Safety and Accuracy of Minor Salivary Gland Biopsy in Sjoegren's Disease: A Retrospective Analysis of 202 Patients

Abstract

Objective Minor salivary gland biopsy (MSGB) is a standard procedure in the diagnosis of Sjögren’s disease (SD). Biopsy techniques using a vertical or horizontal mucosal incision are applied in daily practice. Here we aim to quantify and classify adverse events (AEs) of MSGB using vertical incision technique.

Patients and Methods Medical records of patients with suspected SD who underwent MSGB at our outpatient clinic between January 2014 and April 2024 and had follow-up visits were analyzed. The MSBG consisted of a 1 cm linear vertical incision in the oral mucosa of the lower lip to collect up to five lip salivary glands.

Results 202 of 257 patients undergoing MSGB, met inclusion criteria. Median follow-up time was 16.5 (0.5-124.0) months. Four biopsies (2%) did not yield sufficient material for histological analysis. One serious adverse event (0.5%), local persistent paresthesia, and two moderate adverse events (1.0%), including one case of prolonged bleeding and one unclassified event, were reported. Mild AEs occurred in 18 patients (8.9%). Local discomfort after biopsy affected 32 patients (15.8%). AEs subsided either during or up to 2 hours after biopsy in 14 patients (6.9%) and in 38 patients (18.8%) within three weeks, respectively.

Conclusions MSGB with vertical incision technique has a very low frequency of serious and long-term complications with a success rate of 98%.

Key messages

Minor salivary gland biopsy with lateral vertical incision technique has a success rate of 98%.

Serious complications occurred less frequent than previously reported for horizontal incision technique.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee of Mical University of Graz gave ethical approval for this work

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Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors

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