Position-Guided Nasopharyngeal Irrigation for Post-Radiotherapy Ulcer Care in Nasopharyngeal Carcinoma

Summary

This protocol describes how to perform position-guided nasopharyngeal irrigation for post-radiotherapy ulcer care in nasopharyngeal carcinoma. It details device setup, catheter positioning, low-pressure saline delivery, drainage, and aseptic handling to enable standardized and reproducible irrigation in clinical and home settings.

Abstract

To describe and standardize a position-guided nasopharyngeal irrigation protocol for post-radiotherapy nasopharyngeal ulceration (RINU) in patients with nasopharyngeal carcinoma (NPC), a prospective comparative clinical setting was used among 184 patients diagnosed with RINU between January and March 2025. Participants were randomly assigned to receive either routine manual irrigation (n = 92) or irrigation using an improved position-guided device (n = 92). The protocol incorporates an anatomically guided, double-lumen catheter with a direction-controlled tip, an adjustable outer sheath, and a low-pressure manual pump system operating at 50-100 mmHg, enabling controlled saline delivery with simultaneous drainage. Core procedural elements include catheter positioning relative to the nasopharyngeal vault, regulation of irrigation pressure and flow, sequencing of irrigation cycles, and management of continuous outflow to minimize fluid retention. The protocol was applied in a clinical setting with evaluations performed at baseline, 1 month, and 2 month using standardized endoscopic grading of mucosal injury, assessment of secretion viscosity, bacterial culture testing, pain measured by the visual analog scale (VAS), and comfort assessed by the General Comfort Questionnaire (GCQ). Baseline demographic and clinical characteristics were comparable between groups. During follow-up, differences were observed between groups in mucosal healing status, secretion characteristics, microbiological findings, and patient-reported symptom measures, with statistically significant between-group differences across endpoints (all p < 0.05). Endoscopic examinations documented granulation and epithelialization patterns over time, and no severe adverse events were observed during protocol application. This protocol describes a reproducible, standardized framework for position-guided nasopharyngeal irrigation in the post-radiotherapy management of RINU.

Introduction

Nasopharyngeal carcinoma (NPC) is a unique malignancy arising from the epithelial lining of the nasopharynx, with a remarkably unbalanced geographic distribution. It is highly prevalent in southern China and Southeast Asia, where Epstein-Barr virus (EBV) infection, genetic susceptibility, and environmental co-factors contribute to its pathogenesis¹. Owing to its deep anatomic location and radiosensitive histology, radiotherapy, particularly intensity-modulated radiotherapy (IMRT), remains the mainstay of curative treatment for non-metastatic NPC². With the advent of IMRT and concurrent chemoradiotherapy, locoregional con....

Protocol

This study was conducted in accordance with the ethical principles of the Declaration of Helsinki and the institutional regulations governing human research. The research protocol was reviewed and approved by the Institutional Review Board of The First Affiliated Hospital of Hainan Medical University (Approval ID: 2025-KYL-158). Written informed consent was obtained from all participants prior to enrollment. The study was prospectively registered and implemented under continuous ethical supervision. All participants received psychological counseling and pain management education prior to enrollment to reduce anxiety and discomfort related to repeated irrigation. No pa....

Results

Baseline demographic and clinical characteristics demonstrated group comparability
A total of 184 patients diagnosed with RINU secondary to NPC were enrolled between January and March 2025. All participants were randomly assigned in a 1:1 ratio to the control group (routine irrigation, n = 92) or the intervention group (position-guided irrigation, n = 92), completed the 2 month treatment and follow-up, and were included in the final analysis (Figure 1). All randomized pa.......

Discussion

This prospective comparative study examined differences in mucosal healing, secretion characteristics, pain scores, and comfort measures between patients receiving position-guided nasopharyngeal irrigation and those receiving conventional manual irrigation. Over an 8 week treatment period, a complete or near-complete mucosal healing rate of 89.1% was observed in the position-guided irrigation group, compared with 69.6% in the routine irrigation group. These findings suggest that a precisely controlled, anatomically guide.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Adjustable outer sheath	Engineering Laboratory, Jiangxi Cancer Hospital, China	JCH-SH-2023	Provides directional and depth control for targeted irrigation
Bacterial culture media (Blood agar, MacConkey agar)	Oxoid, UK	CM0055 / CM0007	For microbiological analysis of secretions
Computer workstation	Lenovo ThinkStation P620	Win10Pro-22H2	Workstation for data processing and analysis
Digital camera system	Sony Medical Imaging, Japan	ILCE-7RM4	Used for image capture of endoscopic and clinical findings
Disposable sterile gloves	3M Healthcare, USA	1860	Used during all irrigation and device handling procedures
Ethanol solution (75%)	Sinopharm Chemical Reagent Co., Ltd., China	10009218	Used for device disinfection
General Comfort Questionnaire (GCQ)	Kolcaba Comfort Research Foundation	RRID:SCR_016653	Validated scale measuring comfort in four domains
GraphPad Prism Version 9.5.1 (733)	GraphPad Software, USA	RRID:SCR_002798	Used for figure plotting and statistical visualization
Improved position-guided nasopharyngeal irrigation device	Engineering Laboratory, Jiangxi Cancer Hospital, China	JCH-PGNI-2023	Double-lumen catheter system with directional tip, adjustable outer sheath, and manual low-pressure pump (50–100 mmHg); reusable after sterilization
Incubator (37 °C)	Thermo Fisher Scientific, USA	51028144	For incubation of bacterial cultures
Manual squeeze bulb / low-pressure pump	Jiangsu Huaxin Medical Equipment Co., Ltd., China	HX-20	Maintains steady irrigation pressure (50–100 mmHg)
Medical-grade flexible catheter (1.5–2.0 mm × 8–10 cm)	Well Lead Medical Co., Ltd., China	880200	Inner catheter with atraumatic rounded tip to prevent mucosal injury
Medical-grade monitor	Philips Healthcare, Netherlands	272B8QJ	Used for endoscopic visualization
Nasal endoscope (0°/30° rigid type)	Karl Storz, Germany	7200AA / 7210AA	Used for visual guidance during irrigation and ulcer assessment
Nasopharyngeal secretion collection swab	Copan Diagnostics, Italy	480CE	Used for bacterial culture sampling
Needle-free connector	BD Medical, USA	302204	Connects irrigation catheter to sterile saline reservoir
PASS Software Version 15.0 (Build 15.0.5)	NCSS LLC, USA	15.0.5	Used for power and sample size analysis
Patient treatment logbook	Clinical Research Documentation Unit, Jiangxi Cancer Hospital	LOG-2023-JCH	Daily record of irrigation frequency and adverse events
SPSS Statistics Version 27.0	IBM Corp., USA	RRID:SCR_002865	Used for statistical analysis and data management
Sterile 0.9% saline solution	Baxter Healthcare, USA	2B1323	Used for irrigation; pre-warmed (35–37 °C)
Sterile drape set	Medline Industries, USA	DYNJP2425	Provides sterile field for nasopharyngeal irrigation
Sterile water	China National Pharmaceutical Group	110125	Used to rinse components after disinfection
Surgical mask	3M Healthcare, USA	1870+	Used to maintain aseptic conditions
Telemedicine video consultation platform	WeDoctor Telehealth Platform, China	v3.2.1	Used for remote follow-up and adherence monitoring
Visual Analog Scale (VAS) Pain Form	Jiangxi Cancer Hospital Clinical Research Unit	RRID:SCR_016655	0–10 scale for subjective pain assessment