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

NCT07161479 | Recruiting

• 1 other identifier: SMC 2025-04-026-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Precancerous Conditions; Gastric Adenoma; Stomach Neoplasms; Dysplasia Stomach

Keywords

Gastric adenoma; Low-grade dysplasia; Precancerous gastric lesion; Argon plasma coagulation (APC); Endoscopic mucosal resection (EMR); Endoscopic therapy; Local recurrence; Randomized controlled trial; Stomach neoplasms

Outcome Measures

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.

  12 months after treatment

Secondary Outcomes (4)

• Procedure outcomes

  At the time of index procedure

• Procedure-related bleeding

  Within 4 weeks after treatment

• Procedure-related perforation

  Within 4 weeks after treatment

• Procedure time

  At the time of index procedure

Study Arms (2)

Argon Plasma Coagulation (APC)

EXPERIMENTAL

Participants undergo argon plasma coagulation for gastric adenoma ≤ 1 cm.

Procedure: Argon Plasma Coagulation (APC)

Endoscopic Mucosal Resection (EMR)

ACTIVE COMPARATOR

Participants undergo endoscopic mucosal resection for gastric adenoma ≤ 1 cm.

Procedure: Endoscopic Mucosal Resection (EMR)

Interventions

Argon Plasma Coagulation (APC) PROCEDURE

Ablation of gastric adenoma using argon plasma coagulation.

Argon Plasma Coagulation (APC)

Endoscopic Mucosal Resection (EMR) PROCEDURE

Endoscopic resection of gastric adenoma by mucosal resection technique.

Endoscopic Mucosal Resection (EMR)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead
• Samsung Medical Center, Sungkyunkwan University School of Medicine: collaborator

Study Sites (3)

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Kangbuk Samsung hospital

Seoul, 03181, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (5)

• Kim 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 RESULT

• Pimentel-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 RESULT

• Zhao 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 RESULT

• Cho 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 RESULT

• Jung 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 RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Precancerous Conditions

Interventions

Argon Plasma Coagulation; Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Electrocoagulation; Cautery; Therapeutics; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Hyuk Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Hyo-Joon Yang, MD, PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Young-Il Kim, MD, PhD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

• Jong Yeul Lee, MD, PhD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

82-2-3410-6853; minjicho630@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the treatment allocation. Due to the nature of the procedures, endoscopists performing APC or EMR cannot be blinded. Outcome assessments are based on objective endoscopic and histologic findings, and therefore independent masking of assessors was not applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a multicenter, randomized, single-blinded, parallel assignment trial. Eligible participants with gastric adenomas ≤ 1 cm will be randomly assigned in a 1:1 ratio to undergo either argon plasma coagulation (APC) or endoscopic mucosal resection (EMR). Patients will be blinded to treatment allocation, while treating endoscopists cannot be blinded due to the nature of the procedures.

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 8, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be made available beginning 6 months after publication of the main study results and will be accessible for up to 3 years thereafter.
• Access Criteria: De-identified individual participant data (IPD) and supporting information (study protocol, statistical analysis plan) will be made available to qualified researchers affiliated with academic or medical institutions. Interested researchers must submit a written proposal describing the intended use of the data. Access will be granted after review and approval by the principal investigator. A data use agreement must be signed prior to release. Data will be shared through a secure institutional platform or by direct request to the principal investigator.

Locations

KR (3)