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

Condition(s) studied

Investigational drug(s) / intervention(s)

Argon Plasma Coagulation (APC): Ablation of gastric adenoma using argon plasma coagulation.

Endoscopic Mucosal Resection (EMR): Endoscopic resection of gastric adenoma by mucosal resection technique.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Local recurrence rate of gastric adenoma with low-grade dysplasia — 12 months after treatment
  Proportion of participants with histologically confirmed recurrence of gastric adenoma at the treated site, as determined by follow-up endoscopy and biopsy.

Trial sites (3)

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