021
First posted
May 14, 2021
StartActual
Jan 1, 2021
Primary completionActual
Mar 25, 2021
CompletionActual
Mar 25, 2021
Last update
Aug 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04886440
Responsible party
Sponsor
First posted
May 14, 2021
Start date
Jan 1, 2021
Primary completion
Mar 25, 2021
Completion
Mar 25, 2021
Last update
Aug 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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