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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorSamsung Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Argon Plasma Coagulation (APC)

    Procedure/Surgery

    Ablation of gastric adenoma using argon plasma coagulation.

  • Endoscopic Mucosal Resection (EMR)

    Procedure/Surgery

    Endoscopic resection of gastric adenoma by mucosal resection technique.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Argon Plasma Coagulation (APC)Experimental treatment 1 intervention
Group B: Endoscopic Mucosal Resection (EMR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Local recurrence rate of gastric adenoma with low-grade dysplasia

Proportion of participants with histologically confirmed recurrence of gastric adenoma at the treated site, as determined by follow-up endoscopy and biopsy.

Time frame
12 months after treatment

Secondary outcomes

1

Procedure outcomes

Proportion of participants with complete ablation by APC or en bloc resection by EMR.

Time frame
At the time of index procedure
2

Procedure-related bleeding

Proportion of participants with bleeding defined as a hemoglobin decrease \>2 g/dL accompanied by hematemesis, melena, or hypotension, occurring within 4 weeks of treatment.

Time frame
Within 4 weeks after treatment
3

Procedure-related perforation

Proportion of participants with perforation, defined as direct endoscopic evidence during the procedure or free air detected on chest radiograph after the procedure. Subcategories include gross perforation and microscopic perforation.

Time frame
Within 4 weeks after treatment
4

Procedure time

Average duration of the endoscopic procedure (APC or EMR), measured in minutes and seconds.

Time frame
At the time of index procedure

Other outcomes

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