Clinical research of endoscopic antireflux mucosal ablation in treating gastroesophageal reflux disease

doi:10.3877/cma.j.issn.2095-8765.2026.01.002

Abstract

Abstract:

Objective

To compare the short-term efficacy and safety of endoscopic antireflux mucosal ablation (ARMA) versus an optimized, guideline-based step-up proton pump inhibitor (PPI) regimen in patients with refractory or PPI-dependent gastroesophageal reflux disease (GERD) classified as gastroesophageal flap valve (GEFV) grade Ⅰ-Ⅲ.

Methods

A prospective, randomized, open-label, active-controlled trial was designed. Fifty patients were planned to be recruited and randomly assigned (1:1) to either the ARMA group or the optimized PPI group. The primary endpoint was the change from baseline in GERD health-related quality of life (GERD-HRQL) score at 6 months post-treatment. Secondary endpoints included symptom scores (GERD-Q), acid exposure time (AET) percentage, DeMeester score, PPI usage status, and adverse events. A prespecified subgroup analysis based on GEFV grade (Ⅰ/Ⅱ vsⅢ) was conducted.

Results

Forty-eight patients completed the 6-month follow-up and were included in the analysis. The improvement in GERD-HRQL score was significantly greater in the ARMA group than in the optimized PPI group (median improvement: 23.5 vs 8.0, P<0.001). Analysis of secondary endpoints showed that the ARMA group was significantly superior to the optimized PPI group in improving objective reflux parameters such as AET (decreased from 20.1% to 4.6%) and DeMeester score, as well as in promoting PPI discontinuation or dose reduction (all P <0.001). Preliminary subgroup analysis showed that the efficacy of ARMA in improving GERD-HRQL was superior to optimized PPI in both GEFV I/II and Ⅲ grade patients (all P<0.05). Treatment-related adverse events occurred in 12.5% (3/24) of patients in the ARMA group, all of which were mild and transient dysphagia.

Conclusion

For patients with refractory GERD and GEFV grade Ⅰ-Ⅲ, ARMA is significantly superior to systematic optimized PPI therapy in improving symptoms, quality of life, and objective reflux parameters within 6 months, with a good safety profile. ARMA provides an effective minimally invasive therapeutic option for patients who remain symptomatic despite adequately optimized medical therapy or who wish to avoid long-term medication dependence.

Key words: Gastroesophageal reflux disease, Endoscopic antireflux mucosal ablation, Proton pump inhibitor, Randomized controlled trial, Gastroesophageal flap valve grade

Yan Chen, Yongjian Gu, Si Chen, Hongguang Wang, Qingmei Guo, Liying Tao, Jiwei Zhang, Lianyu Piao, Libin Ruan, Yufang Zhou, Chong Pang, Xiang Guo. Clinical research of endoscopic antireflux mucosal ablation in treating gastroesophageal reflux disease[J]. Chinese Journal of Gastroesophageal Reflux Disease(Electronic Edition), 2026, 13(01): 8-15.

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Figures/Tables 6

References 19

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级别	管理方案
0	无PPI治疗
1	标准剂量半量PPI
2	标准剂量PPI（既往有效）
3	双倍剂量（2次/d），适用于标准剂量治疗2个月后症状仍控制不佳者
4	每2个月递增1个标准剂量，逐步增至三倍剂量（2清晨，1睡前），若仍无效可增至四倍剂量（2次/d）

级别	管理方案
0	无PPI治疗
1	标准剂量半量PPI
2	标准剂量PPI（既往有效）
3	双倍剂量（2次/d），适用于标准剂量治疗2个月后症状仍控制不佳者
4	每2个月递增1个标准剂量，逐步增至三倍剂量（2清晨，1睡前），若仍无效可增至四倍剂量（2次/d）

组别	例数	性别		LA分级			GEFV分级			裂孔疝
组别	例数	男性	女性	A	B	C	I	II	Ⅲ	裂孔疝
ARMA组	24	18（75）	6（25）	8（33.33）	7（29.17）	9（37.5）	9（37.5）	10（41.67）	5（20.83）	12（50）
PPI组	24	18（75）	6（25）	9（37.5）	7（29.17）	8（33.33）	12（50）	7（29.17）	5（20.83）	12（50）
χ²值		0.000		0.118			0.958			0.000
P值		1.000		0.943			0.619			1.000

组别	例数	性别		LA分级			GEFV分级			裂孔疝
组别	例数	男性	女性	A	B	C	I	II	Ⅲ	裂孔疝
ARMA组	24	18（75）	6（25）	8（33.33）	7（29.17）	9（37.5）	9（37.5）	10（41.67）	5（20.83）	12（50）
PPI组	24	18（75）	6（25）	9（37.5）	7（29.17）	8（33.33）	12（50）	7（29.17）	5（20.83）	12（50）
χ²值		0.000		0.118			0.958			0.000
P值		1.000		0.943			0.619			1.000

组别	例数	GERD-HRQL		GERD		DeMeester评分		AET（%）
组别	例数	术前	术后6个月	术前	术后6个月	术前	术后6个月	术前	术后6个月
ARMA	24	34.0（31.00,37.00）	10.5（9.00,13.75）^a	12.0（11.00,14.00）	5.5（4.25,7.00）^a	64.0（58.93,71.63）	16.5（14.03,20.40）^a	20.1（18.35,22.78）	4.6（3.73,5.95）^a
PPI组	24	34.5（31.00, 37.00）	26.5（22.25,30.75）^a	12.5（11.00,14.75）	10.0（8.00,12.75）^a	64.2（58.28,70.78）	62.7（56.63,69.00）^a	20.4（18.30,22.23）	20.0（17.88,21.80）^a
Z值		-0.155	-5.926	-0.396	-5.258	-0.144	-5.938	-0.062	-5.939
P值		0.877	0.000	0.692	0.000	0.885	0.000	0.951	0.000

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