NCT04886440

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

May 10, 2021

Last Update Submit

August 30, 2022

Conditions

Lithiasis

Keywords

sialendoscopysubmandibular glandclassification

Outcome Measures

Primary Outcomes (1)

  • Recurrence of symptom

    Absence or presence of symptoms associated to lithiasis

    Month 6

Secondary Outcomes (3)

  • Number of clinical signs

    Day 1

  • Number of intraoperative complications

    Day 1

  • Number of post-operative complications

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with submandibular sialolithiasis

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

Lithiasis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 14, 2021

Study Start

January 1, 2021

Primary Completion

March 25, 2021

Study Completion

March 25, 2021

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

FR(1)