Argon Plasma Coagulation Versus Endoscopic Mucosal Resection for Gastric Adenoma (CLER-GA)

Gastric adenomas with low-grade dysplasia (LGD) are considered precancerous lesions of the stomach. While these lesions carry a lower risk of progressing to gastric cancer compared with high-grade dysplasia, there is still uncertainty about the best way to manage them. International medical guidelines differ in their recommendations, and for very small lesions (1 cm or smaller), some guidelines provide no clear direction. This creates uncertainty for both patients and physicians about whether to treat these lesions or simply observe them over time. Two endoscopic treatment methods are widely used in clinical practice: endoscopic mucosal resection (EMR) and argon plasma coagulation (APC). EMR involves lifting and cutting out the lesion. Its major advantage is that it removes the lesion completely and allows for detailed pathological examination. However, EMR can be technically more demanding, takes more time, and may carry higher risks of complications such as bleeding or perforation. It also usually involves higher medical costs. In contrast, APC is a technique that uses ionized argon gas and electrical current to coagulate tissue without direct contact. APC is simpler to perform, takes less time, and is generally less invasive. Patients undergoing APC may have shorter hospital stays, lower costs, and fewer complications. However, APC does not provide a specimen for pathology, so complete removal of the lesion cannot be confirmed. This means there is a possibility of local recurrence. Several retrospective studies have examined APC for gastric LGD, and results have suggested it may be effective for small lesions. However, recurrence rates reported in previous studies have varied widely, from less than 2% to more than 20%. Importantly, no large randomized controlled trial has directly compared APC with EMR for small gastric LGD lesions. This study seeks to fill that gap. The goal of this clinical trial is to compare the effectiveness and safety of APC and EMR for treating gastric adenomas that are 1 cm or smaller with low-grade dysplasia. Specifically, the study aims to determine whether APC is "non-inferior" to EMR in preventing local recurrence of these lesions. In other words, researchers want to know if APC works just as well as EMR in controlling the disease, while also offering potential advantages such as fewer complications, shorter procedure time, and lower costs. Participants in this study will: Be adults (age 20 or older) diagnosed with a gastric adenoma 1 cm or smaller with low-grade dysplasia. Be randomly assigned (by chance, like flipping a coin) to receive either APC or EMR. Receive standard medical care after the procedure, including medications to help the stomach heal. Return for follow-up endoscopy at 3 months and 12 months after the procedure. During these visits, the treated area will be checked carefully, and biopsies may be taken to determine whether the lesion has recurred. Provide information about any complications, the duration of the procedure, and their recovery experience. The main question is whether APC can prevent recurrence of gastric adenomas as effectively as EMR. Secondary questions include how the two treatments differ in terms of complications (such as bleeding or perforation) and procedure time. Both APC and EMR are already established and commonly used treatments for gastric lesions. By directly comparing these two methods in a randomized controlled trial, this study will provide important evidence to guide future recommendations for patients with small gastric adenomas. The findings may help physicians and patients choose the best treatment option, balancing safety, effectiveness, and convenience.

Sex

All

Minimum age

20 Years

Inclusion Criteria:

* Adults aged 20 years or older
* Diagnosed with gastric adenoma with low-grade dysplasia measuring ≤ 1 cm on endoscopy
* Scheduled to undergo endoscopic treatment
* Able and willing to provide written informed consent

Exclusion Criteria:

* Previous treatment for gastric adenoma or gastric cancer
* History of gastrectomy
* Diagnosis of gastric cancer or high-grade dysplasia at the time of enrollment
* Presence of multiple gastric adenomas
* Pregnant, breastfeeding, or possibility of pregnancy
* Uncontrolled chronic illnesses that may interfere with trial participation (e.g., uncontrolled hypertension, uncontrolled diabetes, chronic kidney disease, ascites, heart failure, psychiatric disorders)

• RESULTKim IH, Kang SJ, Choi W, Seo AN, Eom BW, Kang B, Kim BJ, Min BH, Tae CH, Choi CI, Lee CK, An HJ, Byun HK, Im HS, Kim HD, Cho JH, Pak K, Kim JJ, Bae JS, Yu JI, Lee JW, Choi J, Kim JH, Choi M, Jung MR, Seo N, Eom SS, Ahn S, Kim SJ, Lee SH, Lim SH, Kim TH, Han HS; Development Working Group for the Korean Practice Guideline for Gastric Cancer 2024 Task Force Team. Korean Practice Guidelines for Gastric Cancer 2024: An Evidence-based, Multidisciplinary Approach (Update of 2022 Guideline). J Gastric Cancer. 2025 Jan;25(1):5-114. doi: 10.5230/jgc.2025.25.e11. PMID 39822170
• RESULTPimentel-Nunes P, Libanio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, Esposito G, Lemmers A, Maselli R, Messmann H, Pech O, Pioche M, Vieth M, Weusten BLAM, van Hooft JE, Deprez PH, Dinis-Ribeiro M. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022 Jun;54(6):591-622. doi: 10.1055/a-1811-7025. Epub 2022 May 6. PMID 35523224
• RESULTZhao G, Xue M, Hu Y, Lai S, Chen S, Wang L. How Commonly Is the Diagnosis of Gastric Low Grade Dysplasia Upgraded following Endoscopic Resection? A Meta-Analysis. PLoS One. 2015 Jul 16;10(7):e0132699. doi: 10.1371/journal.pone.0132699. eCollection 2015. PMID 26182344
• RESULTCho SJ, Choi IJ, Kim CG, Lee JY, Kook MC, Park S, Ryu KW, Lee JH, Kim YW. Risk of high-grade dysplasia or carcinoma in gastric biopsy-proven low-grade dysplasia: an analysis using the Vienna classification. Endoscopy. 2011 Jun;43(6):465-71. doi: 10.1055/s-0030-1256236. Epub 2011 Mar 21. PMID 21425043
• RESULTJung SJ, Cho SJ, Choi IJ, Kook MC, Kim CG, Lee JY, Park SR, Lee JH, Ryu KW, Kim YW. Argon plasma coagulation is safe and effective for treating smaller gastric lesions with low-grade dysplasia: a comparison with endoscopic submucosal dissection. Surg Endosc. 2013 Apr;27(4):1211-8. doi: 10.1007/s00464-012-2577-9. Epub 2012 Oct 18. PMID 23076459