A Lip Fixation Device Facilitates Labial Salivary Gland Biopsy for Sjögren's Disease.

The protocol aims to standardize and simplify labial salivary gland biopsy (LSGB) in suspected Sjögren's disease (SjD) using a lip fixation device, enabling safe, efficient, and operator-independent procedures with reduced technical difficulty, especially for junior rheumatologists. We developed a step-by-step protocol encompassing preoperative assessment, antisepsis, local anesthesia, device-assisted lip stabilization, precise vertical incision (5-7 mm), blunt dissection, gland harvesting (minimum 4-6 glands), and standardized closure. The device consists of two clamp arms, an oval pressure ring (major axis 2.4 cm, minor axis 1.5 cm), a matching backing plate separated by a 2.1 cm gap, and a precision screw mechanism. After the patient was positioned supine on the bed, clinical inspection was performed, followed by a "go/no-go" assessment to exclude localized active infection, mucosal ulceration, significant debris, or lip masses. Triple antisepsis is performed with alcohol-free Type III povidone-iodine. Local infiltration anesthesia is administered away from the incision site. The lip is everted and stabilized by the device; a vertical incision is made parallel to the pressure ring axis, penetrating the epithelium while avoiding deep glands or muscle. Glands are identified as pale-yellow translucent spherules (1-2 mm) and harvested by blunt dissection. Closure is achieved with a single interrupted suture, and hemostasis is verified. The protocol enables solo performance, reduces procedure time compared with conventional methods (8.72 ± 1.88 min vs. 18.11 ± 2.65 min, p < 0.001), yields comparable complication rates between groups (all p > 0.05), and ensures acquisition of adequate tissue (>8 mm², focus score assessment feasible). The device's elastic compression prevents tissue injury despite secure stabilization, and predefined troubleshooting steps manage bleeding or suboptimal yield. This protocol standardizes LSGB with a fixation device, overcoming manual retraction challenges, reducing reliance on assistants, and supporting training and quality assurance in rheumatology, while maintaining diagnostic accuracy and patient safety.