Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, DoubleBlind, Active Control, Noninferiority, Multicenter, Phase 3 Study

Background/Aims@#The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of Mucosta Ⓡ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. @*Methods@#This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or Mucosta Ⓡ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; Mucosta Ⓡ , n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; Mucosta Ⓡ , n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. @*Results@#According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and Mucosta Ⓡ -treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was −4.01% (95% confidence interval [CI], –13.09% to 5.06%) in the ITT analysis and −4.44% (95% CI, –13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 Mucosta Ⓡ -treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. @*Conclusions@#The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (Mucosta Ⓡ ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Risk stratification of patients with gastric lesions indefinite for dysplasia

Background/Aims@#There are no definite guidelines for the management of gastric lesions diagnosed as indefinite for dysplasia (IND) by endoscopic forceps biopsy (EFB). Therefore, this study aimed to evaluate the clinical outcomes of gastric IND and predictive factors for gastric neoplasm. @*Methods@#This study included 457 patients with a first diagnosis of gastric IND by EFB between January 2005 and December 2013. Patient characteristics and endoscopic and pathological data were reviewed and compared. @*Results@#Of the 457 gastric IND patients, 128 (28%) were diagnosed with invasive carcinoma, 21 (4.6%) with high-grade dysplasia, 31 (6.8%) with low-grade dysplasia, and 277 (60.6%) as negative for dysplasia. Of lesions observed, 180 (39.4%) showed upgraded histology. Multivariate analysis revealed that surface erythema (odds ratio [OR], 2.804; 95% confidence interval [CI], 1.741 to 4.516), spontaneous bleeding (OR, 2.618; 95% CI, 1.298 to 5.279), lesion size ≥ 1 cm (OR, 5.762; 95% CI, 3.459 to 9.597), and depressed morphology (OR, 2.183; 95% CI, 1.155 to 4.124) were significant risk factors for high-grade dysplasia or adenocarcinoma. The ORs associated with 2 and ≥ 3 risk factors were 7.131 and 34.86, respectively. @*Conclusions@#Precautions should be taken in the management of gastric IND patients, especially when risk factors, including surface erythema, spontaneous bleeding, lesion size ≥ 1 cm, and depressed morphology are present. Considering the combined effect of the presence of multiple risk factors on the incidence of high-grade dysplasia or adenocarcinoma, endoscopic resection should be recommended if a gastric IND patient has at two or more of these factors.

Risk stratification of patients with gastric lesions indefinite for dysplasia

Background/Aims@#There are no definite guidelines for the management of gastric lesions diagnosed as indefinite for dysplasia (IND) by endoscopic forceps biopsy (EFB). Therefore, this study aimed to evaluate the clinical outcomes of gastric IND and predictive factors for gastric neoplasm. @*Methods@#This study included 457 patients with a first diagnosis of gastric IND by EFB between January 2005 and December 2013. Patient characteristics and endoscopic and pathological data were reviewed and compared. @*Results@#Of the 457 gastric IND patients, 128 (28%) were diagnosed with invasive carcinoma, 21 (4.6%) with high-grade dysplasia, 31 (6.8%) with low-grade dysplasia, and 277 (60.6%) as negative for dysplasia. Of lesions observed, 180 (39.4%) showed upgraded histology. Multivariate analysis revealed that surface erythema (odds ratio [OR], 2.804; 95% confidence interval [CI], 1.741 to 4.516), spontaneous bleeding (OR, 2.618; 95% CI, 1.298 to 5.279), lesion size ≥ 1 cm (OR, 5.762; 95% CI, 3.459 to 9.597), and depressed morphology (OR, 2.183; 95% CI, 1.155 to 4.124) were significant risk factors for high-grade dysplasia or adenocarcinoma. The ORs associated with 2 and ≥ 3 risk factors were 7.131 and 34.86, respectively. @*Conclusions@#Precautions should be taken in the management of gastric IND patients, especially when risk factors, including surface erythema, spontaneous bleeding, lesion size ≥ 1 cm, and depressed morphology are present. Considering the combined effect of the presence of multiple risk factors on the incidence of high-grade dysplasia or adenocarcinoma, endoscopic resection should be recommended if a gastric IND patient has at two or more of these factors.

Partially Covered Metal Stents May Not Prolong Stent Patency Compared to Uncovered Stents in Unresectable Malignant Distal Biliary Obstruction

BACKGROUND/AIMS: Controversy still exists regarding the benefits of covered self-expandable metal stents (SEMSs) compared to uncovered SEMSs. We aimed to compare the patency and stent-related adverse events of partially covered SEMSs (PC-SEMSs) and uncovered SEMSs in unresectable malignant distal biliary obstruction. METHODS: A total of 134 patients who received a PC-SEMS or uncovered SEMS for palliation of unresectable malignant distal biliary obstruction were reviewed retrospectively. The main outcome measures were stent patency, stent-related adverse events, and overall survival. RESULTS: The median stent patency was 118 days (range, 3 to 802 days) with PC-SEMSs and 105 days (range, 2 to 485 days) with uncovered SEMSs (p=0.718). The overall endoscopic revision rate due to stent dysfunction was 36.6% (26/71) with PC-SEMSs and 36.5% (23/63) with uncovered SEMSs (p=0.589). Tumor ingrowth was more frequent with uncovered SEMSs (4.2% vs 19.1%, p=0.013), but migration was more frequent with PC-SEMSs (11.2% vs 1.5%, p=0.04). The incidence of stent-related adverse events was 2.8% (2/71) with PC-SEMSs and 9.5% (6/63) with uncovered SEMSs (p=0.224). The median overall survival was 166 days with PC-SEMSs and 168 days with uncovered SEMSs (p=0.189). CONCLUSIONS: Compared to uncovered SEMSs, PC-SEMSs did not prolong stent patency in unresectable malignant distal biliary obstruction. Stent migration was more frequent with PC-SEMSs. However, tumor ingrowth was less frequent with PC-SEMSs compared to uncovered SEMSs.

Feedback Survey of the Effect, Burden, and Cost of the National Endoscopic Quality Assessment Program during the Past 5 Years in Korea

BACKGROUND/AIMS: In Korea, the nationwide gastric cancer screening program recommends biennial screening for individuals aged 40 years or older by way of either an upper gastrointestinal series or endoscopy. The national endoscopic quality assessment (QA) program began recommending endoscopy in medical institutions in 2009. We aimed to assess the effect, burden, and cost of the QA program from the viewpoint of medical institutions. METHODS: We surveyed the staff of institutional endoscopic units via e-mail. RESULTS: Staff members from 67 institutions replied. Most doctors were endoscopic specialists. They responded as to whether the QA program raised awareness for endoscopic quality (93%) or improved endoscopic practice (40%). The percentages of responders who reported improvements in the diagnosis of gastric cancer, the qualifications of endoscopists, the quality of facilities and equipment, endoscopic procedure, and endoscopic reprocessing were 69%, 60%, 66%, 82%, and 75%, respectively. Regarding reprocessing, many staff members reported that they had bought new automated endoscopic preprocessors (3%), used more disinfectants (34%), washed endoscopes longer (28%), reduced the number of endoscopies performed to adhere to reprocessing guidelines (9%), and created their own quality education programs (59%). Many responders said they felt that QA was associated with some degree of burden (48%), especially financial burden caused by purchasing new equipment. Reasonable quality standards (45%) and incentives (38%) were considered important to the success of the QA program. CONCLUSIONS: Endoscopic quality has improved after 5 years of the mandatory endoscopic QA program.

Is Endoscopic Resection for Type 1 Gastric Neuroendocrine Tumors Essential for Treatment?: Multicenter, Retrospective Long-term Follow-up Results

BACKGROUND/AIMS: Treatment of gastric neuroendocrine tumors is determined by type and size of the lesion. This study aimed to compare the long-term efficacy of observation and endoscopic resection for type 1 gastric neuroendocrine tumors without metastasis. MATERIALS AND METHODS: Among the 223 cases of gastric neuroendocrine tumors diagnosed between January 1996 and December 2011, 104 cases were type 1 gastric neuroendocrine tumors. Sixty-seven patients were treated endoscopically and 27 patients were observed without treatment. Endoscopic mucosal resection, endoscopic submucosal dissection, and polypectomy were the methods used for endoscopic treatment. Therapeutic efficacy and rates of complication and recurrence were evaluated retrospectively. RESULTS: In the endoscopic resection group, complete resection was observed in 53 patients (79.1%), and recurrence was observed in 14 patients (20.9%). On analysis of the observation group, no change was observed in 19 patients (70.4%), and tumor progression was observed in 8 patients (29.6%). Median follow-up duration was 49 months (31~210 months). No mortality was reported in either group during follow-up. CONCLUSIONS: Observation of type 1 gastric neuroendocrine tumors without metastasis yields results similar to those produced by endoscopic resection. Observation alone may be a safe treatment.

Usefulness of the Forrest Classification to Predict Artificial Ulcer Rebleeding during Second-Look Endoscopy after Endoscopic Submucosal Dissection

BACKGROUND/AIMS: Delayed post-endoscopic submucosal dissection (ESD) bleeding (DPEB) is difficult to predict and there is controversy regarding the usefulness of prophylactic hemostasis during second-look endoscopy. This study evaluated the risk factors related to DPEB, the relationship between clinical outcomes and the Forrest classification, and the results of prophylactic hemostasis during second-look endoscopy. METHODS: Second-look endoscopy was performed on the day after ESD to check for recent hemorrhage or potential bleeding and the presence of artificial ulcers in all patients. RESULTS: DPEB occurred in 42 of 581 patients (7.2%). Multivariate analysis determined that a specimen size ≥40 mm (odds ratio [OR], 3.03; p=0.003), and a high-risk Forrest classification (Forrest Ib+IIa+IIb; OR, 6.88; p<0.001) were risk factors for DPEB. DPEB was significantly more likely in patients classified with Forrest Ib (OR, 24.35; p<0.001), IIa (OR, 12.91; p<0.001), or IIb (OR, 8.31; p<0.001) ulcers compared with Forrest III ulcers. There was no statistically significant difference between the prophylactic hemostasis and non-hemostasis groups (Forrest Ib, p=0.938; IIa, p=0.438; IIb, p=0.397; IIc, p=0.773) during second-look endoscopy. CONCLUSIONS: The Forrest classification of artificial gastric ulcers during second-look endoscopy seems to be a useful tool for predicting delayed bleeding. However, routine prophylactic hemostasis during second-look endoscopy seemed to not be useful for preventing DPEB.

National Endoscopy Quality Improvement Program Remains Suboptimal in Korea

BACKGROUND/AIMS: We evaluated the characteristics of the National Cancer Screening Program (NCSP) and opinions regarding the National Endoscopy Quality Improvement Program (NEQIP). METHODS: We surveyed physicians performing esophagogastroduodenoscopy and/or colonoscopy screenings as part of the NCSP via e-mail between July and August in 2015. The 32-item survey instrument included endoscopic capacity, sedation, and reprocessing of endoscopes as well as opinions regarding the NEQIP. RESULTS: A total of 507 respondents were analyzed after the exclusion of 40 incomplete answers. Under the current capacity of the NCSP, the typical waiting time for screening endoscopy was less than 4 weeks in more than 90% of endoscopy units. Performance of endoscopy reprocessing was suboptimal, with 28% of respondents using unapproved disinfectants or not knowing the main ingredient of their disinfectants and 15% to 17% of respondents not following reprocessing protocols. Agreement with the NEQIP was optimal, because only 5.7% of respondents did not agree with NEQIP; however, familiarity with the NEQIP was suboptimal, because only 37.3% of respondents were familiar with the NEQIP criteria. CONCLUSIONS: The NEQ-IP remains suboptimal in Korea. Given the suboptimal performance of endoscopy reprocessing and low familiarity with the NEQIP, improved quality in endoscopy reprocessing and better understanding of the NEQIP should be emphasized in Korea.

Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis

Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.

Online Registry for Nationwide Database of Current Trend of Helicobacter pylori Eradication in Korea: Interim Analysis

Eradication of Helicobacter pylori using first-line therapy is becoming less effective. Subjects who had been treated for H. pylori infection were prospectively enrolled through an on-line database registry from October 2010 to December 2012. Demographic data, detection methods, treatment indication, regimens, durations, compliance, adverse events, and eradication results for H. pylori infection were collected. Data of 3,700 patients from 34 hospitals were analyzed. The overall eradication rate of the first-line therapy was 73.0%. Eradication failure was significantly associated with old age, concomitant medication, and comorbidity. Regional differences in eradication rates were observed. The most common first-line therapy was proton pump inhibitor-based triple therapy (standard triple therapy, STT) for 7 days (86.8%). The eradication rates varied with regimens, being 73% in STT, 81.8% in bismuth-based quadruple therapy, 100% in sequential therapy, and 90.3% in concomitant therapy. The eradication rate in treatment-naïve patients was higher than that in patients previously treated for H. pylori infection (73.8% vs. 58.5%, P < 0.001). The overall eradication rate for second-line therapy was 84.3%. There was no statistical difference in eradication rates among various regimens. H. pylori eradication rate using STT is decreasing in Korea and has become sub-optimal, suggesting the need for alternative regimens to improve the efficacy of first-line therapy for H. pylori infection.

The Korean guideline for gastric cancer screening

Despite improvements in treatment modalities, gastric cancer is the second cause of mortality among Korean men and third among females in Korea. Korea implemented a gastric cancer screening program for the general population in 1999. However, the effectiveness and harms of gastric cancer screening using gastric endoscopy and upper gastrointestinal (UGI) series have not been fully evaluated. In an effort to evaluate the screening program, the Korean multidisciplinary expert committee for developing a gastric cancer screening guideline systematically reviewed the evidence regarding the benefits and harms of gastric cancer screening, and developed an evidence-based clinical guideline. There is 'low' level evidence that gastric cancer screening using gastric endoscopy or UGI series can reduce gastric cancer mortality for asymptomatic adults aged between 40 to 74 years. The benefits of gastric cancer screening using gastric endoscopy are substantially higher than its harms, while the benefits of screening with UGI series are moderately higher. We recommend that asymptomatic adults from 40 to 75 years of age undergo biannual gastric cancer screening using gastric endoscopy (recommendation B). Gastric cancer screening using UGI series in asymptomatic adults aged between 40 to 74 years may be recommended based on clinicians' judgment regarding the patient's risk and the patient's preference (recommendation C). There is insufficient evidence to assess the benefits and harms of gastric cancer screening for adults aged between 75 to 84 years (recommendation I). We recommend against gastric cancer screening for adults older than 85 years (recommendation D).

Diagnostic Accuracy of Brush Cytology with Direct Smear and Cell-block Techniques according to Preparation Order and Tumor Characteristics in Biliary Strictures / 대한소화기학회지

BACKGROUND/AIMS: There are few data supporting the diagnostic yield of brush cytology depending on the order of cytologic preparation method or the location or shape of tumors in biliary strictures. We investigated diagnostic yields and variations in brush cytology with direct smear and cell-block preparations according to sampling preparation sequence and tumor location and shape in biliary strictures. METHODS: Patients who had undergone ERCP with tissue sampling between August 2009 and April 2013 were analyzed retrospectively. Group A was examined using brush cytology with direct smear followed by cell-block with or without biopsy, while the reverse order was performed for group B. RESULTS: Among 138 enrolled patients, 92 patients (A: 36, B: 56) underwent both brush cytology with direct smear and cell-block preparations. No differences in sensitivity, specificity, or accuracy were observed according to the sampling preparation method and the location or shape of tumors in biliary strictures. The cellularity observed from brush cytology with direct smear was better than that from cell-block according to the location of the tumor (p<0.01). The diagnostic yield was increased in both groups with addition of an endobiliary biopsy. CONCLUSIONS: No difference in diagnostic accuracy was observed between the sequences of preparation for brush cytology with direct smear and cell-block techniques. Brush cytology showed better cellularity for diagnosis.

Electrohydraulic Lithotripsy of an Impacted Enterolith Causing Acute Afferent Loop Syndrome

Afferent loop syndrome caused by an impacted enterolith is very rare, and endoscopic removal of the enterolith may be difficult if a stricture is present or the normal anatomy has been altered. Electrohydraulic lithotripsy is commonly used for endoscopic fragmentation of biliary and pancreatic duct stones. A 64-year-old man who had undergone subtotal gastrectomy and gastrojejunostomy presented with acute, severe abdominal pain for a duration of 2 hours. Initially, he was diagnosed with acute pancreatitis because of an elevated amylase level and pain, but was finally diagnosed with acute afferent loop syndrome when an impacted enterolith was identified by computed tomography. We successfully removed the enterolith using direct electrohydraulic lithotripsy conducted using a transparent cap-fitted endoscope without complications. We found that this procedure was therapeutically beneficial.

Endoscopic Submucosal Dissection Using a Novel Versatile Knife: An Animal Feasibility Study (with Video)

BACKGROUND/AIMS: In order to reduce the procedure time and the number of accessory changes during endoscopic submucosal dissection (ESD), we developed a novel versatile knife, which has the combined advantages of several conventional knives. The aim of this study was to compare the efficacy, safety, and histological quality of ESD performed using this novel versatile knife and a combination of several conventional knives. METHODS: This was an in vivo animal study comparing two different modalities of ESD in mini-pigs. Completion time of each resection was documented, and the resected specimens were retrieved and evaluated for completeness. To assess the quality control of the procedures and adverse events, detailed histopathological examinations were performed. RESULTS: A total of 18 specimens were dissected by ESD safely and easily (nine specimens using the new versatile knife; nine specimens by mixing conventional knives). All resections were completed as en bloc resections. There was no significant difference in procedure time between the 2 modalities (456 seconds vs. 355 seconds, p=0.258) and cutting speed (1.983 mm2/sec vs. 1.57 mm2/sec, p=1.000). The rate of adverse events and histological quality did not statistically differ between the modalities. CONCLUSIONS: ESD with a versatile knife appeared to be an easy, safe, and technically efficient method.

Predictive Factors for Endoscopic Hemostasis in Patients with Upper Gastrointestinal Bleeding

No abstract available.

A Survey of the Radiation Exposure Protection of Health Care Providers during Endoscopic Retrograde Cholangiopancreatography in Korea

BACKGROUND/AIMS: During endoscopic retrograde cholangiopancreatography (ERCP), all efforts should be made to be aware of radiation hazards and to reduce radiation exposure. The aim of this study was to investigate the status of radiation protective equipment and the awareness of radiation exposure in health care providers performing ERCP in Korean hospitals. METHODS: A survey with a total of 42 questions was sent to each respondent via mail or e-mail between October 2010 and March 2011. The survey targeted nurses and radiation technicians who participated in ERCP in secondary or tertiary referral centers. RESULTS: A total of 78 providers from 38 hospitals responded to the surveys (response rate, 52%). The preparation and actual utilization rates of protective equipment were 55.3% and 61.9% for lead shields, 100% and 98.7% for lead aprons, 47.4% and 37.8% for lead glasses, 97.4% and 94.7% for thyroid shields, and 57.7% and 68.9% for radiation dosimeters, respectively. The common reason for not wearing protective equipment was that the equipment was bothersome, according to 45.7% of the respondents. CONCLUSIONS: More protective equipment, such as lead shields and lead glasses, should be provided to health care providers involved in ERCP. In particular, the actual utilization rate for lead glasses was very low.

Endoscopic Removal of a Proximally Migrated Metal Stent during Balloon Sweeping after Stent Trimming

Placement of a self-expanding metal stent (SEMS) is an effective method for palliation of a malignant biliary obstruction. However, metal stents can cause various complications, including stent migration. Distally migrated metal stents, particularly covered SEMS, can be removed successfully in most cases. Stent trimming using argon plasma coagulation may be helpful in difficult cases despite conventional methods. However, no serious complications related to the trimming or remnant stent removal method have been reported due to the limited number of cases. In particular, proximal migration of a remnant fragmented metal stent after stent trimming followed by balloon sweeping has not been reported. We report an unusual case of proximal migration of a remnant metal stent during balloon sweeping following stent trimming by argon plasma coagulation. The remnant metal stent was successfully removed with rotation technique using a basket and revised endoscopically.

How Can We Maximize Skills for Non-Variceal Upper Gastrointestinal Bleeding: Injection, Clipping, Burning, or Others?

Endoscopy has its role in the primary diagnosis and management of acute non-variceal upper gastrointestinal bleeding. Main roles of endoscopy are identifying high risk stigmata lesion, and performing endoscopic hemostasis to lower the rebleeding and mortality risks. Early endoscopy within the first 24 hours enables risk classification according to clinical and endoscopic criteria, which guide safe and prompt discharge of low risk patients, and improve outcomes of high risk patients. Techniques including injection therapy, ablative therapy and mechanical therapy have been studied over the recent decades. Combined treatment is more effective than injection treatment, and single treatment with mechanical or thermal method is safe and effective in peptic ulcer bleeding. Specific treatment and correct decisions are needed in various situations depending on the site, location, specific characteristics of lesion and patient's clinical conditions.

A Case of Delayed Fatal Hemobilia after Radiofrequency Ablation of Hepatocellular Carcinoma

Radiofrequency ablation (RFA) has been accepted as a safe and effective treatment for unresectable hepatic tumors because of the advantages of a minimally invasive procedure and the local treatment effect. Although RFA can be performed safely in most patients, early and late complications related to mechanical or thermal damage may be observed at follow-up examination. Hemobilia is a very rare complication of RFA and most hemobilia is an immediate complication. However, delayed hemobilia is an even more rare complication after RFA and is known to be a fatal complication. We present a case of delayed fatal hemobilia after RFA for hepatocellular carcinoma.

Successful Primary Infliximab Treatment of Orofacial Crohn's Disease without Gastrointestinal Manifestation / 대한소화기학회지

Crohn's disease is a chronic inflammatory bowel disease that can involve the whole gastrointestinal tract. The orofacial manifestation of Crohn's disease, which is rare, can develop irrespective of intestinal involvement. These orofacial lesions are often misdiagnosed as simple oral ulcers. Corticosteroids are the mainstay of therapy for orofacial Crohn's disease. However, infliximab, the chimeric monoclonal antibody to tumor necrosis factor-alpha, is now considered as a primary treatment because of the disease's relatively high rate of steroid resistance. We present a case of deep oral ulcer and periorbital swelling in a 65-year-old woman. She was diagnosed with intestinal Crohn's disease 7 years ago, which was in remission after treatment with an immunosuppressive agent (azathioprine). The patient was given the diagnosed with orofacial Crohn's disease and successfully treated with infliximab.